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

NCT04693351Phase 3Completed

Lead sponsor
Biohaven Pharmaceuticals, Inc. (Industry)
Enrollment
589 (actual)
Start date
29 Jan 2021
Primary completion
29 Apr 2025 (actual)
Study completion
29 Apr 2025
Last update posted
22 May 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 Y-BOCS Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8 (Negative Change Indicates Symptom Improvement) (Baseline and Week 8)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT04693351 (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 Y-BOCS Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8 (Negative Change Indicates Symptom Improvement)

    Time frame
    Baseline and Week 8
    Measure
    Least squares mean
    Unit
    score on a scale
    • Troriluzole vs PlaceboSuperiority

      Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, geographic region, current SOC Medication stratification, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates and participant as random effect. An unstructured covariance matrix with degrees of freedom using Kenward-Roger approximation was used.

      Estimate
      0.97Least squares mean difference
      95% CI, two-sided
      0.02 to 1.92
      p-value
      0.041
      Method
      Mixed Models Analysis

Serious adverse events

Time frame: For Adverse Events: From first dose up to approximately 12 weeks For All-cause Mortality: From Day 1 up to approximately 12 weeks

Participants with serious adverse events per group for NCT04693351, as posted
GroupAffectedAt risk
Troriluzole3292
Placebo2289

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 NCT04693351.

CT-VCA trial quality

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Data integrity

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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.