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

Biohaven Pharmaceuticals, Inc.88 sites in 2 countries589 target enrollmentJanuary 29, 2021

ConditionsObsessive-Compulsive Disorder

InterventionsTroriluzole Placebo

DrugsTroriluzole Placebo

Overview

Phase: Phase 3
Intervention: Troriluzole
Conditions: Obsessive-Compulsive Disorder
Sponsor: Biohaven Pharmaceuticals, Inc.
Enrollment: 589
Locations: 88
Primary Endpoint: The total score on the Yale-Brown Obsessive Compulsive Disorder (YBOCS)
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 29, 2021

End Date

April 29, 2025

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biohaven Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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 subjects illness must be ≥ 1year
•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 too current standard of car base on the 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. Subjects must be physically able and expected to complete the trail 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 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

Arms & Interventions

Troriluzole

Troriluzole- 2 100mg capsules once daily for the first two weeks. Troriluzole- 2 140mg capsules once daily from week two through week ten.

Intervention: Troriluzole

Placebo

Placebo- 2 100mg capsules once daily for the first two weeks. Placebo- 2 140mg capsules once daily from week two through week ten.

Intervention: Placebo

Outcomes

Primary Outcomes

The total score on the Yale-Brown Obsessive Compulsive Disorder (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

Improvement in global functioning responses as assessed on the CGI-I scale.(From baseline through study completion (up to 10 weeks))
Frequency of SAEs and AEs leading discontinuation(From Screening through Study completion, up to 10 weeks)
Improvement in function disability as assessed by the change in the Sheehan Disability Scale (SDS)(From baseline through study completion (up to 10 weeks))