SeizuresPhase 4NCT01721317
Dose-Optimization, Adjunctive Treatment Study of Ezogabine/Retigabine Immediate Release in Partial-onset Seizures
A Phase 4 study testing Ezogabine/Retigabine IR in people with Seizures, run by GlaxoSmithKline at 11 sites in 2 countries.
Trial summary
This is a Phase IV adjunctive treatment dose-optimization study evaluating the efficacy, safety, and health outcomes of ezogabine/retigabine immediate release (IR) (GW582892) compared with placebo in adult subjects with partial-onset seizures (POS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Seizures
- What is being tested?
- Ezogabine/Retigabine IR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 19 Dec 2012to 20 Jun 2013
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A male or female of 18 years of age or above capable of giving written informed consent
- Have a confident diagnosis of epilepsy for >=6 months with partial-onset seizures (POS), i.e., simple or complex POS with or without secondary generalization (classified according to the International League Against Epilepsy (ILAE) Guidelines, prior to the Screening Visit
- Currently receiving monotherapy treatment with an antiepileptic drug (AED) at a stable dose for at least 28 days prior to the screening visit (Visit 1). If the subject is taking a barbiturate (e.g., phenobarbital), the dose must be stable for ≥3 months prior to the Screening Visit. Note: Subjects who have received previous adjunctive treatment but are currently taking one AED are eligible for enrolment.
- Investigator-confirmed partial seizure frequency rate of ≥3 partial seizures per 28 days over the 8 weeks preceding the screening visit and must not have been seizure-free for ≥ 21 consecutive days.
- Female of non-child bearing potential, or female of child-bearing potential willing to use protocol-specified methods of contraception to prevent pregnancy during the study.
- Capable to comply with dosing of study drug, background AED, all study procedures and to maintain an accurate and complete daily written Seizure Calendar and Functional Status Diary
Who cannot join
- Have generalized epilepsy (e.g. Lennox-Gastaut, Juvenile Myoclonic epilepsy, Absence, etc.) or non-epileptic seizures.
- Have had innumerable seizures within the 12-month period prior to the Screening Visit where the individual seizures cannot be counted.
- Have had status epilepticus within 12 months prior to screening
- Have a history of pseudo seizures, non-epileptic events or any other type of psychogenic seizures that could be confused with seizures.
- Have been treated with felbamate or vigabatrin within the 6 months prior to Screening. If a subject has been previously treated with vigabatrin >6 months prior to Screening, a visual perimetry test performed within 6 months prior to Screening must show normal visual fields or no worsening of recognized visual field abnormalities as compared with prior to vigabatrin treatment
- Benzodiazepines used in any manner other than acute usage as defined in this protocol will be considered concurrent AED usage and will not be permitted
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- Are using Central Nervous System (CNS)-active medication (other than concomitant AED therapy), unless the subject has been stabilized on such medication for at least 1 month prior to the Screening Visit.
- Are using herbal treatments with CNS activity within at least 1 month prior to the Screening Visit
- Have received ezogabine/retigabine in a previous study or have taken POTIGA or TROBALT.
- Are currently following or planning to follow the ketogenic diet
- Have an active Vagus Nerve Stimulator (VNS) to control seizures
- Are planning surgery to control seizures during the study
- Have impaired renal function as judged by a creatinine clearance of <50 mL/min
- Have a history of urinary retention or risk factors for urinary retention that in the investigator's judgment could potentially affect subject safety.
- Have an average corrected QT interval (QTc), using Bazett's QT correction (QTcB), ≥450msec or ≥480msec for subjects with bundle branch block at the time of the Screening Visit
- Liver function tests: alanine aminotransferase (ALT) is ≥2 times the upper limit of normal (ULN); alkaline phosphatase and bilirubin are >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%).
- Are suffering from acute or progressive neurological disease, severe psychiatric disease, or severe mental abnormalities that are likely to interfere with the objectives of the study
- Have a history of malignancy within the past 2 years; with the exception of basal cell carcinoma
- Have unstable liver disease [chronic stable hepatitis B and C are acceptable if subject otherwise meets entry criteria; chronic stable Hepatitis B to be excluded if significant immunosuppressive agents administered due to risk of hepatitis B reactivation]
- Have any medical condition that, in the investigator's judgment, is considered to be clinically significant and could potentially affect subject safety or study outcome, including but not limited to: clinically significant cardiac, renal, hepatic condition, or a condition that affects the absorption, distribution, metabolism or excretion of drugs
- Have an active suicidal plan/intent or have had active suicidal thoughts in the past 6 months. Have history of suicide attempt in the last 2 years or more than 1 lifetime suicide attempt.
- Have a history of substance abuse (alcohol or drugs) or substance dependence within 12 months prior to screening
- Have a known hypersensitivity to any components of the study medication
- Have taken an investigational drug, or used an investigational device, within the previous 30 days prior to screening or plans to take an investigational drug anytime during the study.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States9 sites
GSK Investigational Site
Arlington, Texas, 76017
GSK Investigational Site
Bethesda, Maryland, 20817
GSK Investigational Site
Colorado Springs, Colorado, 80907
GSK Investigational Site
Fresno, California, 93710
GSK Investigational Site
Golden Valley, Minnesota, 55422
GSK Investigational Site
Kingwood, Texas, 77339
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Port Charlotte, Florida, 33952
GSK Investigational Site
Santa Monica, California, 90404
Greece2 sites
GSK Investigational Site
Athens, 10676
GSK Investigational Site
Thessaloniki, 57010
About this study
Official title: Study PTG116878, a Dose-Optimization Study of Ezogabine/Retigabine Immediate Release Tablets Versus Placebo in the Adjunctive Treatment of Subjects With Partial-Onset Seizures
This is a Phase IV adjunctive treatment dose-optimization study evaluating the efficacy, safety, and health outcomes of ezogabine/retigabine immediate release (IR) (GW582892) compared with placebo in adult subjects with partial-onset seizures (POS). This randomized, double-blind, placebo-controlled, parallel-group, multicenter study will compare ezogabine/retigabine IR (investigator-selected daily doses of 600 milligram (mg)/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day) with placebo. Study drug will be taken three times a day (TID) in equally or unequally divided doses.
The study design includes up to a 10-week (wk) Screening (≤2 wks)/Baseline (8 wks) Phase, a Titration Phase (2 wks), Dose-Optimization Phase (8 wks), Maintenance Phase (8 wks), and Taper/Follow-Up Phase (3 wks). The total duration of the study for each subject will be approximately 31 wks, and at minimum approximately 27 wks if subjects provide reliable 28-day retrospective seizure data.
Read more
Approximately 280 subjects will be screened with approximately 208 subjects randomly assigned to 1 of 2 treatment groups in a 2:1 ratio (ezogabine/retigabine IR, or placebo).
Subjects will be instructed to start investigational product (IP) the day after the baseline visit. During the first week of the Titration Phase, subjects will be taking 300 mg/day (100 mg TID). During the second week, subjects will be taking 450 mg/day (150 mg/day TID).
At the beginning of the Dose-Optimization Phase (3rd week of study drug) subjects will take 600 mg/day (200 mg TID) for one week. Thereafter during the Dose-Optimization Phase, subjects will continue to increase their daily dose by 150 mg per week until they have achieved their optimal tolerated dose. During this phase, the investigator may choose to have the subject stay on his/her designated dose for another week before attempting a dose increase until reaching a dose of 1200 mg/day. In addition, in the context of tolerability issues, the subject may be reduced to the preceding dose level for one week before attempting to increase the dose again at the next scheduled time point until the subject reaches optimal dose. Subjects unable to tolerate a minimum of 600 mg/day will be discontinued from the study.
The Maintenance Phase will begin at Week 10 (Visit 8) and will last 8 weeks. During the Maintenance Phase, subjects will remain on the daily TID dose achieved at the end of the Dose-Optimization Phase.
Seizure type and frequency will be monitored throughout the study via a Seizure Calendar and will be evaluated at each study visit. Subjects will be instructed to complete the daily Seizure Calendar during each phase of the study.
- Conditions
- Seizures
- Being tested
- Ezogabine/Retigabine IR, Placebo
- Keywords
- Ezogabine/Retigabine, Adjunctive Treatment, Safety, Efficacy, Epilepsy, Tolerability, Immediate Release, GW582892, Dose-Optimization, Partial-Onset Seizures
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezogabine/Retigabine IRDrug
Subjects received drug (dose strength 300 mg to 1200 mg) orally with or without food. The 3 daily doses are to be administered with approximately an 8-hour interval between them.
PlaceboDrug
Matching placebo will be available
| Study group | Role | What they receive |
|---|---|---|
| Titration Phase: Ezogabine/Retigabine 300 mg | Experimental | Subjects receive Ezogabine/Retigabine 300 mg equally divided TID over Wk 1 Receives: Drug: Ezogabine/Retigabine IR |
| Titration Phase: Placebo 300 mg | Placebo comparator | Subjects receive matching Placebo Receives: Drug: Placebo |
| Titration Phase: Ezogabine/Retigabine 450 mg | Experimental | Subjects receive Ezogabine/Retigabine 450 mg equally divided TID over Wk 2 Receives: Drug: Ezogabine/Retigabine IR |
| Titration Phase: Placebo 450 mg | Placebo comparator | Subjects receive matching Placebo Receives: Drug: Placebo |
| Dose-Optimization Phase: Ezogabine/Retigabine 600 mg | Experimental | Subjects receive Ezogabine/Retigabine 600 mg equally divided (200 mg TID) over Wk 3 or until they achieve their optimal tolerated dose as assessed by the Investigator Receives: Drug: Ezogabine/Retigabine IR |
| Dose-Optimization Phase: Placebo 600 mg | Placebo comparator | Subjects receive matching Placebo Receives: Drug: Placebo |
| Dose-Optimization Phase: Ezogabine/Retigabine 750 mg | Experimental | Subjects receive Ezogabine/Retigabine 750 mg equally or unequally divided TID over Wk 4 or until they achieve their optimal tolerated dose as assessed by the Investigator Receives: Drug: Ezogabine/Retigabine IR |
| Dose-Optimization Phase: Placebo 750 mg | Placebo comparator | Subjects receive matching Placebo Receives: Drug: Placebo |
| Dose-Optimization Phase: Ezogabine/Retigabine 900 mg | Experimental | Subjects receive Ezogabine/Retigabine 900 mg equally or unequally divided TID over Wk 5 or until they achieve their optimal tolerated dose as assessed by the Investigator Receives: Drug: Ezogabine/Retigabine IR |
| Dose-Optimization Phase: Placebo 900 mg | Placebo comparator | Subjects receive matching Placebo Receives: Drug: Placebo |
| Dose-Optimization Phase: Ezogabine/Retigabine 1050 mg | Experimental | Subjects receive Ezogabine/Retigabine 1050 mg equally or unequally divided TID over Wk 6 or until they achieve their optimal tolerated dose as assessed by the Investigator Receives: Drug: Ezogabine/Retigabine IR |
| Dose-Optimization Phase: Placebo 1050 mg | Placebo comparator | Subjects receive matching Placebo Receives: Drug: Placebo |
| Dose-Optimization Phase: Ezogabine/Retigabine 1200 mg | Experimental | Subjects receive Ezogabine/Retigabine 1200 mg equally divided (400 mg TID) over Wk 7 or until they achieve their optimal tolerated dose as assessed by the Investigator Receives: Drug: Ezogabine/Retigabine IR |
| Dose-Optimization Phase: Placebo 1200 mg | Placebo comparator | Subjects receive matching Placebo Receives: Drug: Placebo |
| Maintenance Phase:Ezogabine/Retigabine | Experimental | Subjects receive Ezogabine/Retigabine at the daily dose achieved (equally or unequally divided TID) at the end of the Dose-Optimization Phase for 8 Weeks (600 mg, 750 mg, 900 mg, 1050 mg, or 1200 mg) Receives: Drug: Ezogabine/Retigabine IR |
| Maintenance Phase: Placebo | Placebo comparator | Subjects receive matching Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in the 28-day Total Partial Seizure Frequency (POS) From Week 0 (End of Baseline Phase) Through Week 18 (End of Maintenance Phase)
The efficacy of ezogabine/retigabine IR as an adjunctive treatment was to be evaluated by the percent change in the total partial seizure frequency, which was recorded by participants in the daily seizure calendar. The total 28-day POS rate is defined as the total number of POS reported during the evaluation period divided by the total number of applicable days during the evaluation period with this quotient multiplied by 28 days. The applicable days are the days in which the participant had non-missing seizure data (i.e., either 0 or > 0 seizures recorded). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Week 0 (end of Baseline Phase) through Week 18 (end of Maintenance Phase)
Percent Change in the 28-day Total Partial Seizure Frequency (POS) Within Each Stratum From Week 0 (End of Baseline Phase) Through Week 18 (End of Maintenance Phase)
The percent change in 28-day total POS frequency within each stratum (sodium channel blocker or non-sodium channel blocker) background antiepileptic drug (AED) was to be summarized as the supportive analysis. The total 28-day POS value is defined as the total number of POS reported during the evaluation period divided by the total number of applicable days during the evaluation period with this quotient multiplied by 28 days. The applicable days are the days in which the participant had non-missing seizure data (i.e., either 0 or > 0 seizures recorded). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Week 0 (end of Baseline Phase) through Week 18 (end of Maintenance Phase)
Secondary outcomes (29)
Percent Change in 28-day Total Partial Seizure Frequency (POS) for the Indicated Intervals: Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase
The efficacy of ezogabine/retigabine IR as an adjunctive treatment was to be evaluated by the percent change in total partial seizure frequency during the Dose-Optimization Phase and Maintenance Phase. The total 28-day POS value is defined as the total number of POS reported during the evaluation period divided by the total number of applicable days during the evaluation period with this quotient multiplied by 28 days. The applicable days are the days in which the participant had non-missing seizure data (i.e., either 0 or > 0 seizures recorded). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Week 3 (start of Dose -Optimization Phase) to Week 18 (end of Maintenance Phase)
Number of Par. Experiencing >=50% Reduction in 28-day Total Partial Seizure Frequency (POS) for the Intervals: Double-blind Period (Titration Phase + Dose-Optimization Phase + Maintenance Phase), Maintenance Phase and Dose-Optimization + Maintenance Phase
Participants (par.) experiencing >= 50% reduction from Baseline to the end of the Double-Blind Phase in 28-day total POS were to be reported. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Week 0 (end of Baseline Phase) through Week 18 (end of Maintenance Phase)
Number of Seizure Free Participants for the Indicated Intervals: Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase
Participants without seizures during the interval of Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase were to be reported. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Week 3 (start of Dose-Optimization Phase) to Week 18 (end of Maintenance Phase)
Change From Baseline in the Number of Seizure Free Days for the Indicated Intervals: Double-blind Period (Titration Phase + Dose-Optimization Phase + Maintenance Phase), Maintenance Phase and the Dose-Optimization + Maintenance Phase
The change in number of seizure free days during the Double-Blind period, the Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase were to be reported. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Week 0 (end of Baseline Phase) to Week 18 (end of Maintenance Phase)
Percent Change From Baseline in Functional Status (Epilepsy-related Worry and Activity Limitation) and Productivity (Missed Work or School) to the End of the Dose-Optimization Phase and the End of the Maintenance Phase
The effect of ezogabine/retigabine IR as an adjunctive treatment on health outcomes was to be evaluated on the basis of functional status and productivity. Participants were asked to complete the paper functional status diary to collect information to assess how the participant's functional status is affected by their epilepsy symptoms. Participants were asked to rate their epilepsy-related worry, activity limitations, and productivity (missed work or school). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Week 3 (start of Dose -Optimization Phase) to Week 18 (end of Maintenance Phase)
Incidence of New Seizure Types in Participants Without a History of These Seizure Types
The safety and tolerability of ezogabine/retigabine IR was to be evaluated by recording the incidence of new seizure types in participants without a history of these seizure types. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Week 0 (end of Baseline Phase) to Week 21 (end of Taper Phase)
Number of Participants at Each Dose During the Maintenance Phase and Average Maintenance Dose Over All Participants
The safety and tolerability of ezogabine/retigabine IR was to be evaluated by recording the number of participants at each dose during the Maintenance Phase and the average maintenance dose over all participants. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Week 11 (start of Maintenance Phase) to Week 18 (end of Maintenance Phase)
Number of Participants With Early Study Discontinuation
The safety and tolerability of ezogabine/retigabine IR was to be evaluated by recording the incidence of participants with early study discontinuation.
Measured: Week 0 (end of Baseline Phase) to Week 21 (end of Taper Phase)
Change From Baseline in Body Weight
Change from Baseline in body weight was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Change from Baseline in blood pressure was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Heart Rate
Change from Baseline in heart rate was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in the QT Interval Using Bazett's Correction (QTcB) and QT Interval Using Fridericia's Correction (QTcF)
Change from Baseline in the QT interval using Bazett's correction (QTcB) and QT interval using Fridericia's correction were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Segmented Neutrophils and Red Blood Cell (RBC) Distribution Width
The change from Baseline in the indicated hematology tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in the Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Segmented Neutrophils, White Blood Cell (WBC) Count and Platelet Count
The change from Baseline in the indicated hematology tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration
The change from Baseline in the indicated hematology tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Hematocrit
The change from Baseline in the indicated hematology test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Red Blood Cell (RBC) Count
The change from Baseline in the indicated hematology test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Mean Corpuscle Hemoglobin
The change from Baseline in the indicated hematology test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Albumin and Total Protein
The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Lactate Dehydrogenase and Gamma Glutamyltransferase (GGT)
The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Uric Acid and Creatinine
The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Calcium, Chloride, Potassium, Sodium, Glucose, Magnesium, Phosphorus Inorganic, Bicarbonate and Urea/Blood Urea Nitrogen (BUN)
The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in BUN/Creatinine Ratio
The change from Baseline in the indicated chemistry tests was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Creatinine Clearance
The change from Baseline in the indicated chemistry test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Urine Specific Gravity (USG)
The change from Baseline in the indicated urinalysis test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Urine Potential of Hydrogen (pH)
The change from Baseline in the indicated urinalysis test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize ot evaluate this endpoint.
Measured: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick
The change from Baseline in the following urinalysis parameters (urine occult blood, urine glucose, urine ketones and urine protein) were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Post-void Residual (PVR) Urinary Bladder Ultrasound Volume
The change from Baseline in the PVR bladder ultrasound results was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Measured: Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase) and Week 18 (end of Maintenance Phase)
Number of Participants With the Indicated Assessment Events of Suicidal Behavior, Suicidal Ideation or Non-suicidal Self Injurious Behavior Via the Columbia Suicide Severity Rating Scale (C-SSRS)
Prospective assessment of suicidality was conducted using the Columbia-Suicide Severity Rating Scale (C-SSRS), a brief questionnaire designed to assess severity and change in suicidality by integrating both behavior and ideation using a semi-structured interview to probe participant responses. C-SSRS data were only collected through Week 8 for the 6 randomized participants. Due to the study being prematurely terminated, there was not sufficient data to evaluate this endpoint.
Measured: Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 4, Week 6 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2012 (estimated)
- Study start19 Dec 2012
- Primary completion20 Jun 2013
- Study completion20 Jun 2013
Why it stopped: After reevaluation of the benefit: risk profile of ezogabine/retigabine, GSK does not believe the early adjunctive treatment study population is appropriate.
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 SeizuresStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bausch Health Americas, Inc.
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721317
- Sponsor's protocol ID
- 116878
- Other IDs
- 2012-003105-10
- Status last verified
- Dec 2020
- First submitted
- 1 Nov 2012
- Last updated
- 30 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study PTG116878, a Dose-Optimization Study of Ezogabine/Retigabine Immediate Release Tablets Versus Placebo in the Adjunctive Treatment of Subjects With Partial-Onset Seizures
- ClinicalTrials.gov ID
- NCT01721317
- Acronym / sponsor ID
- 116878
- Conditions
- Seizures
- Keywords
- Ezogabine/Retigabine, Adjunctive Treatment, Safety, Efficacy, Epilepsy, Tolerability, Immediate Release, GW582892
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After reevaluation of the benefit: risk profile of ezogabine/retigabine, GSK does not believe the early adjunctive treatment study population is appropriate.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- 19 Dec 2012 (actual)
- Primary completion
- 20 Jun 2013 (actual)
- Study completion
- 20 Jun 2013 (actual)
- First posted
- 5 Nov 2012 (estimated)
- Results
- Posted 26 Mar 2014
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 IV adjunctive treatment dose-optimization study evaluating the efficacy, safety, and health outcomes of ezogabine/retigabine immediate release (IR) (GW582892) compared with placebo in adult subjects with partial-onset seizures (POS). This randomized, double-blind, placebo-controlled, parallel-group, multicenter study will compare ezogabine/retigabine IR (investigator-selected daily doses of 600 milligram (mg)/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day) with placebo. Study drug will be taken three times a day (TID) in equally or unequally divided doses.
The study design includes up to a 10-week (wk) Screening (≤2 wks)/Baseline (8 wks) Phase, a Titration Phase (2 wks), Dose-Optimization Phase (8 wks), Maintenance Phase (8 wks), and Taper/Follow-Up Phase (3 wks). The total duration of the study for each subject will be approximately 31 wks, and at minimum approximately 27 wks if subjects provide reliable 28-day retrospective seizure data.
Approximately 280 subjects will be screened with approximately 208 subjects randomly assigned to 1 of 2 treatment groups in a 2:1 ratio (ezogabine/retigabine IR, or placebo).
Subjects will be instructed to start investigational product (IP) the day after the baseline visit. During the first week of the Titration Phase, subjects will be taking 300 mg/day (100 mg TID). During the second week, subjects will be taking 450 mg/day (150 mg/day TID).
At the beginning of the Dose-Optimization Phase (3rd week of study drug) subjects will take 600 mg/day (200 mg TID) for one week. Thereafter during the Dose-Optimization Phase, subjects will continue to increase their daily dose by 150 mg per week until they have achieved their optimal tolerated dose. During this phase, the investigator may choose to have the subject stay on his/her designated dose for another week before attempting a dose increase until reaching a dose of 1200 mg/day. In addition, in the context of tolerability issues, the subject may be reduced to the preceding dose level for one week before attempting to increase the dose again at the next scheduled time point until the subject reaches optimal dose. Subjects unable to tolerate a minimum of 600 mg/day will be discontinued from the study.
The Maintenance Phase will begin at Week 10 (Visit 8) and will last 8 weeks. During the Maintenance Phase, subjects will remain on the daily TID dose achieved at the end of the Dose-Optimization Phase.
Seizure type and frequency will be monitored throughout the study via a Seizure Calendar and will be evaluated at each study visit. Subjects will be instructed to complete the daily Seizure Calendar during each phase of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Titration Phase: Ezogabine/Retigabine 300 mg | Experimental | Drug: Ezogabine/Retigabine IRSubjects receive Ezogabine/Retigabine 300 mg equally divided TID over Wk 1 |
| Titration Phase: Placebo 300 mg | Placebo comparator | Drug: PlaceboSubjects receive matching Placebo |
| Titration Phase: Ezogabine/Retigabine 450 mg | Experimental | Drug: Ezogabine/Retigabine IRSubjects receive Ezogabine/Retigabine 450 mg equally divided TID over Wk 2 |
| Titration Phase: Placebo 450 mg | Placebo comparator | Drug: PlaceboSubjects receive matching Placebo |
| Dose-Optimization Phase: Ezogabine/Retigabine 600 mg | Experimental | Drug: Ezogabine/Retigabine IRSubjects receive Ezogabine/Retigabine 600 mg equally divided (200 mg TID) over Wk 3 or until they achieve their optimal tolerated dose as assessed by the Investigator |
| Dose-Optimization Phase: Placebo 600 mg | Placebo comparator | Drug: PlaceboSubjects receive matching Placebo |
| Dose-Optimization Phase: Ezogabine/Retigabine 750 mg | Experimental | Drug: Ezogabine/Retigabine IRSubjects receive Ezogabine/Retigabine 750 mg equally or unequally divided TID over Wk 4 or until they achieve their optimal tolerated dose as assessed by the Investigator |
| Dose-Optimization Phase: Placebo 750 mg | Placebo comparator | Drug: PlaceboSubjects receive matching Placebo |
| Dose-Optimization Phase: Ezogabine/Retigabine 900 mg | Experimental | Drug: Ezogabine/Retigabine IRSubjects receive Ezogabine/Retigabine 900 mg equally or unequally divided TID over Wk 5 or until they achieve their optimal tolerated dose as assessed by the Investigator |
| Dose-Optimization Phase: Placebo 900 mg | Placebo comparator | Drug: PlaceboSubjects receive matching Placebo |
| Dose-Optimization Phase: Ezogabine/Retigabine 1050 mg | Experimental | Drug: Ezogabine/Retigabine IRSubjects receive Ezogabine/Retigabine 1050 mg equally or unequally divided TID over Wk 6 or until they achieve their optimal tolerated dose as assessed by the Investigator |
| Dose-Optimization Phase: Placebo 1050 mg | Placebo comparator | Drug: PlaceboSubjects receive matching Placebo |
| Dose-Optimization Phase: Ezogabine/Retigabine 1200 mg | Experimental | Drug: Ezogabine/Retigabine IRSubjects receive Ezogabine/Retigabine 1200 mg equally divided (400 mg TID) over Wk 7 or until they achieve their optimal tolerated dose as assessed by the Investigator |
| Dose-Optimization Phase: Placebo 1200 mg | Placebo comparator | Drug: PlaceboSubjects receive matching Placebo |
| Maintenance Phase:Ezogabine/Retigabine | Experimental | Drug: Ezogabine/Retigabine IRSubjects receive Ezogabine/Retigabine at the daily dose achieved (equally or unequally divided TID) at the end of the Dose-Optimization Phase for 8 Weeks (600 mg, 750 mg, 900 mg, 1050 mg, or 1200 mg) |
| Maintenance Phase: Placebo | Placebo comparator | Drug: PlaceboSubjects receive matching Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A male or female of 18 years of age or above capable of giving written informed consent
- Have a confident diagnosis of epilepsy for >=6 months with partial-onset seizures (POS), i.e., simple or complex POS with or without secondary generalization (classified according to the International League Against Epilepsy (ILAE) Guidelines, prior to the Screening Visit
- Currently receiving monotherapy treatment with an antiepileptic drug (AED) at a stable dose for at least 28 days prior to the screening visit (Visit 1). If the subject is taking a barbiturate (e.g., phenobarbital), the dose must be stable for ≥3 months prior to the Screening Visit. Note: Subjects who have received previous adjunctive treatment but are currently taking one AED are eligible for enrolment.
- Investigator-confirmed partial seizure frequency rate of ≥3 partial seizures per 28 days over the 8 weeks preceding the screening visit and must not have been seizure-free for ≥ 21 consecutive days.
- Female of non-child bearing potential, or female of child-bearing potential willing to use protocol-specified methods of contraception to prevent pregnancy during the study.
Key exclusion criteria (24 listed)
- Have generalized epilepsy (e.g. Lennox-Gastaut, Juvenile Myoclonic epilepsy, Absence, etc.) or non-epileptic seizures.
- Have had innumerable seizures within the 12-month period prior to the Screening Visit where the individual seizures cannot be counted.
- Have had status epilepticus within 12 months prior to screening
- Have a history of pseudo seizures, non-epileptic events or any other type of psychogenic seizures that could be confused with seizures.
- Have been treated with felbamate or vigabatrin within the 6 months prior to Screening. If a subject has been previously treated with vigabatrin >6 months prior to Screening, a visual perimetry test performed within 6 months prior to Screening must show normal visual fields or no worsening of recognized visual field abnormalities as compared with prior to vigabatrin treatment
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 |
|---|---|---|
| Ezogabine/Retigabine IRSubjects received drug (dose strength 300 mg to 1200 mg) orally with or without food. The 3 daily doses are to be administered with approximately an 8-hour interval between them. | Drug | Dose-Optimization Phase: Ezogabine/Retigabine 1050 mg, Dose-Optimization Phase: Ezogabine/Retigabine 1200 mg, Dose-Optimization Phase: Ezogabine/Retigabine 600 mg, Dose-Optimization Phase: Ezogabine/Retigabine 750 mg, Dose-Optimization Phase: Ezogabine/Retigabine 900 mg, Maintenance Phase:Ezogabine/Retigabine, Titration Phase: Ezogabine/Retigabine 300 mg, Titration Phase: Ezogabine/Retigabine 450 mg |
| PlaceboMatching placebo will be available | Drug | Dose-Optimization Phase: Placebo 1050 mg, Dose-Optimization Phase: Placebo 1200 mg, Dose-Optimization Phase: Placebo 600 mg, Dose-Optimization Phase: Placebo 750 mg, Dose-Optimization Phase: Placebo 900 mg, Maintenance Phase: Placebo, Titration Phase: Placebo 300 mg, Titration Phase: Placebo 450 mg |
Primary outcome
Percent Change in the 28-day Total Partial Seizure Frequency (POS) From Week 0 (End of Baseline Phase) Through Week 18 (End of Maintenance Phase)
Time frame: Week 0 (end of Baseline Phase) through Week 18 (end of Maintenance Phase)
The efficacy of ezogabine/retigabine IR as an adjunctive treatment was to be evaluated by the percent change in the total partial seizure frequency, which was recorded by participants in the daily seizure calendar. The total 28-day POS rate is defined as the total number of POS reported during the evaluation period divided by the total number of applicable days during the evaluation period with this quotient multiplied by 28 days. The applicable days are the days in which the participant had non-missing seizure data (i.e., either 0 or > 0 seizures recorded). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
Percent Change in the 28-day Total Partial Seizure Frequency (POS) Within Each Stratum From Week 0 (End of Baseline Phase) Through Week 18 (End of Maintenance Phase)
Time frame: Week 0 (end of Baseline Phase) through Week 18 (end of Maintenance Phase)
The percent change in 28-day total POS frequency within each stratum (sodium channel blocker or non-sodium channel blocker) background antiepileptic drug (AED) was to be summarized as the supportive analysis. The total 28-day POS value is defined as the total number of POS reported during the evaluation period divided by the total number of applicable days during the evaluation period with this quotient multiplied by 28 days. The applicable days are the days in which the participant had non-missing seizure data (i.e., either 0 or > 0 seizures recorded). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.
29 secondary outcomes
Percent Change in 28-day Total Partial Seizure Frequency (POS) for the Indicated Intervals: Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase
Time frame: Week 3 (start of Dose -Optimization Phase) to Week 18 (end of Maintenance Phase)
Number of Par. Experiencing >=50% Reduction in 28-day Total Partial Seizure Frequency (POS) for the Intervals: Double-blind Period (Titration Phase + Dose-Optimization Phase + Maintenance Phase), Maintenance Phase and Dose-Optimization + Maintenance Phase
Time frame: Week 0 (end of Baseline Phase) through Week 18 (end of Maintenance Phase)
Number of Seizure Free Participants for the Indicated Intervals: Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase
Time frame: Week 3 (start of Dose-Optimization Phase) to Week 18 (end of Maintenance Phase)
Change From Baseline in the Number of Seizure Free Days for the Indicated Intervals: Double-blind Period (Titration Phase + Dose-Optimization Phase + Maintenance Phase), Maintenance Phase and the Dose-Optimization + Maintenance Phase
Time frame: Week 0 (end of Baseline Phase) to Week 18 (end of Maintenance Phase)
Percent Change From Baseline in Functional Status (Epilepsy-related Worry and Activity Limitation) and Productivity (Missed Work or School) to the End of the Dose-Optimization Phase and the End of the Maintenance Phase
Time frame: Week 3 (start of Dose -Optimization Phase) to Week 18 (end of Maintenance Phase)
Incidence of New Seizure Types in Participants Without a History of These Seizure Types
Time frame: Week 0 (end of Baseline Phase) to Week 21 (end of Taper Phase)
Number of Participants at Each Dose During the Maintenance Phase and Average Maintenance Dose Over All Participants
Time frame: Week 11 (start of Maintenance Phase) to Week 18 (end of Maintenance Phase)
Number of Participants With Early Study Discontinuation
Time frame: Week 0 (end of Baseline Phase) to Week 21 (end of Taper Phase)
Change From Baseline in Body Weight
Time frame: Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time frame: Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Heart Rate
Time frame: Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in the QT Interval Using Bazett's Correction (QTcB) and QT Interval Using Fridericia's Correction (QTcF)
Time frame: Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Segmented Neutrophils and Red Blood Cell (RBC) Distribution Width
Time frame: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in the Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Segmented Neutrophils, White Blood Cell (WBC) Count and Platelet Count
Time frame: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration
Time frame: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Hematocrit
Time frame: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Red Blood Cell (RBC) Count
Time frame: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Mean Corpuscle Hemoglobin
Time frame: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Albumin and Total Protein
Time frame: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Lactate Dehydrogenase and Gamma Glutamyltransferase (GGT)
Time frame: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Uric Acid and Creatinine
Time frame: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Calcium, Chloride, Potassium, Sodium, Glucose, Magnesium, Phosphorus Inorganic, Bicarbonate and Urea/Blood Urea Nitrogen (BUN)
Time frame: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in BUN/Creatinine Ratio
Time frame: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Creatinine Clearance
Time frame: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Urine Specific Gravity (USG)
Time frame: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Urine Potential of Hydrogen (pH)
Time frame: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick
Time frame: Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)
Change From Baseline in Post-void Residual (PVR) Urinary Bladder Ultrasound Volume
Time frame: Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase) and Week 18 (end of Maintenance Phase)
Number of Participants With the Indicated Assessment Events of Suicidal Behavior, Suicidal Ideation or Non-suicidal Self Injurious Behavior Via the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 4, Week 6 and Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- 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.
GSK Clinical Trials study director
GlaxoSmithKline
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ezogabine/Retigabine IR in people with Seizures, run by GlaxoSmithKline at 11 sites in 2 countries.
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 6 inclusion and 24 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: stopped early, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Greece. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 26 Mar 2014). 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?
Percent Change in the 28-day Total Partial Seizure Frequency (POS) From Week 0 (End of Baseline Phase) Through Week 18 (End of Maintenance Phase) (time frame: Week 0 (end of Baseline Phase) through Week 18 (end of Maintenance Phase)). The study lists 2 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 30 Dec 2020.