Evaluating the effectiveness of troriluzole for treating obsessive-compulsive disorder
A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder
This study is testing if adding a new medication called troriluzole can help people with obsessive-compulsive disorder who haven't had enough improvement from their current treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Biohaven Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 96 sites (Chandler, Arizona and 95 other locations) |
| Trial ID | NCT04641143 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy and safety of troriluzole as an additional treatment for patients with obsessive-compulsive disorder (OCD) who have not responded adequately to standard medications. Participants will receive either troriluzole or a placebo while their symptoms are monitored over the course of the trial. The study will include individuals diagnosed with OCD for at least one year and who have shown minimal improvement with current treatments. The goal is to determine if adding troriluzole can provide better outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with obsessive-compulsive disorder for at least one year and who have not experienced sufficient relief from standard medications.
Not a fit: Patients who have not been diagnosed with obsessive-compulsive disorder or those who have not tried standard treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from OCD who have not responded to existing therapies.
How similar studies have performed: While there have been studies on various treatments for OCD, the specific use of troriluzole as an adjunctive therapy is relatively novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the MINI at Screening; The duration of the subject's illness must be ≥ 1 year 2. An inadequate response to current Standard of Care medication defined as selective serotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at an adequate and stable dose for at least 8 weeks prior to screening and at least 12 weeks at baseline (adequate dose defined by USPI labeling); an inadequate response as defined per the MGH-TRQ-OCD, there has been minimal or no meaningful clinical benefit as perceived by the subject 3. Determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Subjects must be physically able and expected to complete the trial as designed Exclusion Criteria: 1. Subjects with a history of more than two (2) previous failed or inadequate treatment classes given for an adequate duration at an adequate dose as defined by the MGH-TRQ-OCD. 2. Current or prior history of: bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, antisocial personality disorder, Tourette's disorder, body dysmorphic disorder, hoarding disorder; or psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT); or general medical condition that may confound safety and/or efficacy results 3. Previous treatment in a study with troriluzole
Where this trial is running
Chandler, Arizona and 95 other locations
- Metropolitan Neuro Behavioral Institute — Chandler, Arizona, United States (Completed)
- IMA Clinical Research — Phoenix, Arizona, United States (Recruiting)
- NoeisisPharma, LLC — Phoenix, Arizona, United States (Recruiting)
- Atria Clinical Research — Little Rock, Arkansas, United States (Withdrawn)
- Advanced Research Center, Inc. — Anaheim, California, United States (Withdrawn)
- CITrials (Clinical Innovations) — Bellflower, California, United States (Completed)
- Axiom Research, LLC — Colton, California, United States (Active_not_recruiting)
- Global Clinical Trials — Costa Mesa, California, United States (Withdrawn)
- WR-PRI, LLC (Encino) — Encino, California, United States (Recruiting)
- Behavioral Research Specialists, LLC — Glendale, California, United States (Recruiting)
- Synergy Research San Diego — Lemon Grove, California, United States (Withdrawn)
- Pharmacology Research Institute — Los Alamitos, California, United States (Active_not_recruiting)
- Clarity Clinical Research — Los Angeles, California, United States (Recruiting)
- Pharmacology Research Institute (WR-PRI, LLC) — Newport Beach, California, United States (Withdrawn)
- Pacific Research Partners — Oakland, California, United States (Withdrawn)
- Excell Research, Inc — Oceanside, California, United States (Recruiting)
- NRC Research Institute — Orange, California, United States (Recruiting)
- Anderson Clinical Research — Redlands, California, United States (Active_not_recruiting)
- ACRC Studies — San Diego, California, United States (Withdrawn)
- Lumos Clinical Research Center, LLC — San Jose, California, United States (Recruiting)
- California Neuroscience Research Medical Group, Inc — Sherman Oaks, California, United States (Recruiting)
- Stanford University — Stanford, California, United States (Recruiting)
- Collaborative Neuroscience Research — Torrance, California, United States (Active_not_recruiting)
- Yale University / Connecticut Mental Health Center — New Haven, Connecticut, United States (Recruiting)
- Coastal Connecticut Research, LLC — New London, Connecticut, United States (Withdrawn)
- Comprehensive Psychiatric Care — Norwich, Connecticut, United States (Recruiting)
- Boca Raton Medical Institute — Boca Raton, Florida, United States (Completed)
- Advanced Clinical Research Network — Coral Gables, Florida, United States (Completed)
- Research in Miami Inc — Hialeah, Florida, United States (Active_not_recruiting)
- Galiz Research — Hialeah, Florida, United States (Withdrawn)
- Accel Research Sites — Lakeland, Florida, United States (Completed)
- Innovative Clinical Research, Inc. — Lauderhill, Florida, United States (Completed)
- ClinCloud, LLC — Maitland, Florida, United States (Withdrawn)
- Pro-Care Research Center — Miami Gardens, Florida, United States (Withdrawn)
- South Florida Research Phase I-IV , Inc. — Miami Springs, Florida, United States (Recruiting)
- Health Care Family Rehab & Research — Miami, Florida, United States (Active_not_recruiting)
- Central Miami Medical Institute — Miami, Florida, United States (Recruiting)
- Sanchez Clinical Research Inc — Miami, Florida, United States (Withdrawn)
- Firc — Miami, Florida, United States (Active_not_recruiting)
- Florida Research Center, Inc. — Miami, Florida, United States (Recruiting)
- Bayside Clinical Research, LLC — New Port Richey, Florida, United States (Withdrawn)
- Behavioral Clinical Research — North Miami, Florida, United States (Active_not_recruiting)
- Medical Research Group of Central Florida — Orange City, Florida, United States (Recruiting)
- APG Research, LLC — Orlando, Florida, United States (Recruiting)
- Combined Research Orlando Phase I-IV — Orlando, Florida, United States (Recruiting)
- Omega Research Consultants — Orlando, Florida, United States (Completed)
- IMIC Inc — Palmetto Bay, Florida, United States (Withdrawn)
- MedBio Trials — Pembroke Pines, Florida, United States (Completed)
- Lenus Research & Medical Group, LLC — Sweetwater, Florida, United States (Withdrawn)
- Stedman Clinical Trials — Tampa, Florida, United States (Completed)
+46 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Chief Medical Officer
- Email: clinicaltrials@biohavenpharma.com
- Phone: 203-404-0410
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.