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Completed

NCT Number: NCT04641143

Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder

The study's purpose is to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD)

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Metropolitan Neuro Behavioral Institute, Chandler, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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
  • 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

  • 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.
  • 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
  • Previous treatment in a study with troriluzole

Treatment and study plan

Troriluzole

Drug

Troriluzole - 2 100mg capsules QD for the first two weeks.

Placebo

Drug

Matching placebo - 2 140mg capsules QD from week two through week ten.

Primary outcomes

  1. The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS)

    Time frame: Change in total score from baseline, assessed at screening, baseline, week 4, 8 &10

    Improvement is measured by a lower total score

Secondary outcomes

  1. Frequency of SAEs and AEs leading to discontinuation

    Time frame: From Screening through study completion, up to 10 weeks

    Percent difference between troriluzole vs placebo treatment emergent adverse events.

  2. Improvement in functional disability as assessed by the change in Sheehan Disability Scale (SDS)

    Time frame: From baseline through study completion (up to 10 weeks)

    Change is measured as "mild" or "moderate" on the SDS

  3. Improvement in global functioning responses assessed on the CGI-I scale.

    Time frame: From baseline through study completion (up to 10 weeks)

    Change is measured as "much improved" or "very much improved" on the CGII scale

Sponsors and collaborators

Lead sponsor

Biohaven Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Nov 23, 2020
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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