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Open Pilot Trial of BHV-4157

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 9, 2024 (before its estimated December 15, 2024 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Apr 2024 to Dec 15, 2024
    • Study completion date: Sep 2024 to Dec 15, 2024
    v6
  2. Primary completion date: Apr 2021 to Apr 2024
    • Study completion date: Sep 2021 to Sep 2024
    • Study title shortened, about 1 word
    v5
  3. Primary completion date: Jul 2019 to Apr 2021
    • Study completion date: Jul 2020 to Sep 2021
    v4
  4. Primary completion date: May 2018 to Jul 2019
    • Study completion date: Jan 2019 to Jul 2020
    v3
  5. Primary endpoint revised
    • Secondary endpoints revised (4)
    • Study title shortened, about 6 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03408080
Lead Sponsor University of California, Los Angeles
Conditions
(from sponsor)		 Spinocerebellar Ataxias, Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2, Spinocerebellar Ataxia 3, Spinocerebellar Ataxia Type 6, MSA-C
Related terms Machado-Joseph Disease, Spinocerebellar Ataxias
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov