HyperuricemiaPhase 2NCT01519687
Study of Levotofisopam 50 mg Three Times a Day (TID) Administered for 7 Days on Hyperuricemia and Gout
A Phase 2 study testing levotofisopam in people with Hyperuricemia and Gout, run by Pharmos at 1 site in United States.
Trial summary
The purpose of this study is to determine whether levotofisopam is safe and effective in the treatment of hyperuricemia and gout. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperuricemia, Gout
- What is being tested?
- levotofisopam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide voluntary, signed informed consent.
- Male or postmenopausal or surgically sterile females, 18 to 65 years of age, inclusive. Female participants must have been amenorrheic for a minimum of 12 months and must have a negative pregnancy test result within 3 days before administration of levotofisopam. Surgically sterile females are defined as those who have had a hysterectomy, bilateral ovariectomy, or bilateral tubal ligation. Male subjects must agree to practice a medically acceptable form of contraception for the duration of the study and for 30 days after receiving the last dose of levotofisopam.
- Physician diagnosis of gout with at least one gout flare in the last 6 months, at least one chronically swollen joint due to gout, or presence of a tophus.
- Serum urate level ≥ 8.0 mg/dL and ≤ 12.0 mg/dL after having stopped all urate-lowering therapy for at least 10 days. Serum urate level must also be > 7.7 mg/dL and ≤ 12.0 mg/dL on Day -3 and on Day -2.
- Willing and able to discontinue urate-lowering therapy starting at the screening visit (14-21 days before receiving study drug) through to the follow-up visit (up to 10 days after discharge from the study unit), for a total time off urate-lowering therapy of up to approximately 5 weeks.
- In the opinion of the investigator, able to participate in all scheduled evaluations, likely to complete all required tests, and likely to be compliant.
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- Medications permitted for the treatment of non-excluded medical conditions (other than gout) must be at stable doses for at least 14 days prior to baseline.
- Permitted concurrent general medical conditions must be stable and well controlled.
- Written and oral fluency in the English language.
Who cannot join
- Previous treatment with racemic tofisopam (RS-tofisopam), levotofisopam (S-tofisopam), or dextofisopam (R-tofisopam).
- Known or suspected hypersensitivity to any benzodiazepine.
- History of two or more clinically significant drug allergies.
- Clinically significant infection within 30 days prior to screening or between screen and admission.
- History or presence of clinically significant medical disease that might compromise the study or be detrimental to the patient, such as hepatitis (patient excluded if hepatitis A was present within 2 years before screening or if there is any history of hepatitis B or C), human immunodeficiency virus (HIV) infection, uncontrolled diabetes mellitus, cirrhosis, active biliary disease (bile ducts or gallbladder), or moderate or severe chronic kidney disease (estimated glomerular filtration rate < 60 mL/min/1.73 m2).
- Presence of a gout flare during screening or the procedure window.
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- History or presence of nephrolithiasis.
- History or presence of malignancy other than localized basal cell cancer, squamous cell skin cancer, or cancer in situ that has been resected within 5 years.
- Clinically significant head trauma with loss of consciousness within 10 years prior to screen.
- Myocardial infarction, congestive heart failure, or known coronary artery disease within 5 years prior to screen.
- Any history of cerebrovascular accident.
- History of seizure disorder other than a single childhood febrile seizure.
- Alcohol or psychoactive substance abuse or dependence, as defined by DSM-IV, within 1 year prior to screen, or alcohol use exceeding 21 units per week (on average) in the 3 months preceding screen.
- Used any tobacco- or nicotine-containing product more days than not within 30 days prior to screening or between screen and admission.
- Regular consumption (e.g., more days than not) of excessive quantities of caffeine-containing beverages (e.g., more than eight cups of coffee or equivalent per day) within 30 days prior to screening or between screen and admission.
- History of suicide attempt, any suicidal behavior within 6 months prior to screening or between screen and baseline, or, in the opinion of the investigator, clinically significant risk of suicide or violent behavior.
- History or presence of a clinically significant psychiatric disorder or symptom (e.g., delusions, hallucinations) that is likely to compromise the study (e.g., confound study results) or be detrimental to the patient.
- History of difficulty donating blood, or history or presence of clinically significant bleeding or hemorrhagic tendencies.
- Donation of blood or plasma within 90 days prior to screening or between screening and admission.
- Uncontrolled hypertension (systolic blood pressure > 160 mmHg and/or diastolic > 95 mmHg) or heart rate either < 50 BPM or > 100 BPM at any evaluation prior to the first dose of test drug.
- Pregnancy, lactation, a positive pregnancy test result during the screening or admission evaluation.
- A clinically significant abnormality on the screening physical examination, 12-lead electrocardiogram (ECG), or laboratory evaluations.
- A corrected QT (QTcF) value > 450 msec (males) or > 470 msec (females) at screening, admission (Day -3), or baseline (Day -1).
- Aspartate aminotransferase or alanine aminotransferase levels > 2 times upper limit of normal (ULN), alkaline phosphatase > 1.5 times ULN, creatinine outside the limits of normal, triglycerides > 500 mg/dL, or thyroid-stimulating hormone (TSH) levels greater than 6.0 µIU/L at screening, admission (Day -3), or Day -2.
- A finding of opiates, amphetamines, cocaine, cannabis, or phencyclidine on the urine drug screen (UDS). Any other positive UDS result must be discussed by the investigator and medical monitor prior to potentially allowing participation of the subject in the study.
- A positive HIV, hepatitis B, or hepatitis C test.
- Inability to take or tolerate colchicine for gout flare prophylaxis (0.6 mg QD or BID).
- Required use of any of the following from the screening visit through the follow-up visit: aspirin or other nonsteroidal antiinflammatory drugs (other than paracetamol, as noted below), diuretics, medications with known urate-lowering effects (including, but not limited to, fenofibrate, losartan, or vitamin C > 500 mg/day), or urate-lowering therapy other than levotofisopam.
- Dietary requirements inconsistent with the study unit's standardized diet.
- Body mass index ≥ 35.
- Use of any investigational treatment within 30 days prior to screening or between screen and admission.
- Use of any psychopharmacologic drug or substance within 7 days of screening or between screen and admission.
- Use of potent CYP3A4 inhibitors or potent CYP3A4 inducers within 7 days prior to screening or between screen and admission.
- An estimated 24-hour uric acid excretion > 1,000 mg/day.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Duke Clinical Research Unit (DCRU)
Durham, North Carolina, 27720
John S. Sundy, MD, PhD, 919-684-2347, john.sundy@duke.edu
Lou Cappoli, (919) 684-4888, lou.cappoli@duke.edu
About this study
Official title: Open-Label, Inpatient Study of Levotofisopam 50 mg TID Administered for 7 Days to Men and Postmenopausal Women With Hyperuricemia and Gout
The purpose of this study is to determine whether levotofisopam is safe and effective in the treatment of hyperuricemia and gout.
Read the detailed description
The primary objectives of this study are (1) to evaluate the safety and tolerability of levotofisopam in patients with hyperuricemia and gout, and (2) to evaluate the effect of treatment with levotofisopam on serum urate levels in these patients.
- Conditions
- Hyperuricemia, Gout
- Being tested
- levotofisopam
- Keywords
- hyperuricemia, gout, levotofisopam
- Medical subject headings
- Hyperuricemia, Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levotofisopamDrug
Also called S-tofisopam
50 mg on Day 1, 50 mg TID on Days 2 through 6, and a single dose of 50 mg on Day 7
| Study group | Role | What they receive |
|---|---|---|
| Levotofisopam | Experimental | All patients will receive a single dose of 50 mg on Day 1, 50 mg three times a day (TID) on Days 2 through 6, and a single dose of 50 mg on Day 7. Each dose of study drug will be administered by authorized site personnel throughout the 7-day inpatient treatment period. Receives: Drug: levotofisopam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction in serum urate
The primary efficacy variable is the percentage reduction in serum urate from baseline to Day 7 on treatment with levotofisopam.
Measured: Days 1-7
Secondary outcomes (1)
Absolute reduction in serum urate from baseline
Secondary efficacy variables include absolute reduction in serum urate from baseline to Day 7 on treatment with levotofisopam, proportion of subjects with serum urate < 6 mg/dL on Day 7, change in fractional excretion of urate from baseline to Day 6, and change in 24-hour urinary uric acid from baseline to Day 6.
Measured: Days 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmos
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John S. Sundy, MD, PhD, Principal investigator, Duke Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519687
- Sponsor's protocol ID
- PRS-TOFS-G201
- Status last verified
- Jan 2012
- First submitted
- 24 Jan 2012
- Last updated
- 27 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Inpatient Study of Levotofisopam 50 mg TID Administered for 7 Days to Men and Postmenopausal Women With Hyperuricemia and Gout
- ClinicalTrials.gov ID
- NCT01519687
- Acronym / sponsor ID
- PRS-TOFS-G201
- Conditions
- Hyperuricemia, Gout
- Keywords
- hyperuricemia, gout, levotofisopam
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- PharmosIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 27 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether levotofisopam is safe and effective in the treatment of hyperuricemia and gout.
Detailed description
The primary objectives of this study are (1) to evaluate the safety and tolerability of levotofisopam in patients with hyperuricemia and gout, and (2) to evaluate the effect of treatment with levotofisopam on serum urate levels in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levotofisopam | Experimental | Drug: levotofisopamAll patients will receive a single dose of 50 mg on Day 1, 50 mg three times a day (TID) on Days 2 through 6, and a single dose of 50 mg on Day 7. Each dose of study drug will be administered by authorized site personnel throughout the 7-day inpatient treatment period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provide voluntary, signed informed consent.
- Male or postmenopausal or surgically sterile females, 18 to 65 years of age, inclusive. Female participants must have been amenorrheic for a minimum of 12 months and must have a negative pregnancy test result within 3 days before administration of levotofisopam. Surgically sterile females are defined as those who have had a hysterectomy, bilateral ovariectomy, or bilateral tubal ligation. Male subjects must agree to practice a medically acceptable form of contraception for the duration of the study and for 30 days after receiving the last dose of levotofisopam.
- Physician diagnosis of gout with at least one gout flare in the last 6 months, at least one chronically swollen joint due to gout, or presence of a tophus.
- Serum urate level ≥ 8.0 mg/dL and ≤ 12.0 mg/dL after having stopped all urate-lowering therapy for at least 10 days. Serum urate level must also be > 7.7 mg/dL and ≤ 12.0 mg/dL on Day -3 and on Day -2.
- Willing and able to discontinue urate-lowering therapy starting at the screening visit (14-21 days before receiving study drug) through to the follow-up visit (up to 10 days after discharge from the study unit), for a total time off urate-lowering therapy of up to approximately 5 weeks.
Key exclusion criteria (34 listed)
- Previous treatment with racemic tofisopam (RS-tofisopam), levotofisopam (S-tofisopam), or dextofisopam (R-tofisopam).
- Known or suspected hypersensitivity to any benzodiazepine.
- History of two or more clinically significant drug allergies.
- Clinically significant infection within 30 days prior to screening or between screen and admission.
- History or presence of clinically significant medical disease that might compromise the study or be detrimental to the patient, such as hepatitis (patient excluded if hepatitis A was present within 2 years before screening or if there is any history of hepatitis B or C), human immunodeficiency virus (HIV) infection, uncontrolled diabetes mellitus, cirrhosis, active biliary disease (bile ducts or gallbladder), or moderate or severe chronic kidney disease (estimated glomerular filtration rate < 60 mL/min/1.73 m2).
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 |
|---|---|---|
| levotofisopamAlso: S-tofisopam50 mg on Day 1, 50 mg TID on Days 2 through 6, and a single dose of 50 mg on Day 7 | Drug | Levotofisopam |
Primary outcome
Percentage reduction in serum urate
Time frame: Days 1-7
The primary efficacy variable is the percentage reduction in serum urate from baseline to Day 7 on treatment with levotofisopam.
1 secondary outcome
Absolute reduction in serum urate from baseline
Time frame: Days 1-7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2012.
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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.
John S. Sundy, MD, PhD principal investigator
Duke Clinical Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing levotofisopam in people with Hyperuricemia and Gout, run by Pharmos at 1 site 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 9 inclusion and 34 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: status not confirmed, as of the sponsor's last update on 27 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John S. Sundy, MD, PhD ((919) 684-2347, john.sundy@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage reduction in serum urate (time frame: Days 1-7). 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 27 Jan 2012.