Open Pilot Trial of BHV-4157 (NCT03408080) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Open Pilot Trial of BHV-4157
United States24 participantsStarted 2017-12-15
Plain-language summary
24 adults, between the ages of 18 and 75 years, with cerebellar ataxia will be enrolled in a 12 week trial of BHV-4157 for treatment of ataxia. BHV-4157 is a pro-drug of riluzole (which is currently FDA-approved for ALS, Lou Gehrig's disease). There will be 5 visits to UCLA required--Screening when general and neurological examination, blood and urine testing, ECG, and questionnaires will be administered; Baseline when general and neurological examination and questionnaires will be administered and study drug dispensed; Week 4 and Week 12 when general and neurological examination, blood and urine testing, ECG, and questionnaires will be administered; 2 weeks after finishing study drug when general examination and blood testing will be completed. There is an option for a 36 week extension of the study drug trial.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Informed Consent a. Subjects (or legally acceptable representative as required by the IRB/IEC) must provide a written signed informed consent form/forms (IRB/EC specific) prior to the initiation of any protocol required procedures.
✓. Age and Sex a. Male and female outpatient subjects between the ages of 18 - 75, inclusive
✓. Target Populations
Exclusion criteria
✕. Target Disease Exceptions
✕. Medical History Exclusions
✕. Physical and Laboratory Test Findings
✕. Prohibited Treatments and/or Therapies
✕. History of not tolerating treatment with riluzole for any reason
✕. Treatment with riluzole in the 30 days prior to screening and/or during the study; \[with the exception of the switch group of SCA subjects\].