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

NCT03299166Phase 2/3Completed

Lead sponsor
Biohaven Pharmaceuticals, Inc. (Industry)
Enrollment
426 (actual)
Start date
19 Dec 2017
Primary completion
2 Jun 2020 (actual)
Study completion
8 Dec 2025
Last update posted
22 Jan 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Quadruple
Arms
2

Interventions

  • Troriluzole Drug
  • Placebo Drug

Conditions and primary outcome

  • Obsessive-Compulsive Disorder

Primary outcome

Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score (Baseline, Week 12)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT03299166 (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 the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score

    Time frame
    Baseline, Week 12
    Measure
    Least squares mean
    Unit
    Scores on a scale
    • Troriluzole - Randomization Phase vs Placebo - Randomization PhaseSuperiority

      Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect.

      Estimate
      -1.00LS Mean Difference
      95% CI, two-sided
      -2.59 to 0.60
      p-value
      0.2202
      Method
      Mixed Models Analysis

Serious adverse events

Time frame: Randomization Phase: Maximum duration: 12 weeks

Participants with serious adverse events per group for NCT03299166, as posted
GroupAffectedAt risk
Troriluzole - Randomization Phase0122
Placebo - Randomization Phase0122

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

No PubMed citation lists NCT03299166.

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.