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Troriluzole in Adult Participants With Spinocerebellar Ataxia

NCT03701399Phase 3Active, not recruiting

Lead sponsor
Biohaven Pharmaceuticals, Inc. (Industry)
Enrollment
299 (actual)
Start date
8 Mar 2019
Primary completion
18 Feb 2022 (actual)
Study completion
1 Aug 2026
Last update posted
24 Jun 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Quadruple
Arms
2

Interventions

  • troriluzole Drug
  • Placebo Drug

Conditions and primary outcome

  • Spinocerebellar Ataxias
  • Spinocerebellar Ataxia Type 1
  • Spinocerebellar Ataxia Type 2
  • Spinocerebellar Ataxia Type 3
  • Spinocerebellar Ataxia Type 6
  • Spinocerebellar Ataxia Type 7
  • Spinocerebellar Ataxia Type 8
  • Spinocerebellar Ataxia Type 10

Primary outcome

Randomization Phase: Change From Baseline in the Modified Functional Scale for the Assessment and Rating of Ataxia (f-SARA) Total Score at Week 48 in SCA Participants (Randomization Baseline; Week 48)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT03701399 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Randomization Phase: Change From Baseline in the Modified Functional Scale for the Assessment and Rating of Ataxia (f-SARA) Total Score at Week 48 in SCA Participants

    Time frame
    Randomization Baseline; Week 48
    Measure
    Least squares mean
    Unit
    score on a scale

    • Troriluzole vs PlaceboSuperiority

      All SCA participants

      Estimate
      -0.06Least squares mean difference
      95% CI, two-sided
      -0.47 to 0.34
      p-value
      0.7581
      Method
      Mixed Models Analysis

    • Troriluzole vs PlaceboSuperiority

      SCA3 genotype participants

      Estimate
      -0.56Least square mean difference
      95% CI, two-sided
      -1.11 to -0.01
      p-value
      0.0450
      Method
      Mixed Models Analysis

Serious adverse events

Time frame: For Adverse events (AEs): From first dose of study drug up to Week 48 plus 30 days (maximum duration: 52 weeks) For All-cause mortality: From randomization up to Week 48 plus 30 days (maximum duration: 52 weeks)

Participants with serious adverse events per group for NCT03701399, as posted
GroupAffectedAt risk
Troriluzole6108
Placebo8109

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

3 on PubMed

  1. Measurement Properties of the Friedreich Ataxia Rating Scale in Patients with Spinocerebellar Ataxia.

    Neurology and therapy · 2025 Apr

    PubMed 39806095 (opens in a new tab)DOI 10.1007/s40120-024-00708-4 (opens in a new tab)

  2. Video-Based Kinematic Analysis of Movement Quality in a Phase 3 Clinical Trial of Troriluzole in Adults with Spinocerebellar Ataxia: A Post Hoc Analysis.

    Neurology and therapy · 2024 Aug

    PubMed 38814532 (opens in a new tab)DOI 10.1007/s40120-024-00625-6 (opens in a new tab)

  3. Development and Validation of a Patient-Reported Outcome Measure of Ataxia.

    Movement disorders : official journal of the Movement Disorder Society · 2021 Oct

    PubMed 34115419 (opens in a new tab)DOI 10.1002/mds.28670 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.