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Completed

NCT Number: NCT04693351

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

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).

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Calgary, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

Treatment and study plan

Troriluzole

Drug

Capsules for oral administration.

Placebo

Drug

Drug- matching capsules for oral administration.

Primary outcomes

  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

    Y-BOCS was a clinician-administered instrument used to assess the severity of obsessive compulsive disorder (OCD) symptoms and to monitor treatment response. The scale included 10 items: 5 items assessed obsessions and 5 items assessed compulsions. Each item was rated from 0 to 4, generating an obsessions subscale score (0-20), a compulsions subscale score (0-20), and a total score ranging from 0 to 40. Higher scores indicated greater OCD symptom severity. Negative change (or reduction in score) indicates improvement.

Secondary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: From first dose up to approximately 12 weeks

    An Adverse event (AE) was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant, that did not necessarily have a causal relationship with treatment. An AE could be any unfavourable/unintended sign including an abnormal laboratory finding, symptom/disease temporally associated with the use of the study drug, whether or not considered related to it. A TEAE was defined as any AE that developed, worsened, or became serious after first dose of test treatment

  2. Change From Baseline in Sheehan Disability Scale (SDS) Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8

    Time frame: Baseline and Week 8

    The SDS was a participant-rated measure of functional disability. SDS was assessed in 3 domains: work/school (0-10), social life (0-10), and family life (0-10). The score from each domain was summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). Higher scores indicated a more severe impairment.

  3. Change From Baseline in Clinical Global Impression of Severity (CGI-S) Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8

    Time frame: Baseline and Week 8

    The CGI-S was a clinician rated assessment of the participants current illness state on a 7-point scale. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores indicated a more severe illness.

Other outcomes

  1. Change From Baseline in the Y-BOCS Total Score in the Baseline Y-BOCS = 22 or 23 Stratification Cohort at Week 8 (Negative Change Indicates Symptom Improvement)

    Time frame: Baseline and Week 8

    Y-BOCS was a clinician-administered instrument used to assess the severity of obsessive compulsive disorder (OCD) symptoms and to monitor treatment response. The scale included 10 items: 5 items assessed obsessions and 5 items assessed compulsions. Each item was rated from 0 to 4, generating an obsessions subscale score (0-20), a compulsions subscale score (0-20), and a total score ranging from 0 to 40. Higher scores indicated greater OCD symptom severity. Negative change (or reduction in score) indicates improvement.

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
2021
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2021
Registry last updated
May 22, 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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