Study of Levotofisopam 50 mg Three Times a Day (TID) Administered for 7 Days on Hyperuricemia and Gout

Status unconfirmed · Phase 2

Conditions studied: Hyperuricemia, Gout

In brief

The purpose of this study is to determine whether levotofisopam is safe and effective in the treatment of hyperuricemia and gout.

Key facts

Study ID

NCT01519687

Run by

Pharmos

People needed

20

Starts

2012-01-01

Expected to finish

2012-06-01

Last updated by the study team

2012-01-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Duke Clinical Research Unit (DCRU) — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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