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Real-World Data Study of Troriluzole-Treated Patients With Spinocerebellar Ataxia (SCA) Compared to a Matched Natural History Control

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Study completion pushed from Jun 2026 to Aug 2026v5
  2. Study completion date: Jan 2026 to Jun 2026v4
  3. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 1000 to confirmed 909
    • Primary completion date changed from estimate of Sep 2024 to Sep 6, 2024
    v3
  4. Primary endpoint revised
    • Secondary endpoints expanded, about 330 words
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to leverage two sources of real-world data (RWD) to assess the effectiveness of troriluzole after three years of treatment in patients with SCA by comparison to an external control of untreated patients who were followed in a natural history cohort. Real world evidence of effectiveness will be assessed from the RWD sources to examine the treatment effects of toriluzole in SCA out to 3 years. Progression rates of SCA differ by genotype and long-term follow-up is needed to assess for potential efficacy in this rare disease.
Trial Details
NCT Number NCT06529146
Lead Sponsor Biohaven Therapeutics Ltd.
Conditions
(from sponsor)		 Spinocerebellar Ataxias
Related terms Spinocerebellar Ataxias
Enrollment 909 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov