Trials / Completed

CompletedNCT02960893

Trial in Adult Participants With Spinocerebellar Ataxia (SCA)

A Phase IIb/III, Randomized, Double-blind, Placebo-controlled Trial of Troriluzole in Adult Participants With Spinocerebellar Ataxia

Status: Completed
Phase: Phase 2 / Phase 3
Study type: Interventional
Enrollment: 141 (actual)

Sponsor: Biohaven Pharmaceuticals, Inc. · Industry
Sex: All
Age: 18 Years – 75 Years
Healthy volunteers: Not accepted

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).

Detailed description

The study was conducted in 2 phases: Randomization Phase (8 weeks) followed by an open-label Extension Phase (336 weeks). During the Randomization Phase, participants received either Troriluzole 140 mg or matching placebo up to 8 weeks. Participants who agreed to enter the Open-label Extension Phase continued dosing of Troriluzole 140 mg for 336 weeks. The study was subsequently amended to follow participants for a total of 336 weeks in the Open-label Extension Phase.

Conditions

Interventions

Type	Name	Description
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).

Timeline

Start date: 2016-12-15
Primary completion: 2017-08-18
Completion: 2024-09-20
First posted: 2016-11-10
Last updated: 2025-10-08
Results posted: 2020-08-14

Locations

18 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT02960893. Inclusion in this directory is not an endorsement.