drugset / Trial / NCT03299166

Troriluzole (BHV-4157) in Adult Participants With Obsessive Compulsive Disorder

NCT03299166 ↗

Phase 2/3 Completed 426 enrolled Biohaven Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy of troriluzole as adjunctive therapy versus placebo in participants with obsessive compulsive disorder (OCD) who had an inadequate response to selective serotonin reuptake inhibitor (SSRI), clomipramine, venlafaxine, or desvenlafaxine treatment

Timeline

Start
2017-12-19
Primary completion
2020-06-02
Completion
2025-12-08

Outcome

Missed primary endpoint

registry analysis (superiority test); Troriluzole - Randomization Phase vs Placebo - Randomization Phase; p = 0.2202; LS Mean Difference -1.00 (95% CI -2.59 to 0.60); Mixed Models Analysis NCT03299166 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Troriluzole Peptide 200 mg Oral