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CompletedPhase 3

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

Key facts

Who runs it
Biohaven Pharmaceuticals, Inc.
Where
Allentown, Apopka, Austin, Baytown, Boston, Brooklyn, Cherry Hill, Chicago, Cincinnati, Coral Springs, Culver City, Dallas, Dayton, Decatur, Denver, DeSoto, Fort Myers, Gainesville, Houston, Jacksonville, Kettering, La Jolla, Lancaster, Los Angeles, Media, Miami, Middleburg Heights, Missoula, Naperville, Naples, New York, North Miami Beach, Norwich, O'Fallon, Overland Park, Palm Beach, Phoenix, Pinellas Park, Plano, Raleigh, San Antonio, San Jose, Santa Ana, Sherman Oaks, Snellville, Towson, Upland, and Woodstock, United StatesSee the 49 sitesAlso in 6 other countries, 39 sites
Status
Completed
Phase
Phase 3
People taking part
589 people enrolled
Started
29 Jan 2021
Ended
29 Apr 2025
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Troriluzole
  • Placebo
Record updated
22 May 2026

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • Primary diagnosis of OCD as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the Mini International Neuropsychiatric Interview (MINI) at screening; the duration of the participants illness must be ≥ 1year
  • An inadequate response to current standard of care (SOC) 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 US Package Insert [USPI] labelling); an inadequate response to current SOC based on the Yale-Brown Obsessive Compulsive Scale (YBOCS) score
  • Determined by the investigator to be medically stable at baseline/ randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Participants must be physically able and expected to complete the trail as designed

Who cannot take part

  • Participants 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 Massachusetts General Hospital Treatment Response Questionnaire for OCD (MGH-TRQ-OCD)
  • Current or prior history of bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autism 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
  • Previous treatment in a study with troriluzole

Where in United States

Also in 6 other countries, 39 sites

  • Lehigh Center for Clinical ResearchAllentown, United States
  • Topaz Clinical ResearchApopka, United States
  • Donald J Garcia Jr, MD, PAAustin, United States
  • Inquest Clinical ResearchBaytown, United States
  • Boston Clinical TrialsBoston, United States
  • SPRI Clinical Trials, LLCBrooklyn, United States
  • Center For Emotional FitnessCherry Hill, United States
  • University of Chicago Department of Psychiatry & Behavioral NeuroscienceChicago, United States
  • CTI Clinical Research CenterCincinnati, United States
  • CNS Research of Coral SpringsCoral Springs, United States
  • ProScience Research GroupCulver City, United States
  • FutureSearch Trials of Dallas, LPDallas, United States
  • American Clinical Research Institute (ACRI)Dayton, United States
  • CenExel iResearchDecatur, United States
  • Mountain View Clinical ResearchDenver, United States
  • InSite Clinical ResearchDeSoto, United States
  • Gulfcoast Clinical Research CenterFort Myers, United States
  • University of Florida Department of PsychiatryGainesville, United States
  • Clinical Trial NetworkHouston, United States
  • Clinical NeuroScience Solutions IncJacksonville, United States
  • American Research Institute (ACRI)Kettering, United States
  • Kaizen Brain CenterLa Jolla, United States
  • Om Research LLCLancaster, United States
  • CalNeuro Research GroupLos Angeles, United States
  • Suburban Research AssociatesMedia, United States
  • Ezy Medical Research Co.Miami, United States
  • Med-Care ResearchMiami, United States
  • North Star Medical Research, LLCMiddleburg Heights, United States
  • Boeson ResearchMissoula, United States
  • AMR-Baber Research IncNaperville, United States
  • Advanced Research for Health ImprovementNaples, United States
  • Manhattan Behavioral Medicine PLLCNew York, United States
  • Harmony Clinical ResearchNorth Miami Beach, United States
  • Comprehensive Psychiatric CareNorwich, United States
  • Psychiatric Care and Research CenterO'Fallon, United States
  • Collective Medical ResearchOverland Park, United States
  • DTMS Center LLCPalm Beach, United States
  • Alea ResearchPhoenix, United States
  • DMI ResearchPinellas Park, United States
  • AIM TrialsPlano, United States
  • Richard H. Weisler, MD PA & AssociatesRaleigh, United States
  • Clinical Trials of Texas IncSan Antonio, United States
  • Lumos Clinical Research Center LLCSan Jose, United States
  • Velocity Clinical ResearchSanta Ana, United States
  • California Neuroscience Research Medical Group, Inc.Sherman Oaks, United States
  • Renew Health Clinical Research LLCSnellville, United States
  • Continental Clinical Solutions, LLCTowson, United States
  • Pacific Clinical Research Medical GroupUpland, United States
  • Woodstock Research CenterWoodstock, United States

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • TroriluzoleTreatment being tested

    Participants received troriluzole 200 milligrams (mg) (100 mg\*2) capsules orally once daily for the first two weeks and up-titrated to 280 mg (140 mg\*2) capsules orally once daily for the next eight weeks, in the double-blind randomization phase.

  • PlaceboPlacebo, for comparison

    Participants received placebo-matched to troriluzole capsules orally once daily for 10 weeks of the double-blind randomization phase.

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Randomized, Double-Blind, Placebo- Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder
Record updated
22 May 2026