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Trial in Adult Participants With Spinocerebellar Ataxia (SCA)

NCT02960893Phase 2/3Completed

Lead sponsor
Biohaven Pharmaceuticals, Inc. (Industry)
Enrollment
141 (actual)
Start date
15 Dec 2016
Primary completion
18 Aug 2017 (actual)
Study completion
20 Sep 2024
Last update posted
8 Oct 2025

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Quadruple
Arms
4

Interventions

  • Troriluzole Drug
  • Placebo Drug

Conditions and primary outcome

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

Primary outcome

Change From Baseline in Total Score on the Scale for the Assessment and Rating of Ataxia (SARA) at Randomization Phase Week 8 (Baseline, Randomization Phase Week 8)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT02960893 (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. Change From Baseline in Total Score on the Scale for the Assessment and Rating of Ataxia (SARA) at Randomization Phase Week 8

    Time frame
    Baseline, Randomization Phase Week 8
    Measure
    Mean
    Unit
    score on a scale

    • Troriluzole - Randomization Phase vs Placebo - Randomization PhaseSuperiority

      Estimate
      0.2LS Mean
      95% CI, two-sided
      -0.5 to 0.9
      p-value
      0.519
      Method
      Mixed Model with Repeated Measures

Serious adverse events

Time frame: From first dose of study drug to 30 days post the last dose in the OLE Phase (Up to 348 weeks after last randomization participant was enrolled)

Participants with serious adverse events per group for NCT02960893, as posted
GroupAffectedAt risk
Troriluzole - Randomization Phase471
Placebo - Randomization Phase170
Troriluzole/Troriluzole - OLE Phase1164
Placebo/Troriluzole - OLE Phase967

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

1 on PubMed

  1. 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.