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
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
| Group | Affected | At risk |
|---|---|---|
| Troriluzole | 3 | 292 |
| Placebo | 2 | 289 |
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
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT04693351 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
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.