EpilepsyPhase 2T-WAVENCT03406702
CX-8998 for Absence Seizures
A Phase 2 study testing CX-8998 in people with Epilepsy, run by Jazz Pharmaceuticals at 7 sites in United States.
Trial summary
This is a Phase 2a, open-label study consisting of a screening period of up to 4 weeks and a 4-dose-titration treatment period to a dose of up to 10 mg twice daily (BID) of CX-8998, followed by a 1-week safety follow-up period after the last dose of study medication. Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- CX-8998
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 7 sitesUnited States
- Study dates
- 25 Feb 2018to 29 Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed informed consent form (ICF) indicating that the subject has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.
- Men or non-pregnant, non-breastfeeding women 16 to 55 years-of-age who are able to read and understand written and spoken local language.
- Clinical diagnosis of IGE (including, but not limited to, CAE, JAE, juvenile myoclonic epilepsy, or Jeavons syndrome) with absence seizures consistent with the International League against Epilepsy Revised Classification of Seizures (2017).
- Absence seizures persisting despite standard of care (SOC) treatment, defined as treatment with at least 2 AEDs appropriate for the patient's epilepsy syndrome. SOC failure, per investigator discretion, will be defined as insufficient clinical response or intolerable side effects, which precludes use of the appropriate AED.
- Observation of at least 3 instances of generalized discharges of approximately 2.5 - 4 Hz lasting ≥2 seconds via 24-hour ambulatory EEG (centrally reviewed), with approximately 75% normal background based on age and medication use per the central EEG reader's discretion. Intermittent focal spikes are allowed.
- On stable doses of one or more antiepileptic medication(s) for at least 30 days. If a subject is not on medication, adequate documentation justifying lack of therapy may be acceptable for the subject after sponsor review. Ketogenic, modified Atkins diet (MAD), or low glycemic diet with stable carbohydrate ratio for at least 30 days before screening is an acceptable antiepileptic therapy. Vagal nerve stimulation at stable settings (for at least 30 days before screening), without use of the magnet, is also acceptable.
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- Body weight ≥ 45 kg at screening.
- Subjects with reproductive capability including all males and women of child-bearing potential (WOCBP) must agree to practice continuous abstinence or adequate contraception methods (appropriate double barrier method or oral, patch, implant, or injectable contraception) from as soon as feasible during screening period until at least 30 days after the last dose (i.e., intermittent abstinence based on "rhythm", temperature monitoring, or other means of timing is not acceptable). WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, and/or bilateral oophorectomy) or is not post-menopausal. Post-menopausal is defined as amenorrhea ≥ 12 consecutive months without another cause, and a documented serum follicle stimulating hormone (FSH) level ≥ 35 mIU/mL.
- Male subjects with a partner of child-bearing potential must be surgically sterilized or be willing to use condoms with spermicide from as soon as feasible during screening period until at least 30 days after the last dose.
- Able and willing to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Approval by the sponsor medical personnel or delegate as to final eligibility for the study.
Who cannot join
- History of surgical intervention for treatment of epilepsy.
- Additional seizure (clinical and electrographic) types, including, but not limited to, epileptic spasms, generalized tonic seizures, atonic seizures, or focal seizures. Subjects with GTCS or myoclonic seizures are eligible for the study.
- Inadequately treated psychotic or mood disorder (e.g., schizophrenia, major depression, bipolar disorder).
- Presence of severe intellectual disability, severe autism spectrum disorder, or severe developmental disorder such that the subject cannot sign the ICF or cannot cooperate with the study procedures.
- Presence of positive urine drug screen for drugs of abuse, except if this is explained by use of an allowed prescription medicine.
- Regular use of more than 2 standard drinks of alcohol per day (28 grams of pure alcohol).
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- Hypersensitivity/allergic reaction to other T-type calcium agents, such as (but not limited to) ethosuximide and zonisamide.
- Use of strong CYP3A4 inhibitors, including prescription or non-prescription drugs or other products (i.e. grapefruit juice), which cannot be discontinued at least 2 weeks prior to Day 1 of dosing and throughout the study (Appendix C).
- Concurrent illnesses that would be a contraindication to trial participation, including, but not limited to:
- Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before screening
- NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled hypertension
- Clinically significant ECG abnormality per the Investigator assessment or any of the following: i) QTcF ≥450 msec (males) or ≥470 msec (females) ii) PR interval ≥250 msec iii) Atrioventricular block of second degree or higher, including Mobitz I iv) Persistent sinus bradycardia ≤ 50 beats per minute; persistent means the bradycardia is present on the first ECG and on one repeat ECG performed on another day v) For other ECG findings (e.g., including, but not necessarily limited to, tachycardia, bundle branch block, frequent ectopic beats, etc.) the Investigator should send a scanned, identity-blinded copy of the ECG tracing to the Study Safety Representative for review.
- Positive result for HIV, Hepatitis B [indicating ongoing infection], or Hepatitis C at screening or otherwise known ongoing infection with HIV, hepatitis B, or hepatitis C, unless curative therapy completed; for hepatitis C curative therapy is defined as negative PCR for HCV RNA.
- Significant hepatic (AST/ALT or bilirubin ≥ 2X upper limit of normal) or renal disease (creatinine clearance ≤39 mL/min) at screening.
- History of alcohol or substance abuse within the last year.
- A current C-SSRS score of 4 or 5 at screening or history of suicide attempt.
- Psychological, social, familial, or geographical reasons that would hinder or prevent compliance with the requirements of the protocol or compromise the informed consent process.
- Any other condition and/or situation that causes the Investigator or Study Safety Representative to deem a subject unsuitable for the study (including, but not limited to, expected study medication non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures).
- Treatment with an investigational agent within 30 days prior to the first dose of CX-8998 or planning to receive an investigational agent during the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Bluegrass Epilepsy Research, LLC
Lexington, Kentucky, 40504
Arkansas Epilepsy Program
Little Rock, Arkansas, 72205
NYU Comprehensive Epilepsy Center
New York, New York, 10016
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Florida
Tampa, Florida, 33612
About this study
Official title: A Phase 2a, Safety, Tolerability, Pharmacokinetics, and Quantitative EEG Study of CX-8998 in Adolescents and Adults With Idiopathic Generalized Epilepsy With Absence Seizures
This is a Phase 2a, open-label study consisting of a screening period of up to 4 weeks and a 4-dose-titration treatment period to a dose of up to 10 mg twice daily (BID) of CX-8998, followed by a 1-week safety follow-up period after the last dose of study medication.
Read the detailed description
This is a Phase 2a, open-label study consisting of a screening period of up to 4 weeks and a 4-dose-titration treatment period to a dose of up to 10 mg twice daily (BID) of CX-8998, followed by a 1-week safety follow-up period after the last dose of study medication.
Subjects will participate for a total of up to 9 weeks, including screening, the 4-week treatment period and follow-up.
- Conditions
- Epilepsy
- Being tested
- CX-8998
- Keywords
- Epilepsy, Idiopathic Generalized Epilepsy, Absence Seizures
- Medical subject headings
- Epilepsy, Epilepsy, Idiopathic Generalized, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CX-8998Drug
T-type calcium channel blocker
| Study group | Role | What they receive |
|---|---|---|
| CX-8998 | Experimental | T-type calcium channel blocker Receives: Drug: CX-8998 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to End of Treatment in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Fridericia's Correction Formula (QTCF) is a formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates.
Measured: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Clinical Alanine Aminotransferase Serum Chemistry Concentration
Clinical safety laboratory assessment in alanine aminotransferase serum chemistry concentration.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Clinical Albumin Serum Chemistry Concentration
Clinical safety laboratory assessment in albumin serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Clinical Albumin/Globulin Serum Chemistry Concentration
Clinical safety laboratory assessment in albumin/globulin serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Clinical Alkaline Phosphatase Serum Chemistry Concentration
Clinical safety laboratory assessment in alkaline phosphatase serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Clinical Aspartate Aminotransferase Serum Chemistry Concentration
Clinical safety laboratory assessment in aspartate aminotransferase serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline Clinical Blood Urea Nitrogen/Creatinine Serum Chemistry Concentration
Clinical safety laboratory assessment in BUN/Creatinine serum chemistry.
Measured: Baseline (Day 1)
Change From Baseline to End of Treatment in Clinical Bilirubin Serum Chemistry Concentration
Clinical safety laboratory assessment in bilirubin serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Clinical Blood Urea Nitrogen Serum Chemistry Concentration
Clinical safety laboratory assessment in blood urea nitrogen serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Clinical Carbon Dioxide Serum Chemistry Concentration
Clinical safety laboratory assessment in carbon dioxide serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Clinical Chloride Serum Chemistry Concentration
Clinical safety laboratory assessment in chloride serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Clinical Calcium Serum Chemistry Concentration
Clinical safety laboratory assessment in calcium serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Clinical Cholesterol Serum Chemistry Concentration
Clinical safety laboratory assessment in cholesterol serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline Clinical Cholesterol/HDL-Cholesterol Serum Chemistry Concentration
Clinical safety laboratory assessment in cholesterol/HDL-cholesterol serum chemistry.
Measured: Baseline (Day 1)
Change From Baseline to End of Treatment in Clinical Creatine Kinase Serum Chemistry Concentration
Clinical safety laboratory assessment in creatine kinase serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Clinical Creatinine Serum Chemistry Concentration
Clinical safety laboratory assessment in creatinine serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Clinical Globulin Serum Chemistry Concentration
Clinical safety laboratory assessment in globulin serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline Clinical Glomerular Filtration Rate (GFR) Adjusted for Body Surface Area (BSA) Serum Chemistry Concentration
Clinical safety laboratory assessment in glomerular filtration rate adjusted for BSA chemistry.
Measured: Baseline (Day 1)
Change From Baseline to End of Treatment in Clinical Estimated Glomerular Filtration Rate (GFR) Serum Chemistry Concentration
Clinical safety laboratory assessment in GFR serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Clinical Glucose Serum Chemistry Concentration
Clinical safety laboratory assessment in glucose serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline Clinical HDL Cholesterol Serum Chemistry Concentration
Clinical safety laboratory assessment in HDL cholesterol serum chemistry.
Measured: Baseline (Day 1)
Baseline Clinical LDL Cholesterol Serum Chemistry Concentration
Clinical safety laboratory assessment in LDL cholesterol serum chemistry.
Measured: Baseline (Day 1)
Change From Baseline to End of Treatment in Clinical Lactate Dehydrogenase Serum Chemistry Concentration
Clinical safety laboratory assessment in lactate dehydrogenase serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Clinical Magnesium Serum Chemistry Concentration
Clinical safety laboratory assessment in magnesium serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline Clinical Non-HDL Cholesterol Serum Chemistry Concentration
Clinical safety laboratory assessment in non-HDL cholesterol serum chemistry.
Measured: Baseline (Day 1)
Change From Baseline to End of Treatment in Clinical Phosphate Serum Chemistry Concentration
Clinical safety laboratory assessment in phosphate serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Clinical Potassium Serum Chemistry Concentration
Clinical safety laboratory assessment in potassium serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Clinical Protein Serum Chemistry Concentration
Clinical safety laboratory assessment in protein serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Clinical Sodium Serum Chemistry Concentration
Clinical safety laboratory assessment in sodium serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Clinical Triglycerides Serum Chemistry Concentration
Clinical safety laboratory assessment in triglycerides serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Clinical Urate Serum Chemistry Concentration
Clinical safety laboratory assessment in urate serum chemistry.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Basophils Hematology Assessment
Clinical safety laboratory basophils hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Basophils/Leukocytes Hematology Assessment
Clinical safety laboratory basophils/leukocytes hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Eosinophils Hematology Assessment
Clinical safety laboratory eosinophils hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Eosinophils/Leukocytes Hematology Assessment
Clinical safety laboratory eosinophils/leukocytes hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Mean Corpuscular Hemoglobin (HGB) Concentration Hematology Assessment
Clinical safety laboratory mean corpuscular HGB concentration hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Mean Corpuscular Hemoglobin (HGB) Hematology Assessment
Clinical safety laboratory mean corpuscular HGB hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Mean Corpuscular Volume Hematology Assessment
Clinical safety laboratory mean corpuscular volume hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Erythrocytes Hematology Assessment
Clinical safety laboratory erythrocytes hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Erythrocytes Distribution Width Hematology Assessment
Clinical safety laboratory erythrocytes distribution width hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Hematocrit Hematology Assessment
Clinical safety laboratory hematocrit hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Hemaglobin Hematology Assessment
Clinical safety laboratory hemaglobin hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Leukocytes Hematology Assessment
Clinical safety laboratory leukocytes hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Lymphocytes Hematology Assessment
Clinical safety laboratory lymphocytes hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Lymphocytes/Leukocytes Hematology Assessment
Clinical safety laboratory lymphocytes/leukocytes hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Mean Platelet Volume Hematology Assessment
Clinical safety laboratory mean platelet volume hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Monocytes Hematology Assessment
Clinical safety laboratory monocytes hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Monocytes/Leukocytes Hematology Assessment
Clinical safety laboratory monocytes/leukocytes hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Neutrophils Hematology Assessment
Clinical safety laboratory neutrophils hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Neutrophils/Leukocytes Hematology Assessment
Clinical safety laboratory neutrophils/leukocytes hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Platelets Hematology Assessment
Clinical safety laboratory platelets hematology assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline to End of Treatment in Bacteria Urinalysis Assessment
Clinical safety laboratory bacteria urinalysis assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline to End of Treatment in Urine Bilirubin Urinalysis Assessment
Clinical safety laboratory urine bilirubin urinalysis assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline to End of Treatment in Epithelial Cells Urinalysis Assessment
Clinical safety laboratory epithelial cells urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-10 epithelial cells/high power field (hpf). A worse outcome is >10 epithelial cells.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline to End of Treatment in Urine Erythrocytes Urinalysis Assessment
Clinical safety laboratory urine erythrocytes urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-2 erythrocytes/high power field (hpf). A better outcome is 0 or "none seen."
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline to End of Treatment in Urine Glucose Urinalysis Assessment
Clinical safety laboratory urine glucose urinalysis assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline to End of Treatment in Ketones Urinalysis Assessment
Clinical safety laboratory ketones urinalysis assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline to End of Treatment in Leukocyte Esterase Urinalysis Assessment
Clinical safety laboratory leukocyte esterase urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is "negative." An abnormal assessment or worse outcome is a positive assessment (i.e., 2+).
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline to End of Treatment in Urine Leukocytes Urinalysis Assessment
Clinical safety laboratory urine leukocytes urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-5 leukocytes/high power field (hpf). An abnormal assessment or worse outcome is >5 leukocytes/hpf (i.e., 11-30).
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline to End of Treatment in Mucous Threads Urinalysis Assessment
Clinical safety laboratory mucous threads urinalysis assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline to End of Treatment in Nitrite Urinalysis Assessment
Clinical safety laboratory nitrite urinalysis assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline to End of Treatment in Occult Blood Urinalysis Assessment
Clinical safety laboratory occult blood urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is "negative." An abnormal assessment or worse outcome is a positive assessment (i.e., 2+).
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline to End of Treatment in Protein Urinalysis Assessment
Clinical safety laboratory protein urinalysis assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline to End of Treatment in Specific Gravity Urinalysis Assessment
Clinical safety laboratory specific gravity urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is 1.005-1.030. An abnormal assessment or worse outcome is a value outside of this range.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline to End of Treatment in Specimen Appearance Urinalysis Assessment
Clinical safety laboratory specimen appearance urinalysis assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Urobilinogen Urinalysis Assessment
Clinical safety laboratory urobilinogen urinalysis assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline to End of Treatment in pH Urinalysis Assessment
Clinical safety laboratory pH urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Baseline to End of Treatment in Urine Color Urinalysis Assessment
Clinical safety laboratory urine color urinalysis assessment.
Measured: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Number (%) of Participants Who Did Not Complete The Study Due to Treatment-Emergent Adverse Events
Treatment-emergent adverse events are all adverse events occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period as assessed by CTCAE v4.0.
Measured: Baseline (Day 1) up to Day 26 post-dose, or up to 1 year 3 weeks.
Number (%) of Participants With Adverse Events of Special Interest
An adverse event of special interest is a serious adverse event as defined in Outcome 6. This includes, however is not limited to, increased seizure frequency, new seizure types, worsening of EEG parameters, systemic adverse events based on safety profile as assessed by CTCAE v4.0.
Measured: Baseline (Day 1) up to Day 26 post-dose, or up to 1 year 3 weeks.
Change From Baseline to End of Treatment in Respiration Rate
Measured: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Temperature
Measured: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Baseline Weight
Measured: Baseline (Day 1)
Change From Baseline to End of Treatment in Pulse
The change from baseline to end of treatment in participants' pulses was assessed. The changes in recumbent pulse, standing pulse, and the change from recumbent to standing pulse are reported. Change from recumbent to standing pulse was measured by the difference in recumbent pulse change and standing pulse change.
Measured: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Systolic Blood Pressure
The change from baseline to end of treatment in participants' systolic blood pressure (sbp) was assessed. The changes in recumbent sbp, standing sbp, and the change from recumbent to standing sbp are reported. Change from recumbent to standing sbp was measured by the difference in recumbent sbp change and standing sbp change.
Measured: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Diastolic Blood Pressure
The change from baseline to end of treatment in participants' diastolic blood pressure (dbp) was assessed. The changes in recumbent dbp, standing dbp, and the change from recumbent to standing dbp are reported. Change from recumbent to standing dbp was measured by the difference in recumbent dbp change and standing dbp change.
Measured: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Change From Baseline to End of Treatment in QT Interval
Measured: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Change From Baseline to End of Treatment in QRS Interval
Measured: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Change From Baseline to End of Treatment in PR Interval
Measured: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Heart Rate
Measured: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start25 Feb 2018
- Primary completion29 Mar 2019
- Study completion29 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406702
- Sponsor's protocol ID
- CX-8998-CLN2-002
- Acronym
- T-WAVE
- Status last verified
- Aug 2022
- First submitted
- 2 Jan 2018
- Last updated
- 8 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Safety, Tolerability, Pharmacokinetics, and Quantitative EEG Study of CX-8998 in Adolescents and Adults With Idiopathic Generalized Epilepsy With Absence Seizures
- ClinicalTrials.gov ID
- NCT03406702
- Acronym / sponsor ID
- T-WAVE / CX-8998-CLN2-002
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Idiopathic Generalized Epilepsy, Absence Seizures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2018 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Posted 8 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2a, open-label study consisting of a screening period of up to 4 weeks and a 4-dose-titration treatment period to a dose of up to 10 mg twice daily (BID) of CX-8998, followed by a 1-week safety follow-up period after the last dose of study medication.
Detailed description
This is a Phase 2a, open-label study consisting of a screening period of up to 4 weeks and a 4-dose-titration treatment period to a dose of up to 10 mg twice daily (BID) of CX-8998, followed by a 1-week safety follow-up period after the last dose of study medication.
Subjects will participate for a total of up to 9 weeks, including screening, the 4-week treatment period and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CX-8998 | Experimental | Drug: CX-8998T-type calcium channel blocker |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Signed informed consent form (ICF) indicating that the subject has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.
- Men or non-pregnant, non-breastfeeding women 16 to 55 years-of-age who are able to read and understand written and spoken local language.
- Clinical diagnosis of IGE (including, but not limited to, CAE, JAE, juvenile myoclonic epilepsy, or Jeavons syndrome) with absence seizures consistent with the International League against Epilepsy Revised Classification of Seizures (2017).
- Absence seizures persisting despite standard of care (SOC) treatment, defined as treatment with at least 2 AEDs appropriate for the patient's epilepsy syndrome. SOC failure, per investigator discretion, will be defined as insufficient clinical response or intolerable side effects, which precludes use of the appropriate AED.
- Observation of at least 3 instances of generalized discharges of approximately 2.5 - 4 Hz lasting ≥2 seconds via 24-hour ambulatory EEG (centrally reviewed), with approximately 75% normal background based on age and medication use per the central EEG reader's discretion. Intermittent focal spikes are allowed.
Key exclusion criteria (19 listed)
- History of surgical intervention for treatment of epilepsy.
- Additional seizure (clinical and electrographic) types, including, but not limited to, epileptic spasms, generalized tonic seizures, atonic seizures, or focal seizures. Subjects with GTCS or myoclonic seizures are eligible for the study.
- Inadequately treated psychotic or mood disorder (e.g., schizophrenia, major depression, bipolar disorder).
- Presence of severe intellectual disability, severe autism spectrum disorder, or severe developmental disorder such that the subject cannot sign the ICF or cannot cooperate with the study procedures.
- Presence of positive urine drug screen for drugs of abuse, except if this is explained by use of an allowed prescription medicine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CX-8998T-type calcium channel blocker | Drug | CX-8998 |
Primary outcome
Change From Baseline to End of Treatment in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Fridericia's Correction Formula (QTCF) is a formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates.
Change From Baseline to End of Treatment in Clinical Alanine Aminotransferase Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in alanine aminotransferase serum chemistry concentration.
Change From Baseline to End of Treatment in Clinical Albumin Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in albumin serum chemistry.
Change From Baseline to End of Treatment in Clinical Albumin/Globulin Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in albumin/globulin serum chemistry.
Change From Baseline to End of Treatment in Clinical Alkaline Phosphatase Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in alkaline phosphatase serum chemistry.
Change From Baseline to End of Treatment in Clinical Aspartate Aminotransferase Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in aspartate aminotransferase serum chemistry.
Baseline Clinical Blood Urea Nitrogen/Creatinine Serum Chemistry Concentration
Time frame: Baseline (Day 1)
Clinical safety laboratory assessment in BUN/Creatinine serum chemistry.
Change From Baseline to End of Treatment in Clinical Bilirubin Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in bilirubin serum chemistry.
Change From Baseline to End of Treatment in Clinical Blood Urea Nitrogen Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in blood urea nitrogen serum chemistry.
Change From Baseline to End of Treatment in Clinical Carbon Dioxide Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in carbon dioxide serum chemistry.
Change From Baseline to End of Treatment in Clinical Chloride Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in chloride serum chemistry.
Change From Baseline to End of Treatment in Clinical Calcium Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in calcium serum chemistry.
Change From Baseline to End of Treatment in Clinical Cholesterol Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in cholesterol serum chemistry.
Baseline Clinical Cholesterol/HDL-Cholesterol Serum Chemistry Concentration
Time frame: Baseline (Day 1)
Clinical safety laboratory assessment in cholesterol/HDL-cholesterol serum chemistry.
Change From Baseline to End of Treatment in Clinical Creatine Kinase Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in creatine kinase serum chemistry.
Change From Baseline to End of Treatment in Clinical Creatinine Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in creatinine serum chemistry.
Change From Baseline to End of Treatment in Clinical Globulin Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in globulin serum chemistry.
Baseline Clinical Glomerular Filtration Rate (GFR) Adjusted for Body Surface Area (BSA) Serum Chemistry Concentration
Time frame: Baseline (Day 1)
Clinical safety laboratory assessment in glomerular filtration rate adjusted for BSA chemistry.
Change From Baseline to End of Treatment in Clinical Estimated Glomerular Filtration Rate (GFR) Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in GFR serum chemistry.
Change From Baseline to End of Treatment in Clinical Glucose Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in glucose serum chemistry.
Baseline Clinical HDL Cholesterol Serum Chemistry Concentration
Time frame: Baseline (Day 1)
Clinical safety laboratory assessment in HDL cholesterol serum chemistry.
Baseline Clinical LDL Cholesterol Serum Chemistry Concentration
Time frame: Baseline (Day 1)
Clinical safety laboratory assessment in LDL cholesterol serum chemistry.
Change From Baseline to End of Treatment in Clinical Lactate Dehydrogenase Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in lactate dehydrogenase serum chemistry.
Change From Baseline to End of Treatment in Clinical Magnesium Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in magnesium serum chemistry.
Baseline Clinical Non-HDL Cholesterol Serum Chemistry Concentration
Time frame: Baseline (Day 1)
Clinical safety laboratory assessment in non-HDL cholesterol serum chemistry.
Change From Baseline to End of Treatment in Clinical Phosphate Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in phosphate serum chemistry.
Change From Baseline to End of Treatment in Clinical Potassium Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in potassium serum chemistry.
Change From Baseline to End of Treatment in Clinical Protein Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in protein serum chemistry.
Change From Baseline to End of Treatment in Clinical Sodium Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in sodium serum chemistry.
Change From Baseline to End of Treatment in Clinical Triglycerides Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in triglycerides serum chemistry.
Change From Baseline to End of Treatment in Clinical Urate Serum Chemistry Concentration
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory assessment in urate serum chemistry.
Change From Baseline to End of Treatment in Basophils Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory basophils hematology assessment.
Change From Baseline to End of Treatment in Basophils/Leukocytes Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory basophils/leukocytes hematology assessment.
Change From Baseline to End of Treatment in Eosinophils Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory eosinophils hematology assessment.
Change From Baseline to End of Treatment in Eosinophils/Leukocytes Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory eosinophils/leukocytes hematology assessment.
Change From Baseline to End of Treatment in Mean Corpuscular Hemoglobin (HGB) Concentration Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory mean corpuscular HGB concentration hematology assessment.
Change From Baseline to End of Treatment in Mean Corpuscular Hemoglobin (HGB) Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory mean corpuscular HGB hematology assessment.
Change From Baseline to End of Treatment in Mean Corpuscular Volume Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory mean corpuscular volume hematology assessment.
Change From Baseline to End of Treatment in Erythrocytes Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory erythrocytes hematology assessment.
Change From Baseline to End of Treatment in Erythrocytes Distribution Width Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory erythrocytes distribution width hematology assessment.
Change From Baseline to End of Treatment in Hematocrit Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory hematocrit hematology assessment.
Change From Baseline to End of Treatment in Hemaglobin Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory hemaglobin hematology assessment.
Change From Baseline to End of Treatment in Leukocytes Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory leukocytes hematology assessment.
Change From Baseline to End of Treatment in Lymphocytes Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory lymphocytes hematology assessment.
Change From Baseline to End of Treatment in Lymphocytes/Leukocytes Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory lymphocytes/leukocytes hematology assessment.
Change From Baseline to End of Treatment in Mean Platelet Volume Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory mean platelet volume hematology assessment.
Change From Baseline to End of Treatment in Monocytes Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory monocytes hematology assessment.
Change From Baseline to End of Treatment in Monocytes/Leukocytes Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory monocytes/leukocytes hematology assessment.
Change From Baseline to End of Treatment in Neutrophils Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory neutrophils hematology assessment.
Change From Baseline to End of Treatment in Neutrophils/Leukocytes Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory neutrophils/leukocytes hematology assessment.
Change From Baseline to End of Treatment in Platelets Hematology Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory platelets hematology assessment.
Baseline to End of Treatment in Bacteria Urinalysis Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory bacteria urinalysis assessment.
Baseline to End of Treatment in Urine Bilirubin Urinalysis Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory urine bilirubin urinalysis assessment.
Baseline to End of Treatment in Epithelial Cells Urinalysis Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory epithelial cells urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-10 epithelial cells/high power field (hpf). A worse outcome is >10 epithelial cells.
Baseline to End of Treatment in Urine Erythrocytes Urinalysis Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory urine erythrocytes urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-2 erythrocytes/high power field (hpf). A better outcome is 0 or "none seen."
Baseline to End of Treatment in Urine Glucose Urinalysis Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory urine glucose urinalysis assessment.
Baseline to End of Treatment in Ketones Urinalysis Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory ketones urinalysis assessment.
Baseline to End of Treatment in Leukocyte Esterase Urinalysis Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory leukocyte esterase urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is "negative." An abnormal assessment or worse outcome is a positive assessment (i.e., 2+).
Baseline to End of Treatment in Urine Leukocytes Urinalysis Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory urine leukocytes urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-5 leukocytes/high power field (hpf). An abnormal assessment or worse outcome is >5 leukocytes/hpf (i.e., 11-30).
Baseline to End of Treatment in Mucous Threads Urinalysis Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory mucous threads urinalysis assessment.
Baseline to End of Treatment in Nitrite Urinalysis Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory nitrite urinalysis assessment.
Baseline to End of Treatment in Occult Blood Urinalysis Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory occult blood urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is "negative." An abnormal assessment or worse outcome is a positive assessment (i.e., 2+).
Baseline to End of Treatment in Protein Urinalysis Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory protein urinalysis assessment.
Baseline to End of Treatment in Specific Gravity Urinalysis Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory specific gravity urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is 1.005-1.030. An abnormal assessment or worse outcome is a value outside of this range.
Baseline to End of Treatment in Specimen Appearance Urinalysis Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory specimen appearance urinalysis assessment.
Change From Baseline to End of Treatment in Urobilinogen Urinalysis Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory urobilinogen urinalysis assessment.
Baseline to End of Treatment in pH Urinalysis Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory pH urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed.
Baseline to End of Treatment in Urine Color Urinalysis Assessment
Time frame: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.
Clinical safety laboratory urine color urinalysis assessment.
Number (%) of Participants Who Did Not Complete The Study Due to Treatment-Emergent Adverse Events
Time frame: Baseline (Day 1) up to Day 26 post-dose, or up to 1 year 3 weeks.
Treatment-emergent adverse events are all adverse events occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period as assessed by CTCAE v4.0.
Number (%) of Participants With Adverse Events of Special Interest
Time frame: Baseline (Day 1) up to Day 26 post-dose, or up to 1 year 3 weeks.
An adverse event of special interest is a serious adverse event as defined in Outcome 6. This includes, however is not limited to, increased seizure frequency, new seizure types, worsening of EEG parameters, systemic adverse events based on safety profile as assessed by CTCAE v4.0.
Change From Baseline to End of Treatment in Respiration Rate
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Temperature
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Baseline Weight
Time frame: Baseline (Day 1)
Change From Baseline to End of Treatment in Pulse
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
The change from baseline to end of treatment in participants' pulses was assessed. The changes in recumbent pulse, standing pulse, and the change from recumbent to standing pulse are reported. Change from recumbent to standing pulse was measured by the difference in recumbent pulse change and standing pulse change.
Change From Baseline to End of Treatment in Systolic Blood Pressure
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
The change from baseline to end of treatment in participants' systolic blood pressure (sbp) was assessed. The changes in recumbent sbp, standing sbp, and the change from recumbent to standing sbp are reported. Change from recumbent to standing sbp was measured by the difference in recumbent sbp change and standing sbp change.
Change From Baseline to End of Treatment in Diastolic Blood Pressure
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
The change from baseline to end of treatment in participants' diastolic blood pressure (dbp) was assessed. The changes in recumbent dbp, standing dbp, and the change from recumbent to standing dbp are reported. Change from recumbent to standing dbp was measured by the difference in recumbent dbp change and standing dbp change.
Change From Baseline to End of Treatment in QT Interval
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Change From Baseline to End of Treatment in QRS Interval
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Change From Baseline to End of Treatment in PR Interval
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Change From Baseline to End of Treatment in Heart Rate
Time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CX-8998 in people with Epilepsy, run by Jazz Pharmaceuticals at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to End of Treatment in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) (time frame: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.). The study lists 80 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.