drugset / Trial / NCT04693351

A Study to Evaluate the Efficacy and Safety of Adjunctive Troriluzole in Obsessive-Compulsive Disorder

NCT04693351 ↗

Phase 3 Completed 589 enrolled Biohaven Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study was to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in participants with Obsessive Compulsive Disorder (OCD).

Timeline

Start
2021-01-29
Primary completion
2025-04-29
Completion
2025-04-29

Outcome

Missed primary endpoint

registry LEAST_SQUARES_MEAN Troriluzole: -3.62 (Standard Error 0.446) score on a scale NCT04693351 ↗

registry LEAST_SQUARES_MEAN Placebo: -4.59 (Standard Error 0.454) score on a scale NCT04693351 ↗

registry analysis (superiority test); Troriluzole vs Placebo; p = 0.041; Least squares mean difference 0.97 (95% CI 0.02 to 1.92) NCT04693351 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Troriluzole Peptide 280 mg Oral