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Trial in Adult Participants With Spinocerebellar Ataxia (SCA)

NCT02960893 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2025-10-08

Study results available
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Summary

The primary purpose of this study was to compare the efficacy of BHV-4157 (Troriluzole) 140 milligrams (mg) once daily versus placebo after 8 weeks of treatment in participants with spinocerebellar ataxia (SCA).

Conditions

  • 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

Interventions

DRUG

Troriluzole

Randomization Phase: Neat (i.e., drug substance without excipients); loose filled capsule.

DRUG

Placebo

Drug: Placebo Randomization Phase: Matching placebo loose filled capsule.

DRUG

Troriluzole

OLE phase: Neat capsule or formulated capsule (i.e., drug substance with excipients).

Sponsors & Collaborators

  • Biohaven Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-15
Primary Completion
2017-08-18
Completion
2024-09-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02960893 on ClinicalTrials.gov