Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder
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|ClinicalTrials.gov Identifier: NCT04641143|
Recruitment Status : Recruiting
First Posted : November 23, 2020
Last Update Posted : January 13, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Obsessive-Compulsive Disorder||Drug: Troriluzole Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||700 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder|
|Actual Study Start Date :||December 22, 2020|
|Estimated Primary Completion Date :||December 15, 2023|
|Estimated Study Completion Date :||December 15, 2023|
Active Comparator: Troriluzole
Troriluzole - 2 100mg capsules once daily for the first two weeks. Troriluzole - 2 140mg capsules once daily from week two through week ten.
Troriluzole - 2 100mg capsules QD for the first two weeks.
Placebo Comparator: Placebo
Placebo - 2 100mg capsules once daily for the first two weeks. Placebo - 2 140mg capsules once daily from week two through week ten.
Matching placebo - 2 140mg capsules QD from week two through week ten.
- 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
- 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.
- 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
- 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
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04641143
|Contact: Chief Medical Officerfirstname.lastname@example.org|
|Responsible Party:||Biohaven Pharmaceuticals, Inc.|
|Other Study ID Numbers:||
|First Posted:||November 23, 2020 Key Record Dates|
|Last Update Posted:||January 13, 2023|
|Last Verified:||January 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Compulsive Personality Disorder