NCT04641143CompletedPhase 3
A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder
Biohaven Pharmaceuticals, Inc.140 sites in 1 country456 target enrollmentStarted: December 22, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 456
- Locations
- 140
- Primary Endpoint
- The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Study Overview
Brief Summary
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Troriluzole
Active Comparator
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 (Drug)
Placebo
Placebo Comparator
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 (Drug)
Outcomes
Primary Outcomes
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
- Frequency of SAEs and AEs leading to discontinuation(From Screening through study completion, up to 10 weeks)
- Improvement in functional disability as assessed by the change in Sheehan Disability Scale (SDS)(From baseline through study completion (up to 10 weeks))
- Improvement in global functioning responses assessed on the CGI-I scale.(From baseline through study completion (up to 10 weeks))
Investigators
Study Sites (140)
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