Obsessive-Compulsive Disorder
Conditions
Keywords
Obsessive-Compulsive Disorder, OCD
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)
Interventions
DRUGTroriluzole
Troriluzole - 2 100mg capsules QD for the first two weeks.
DRUGPlacebo
Matching placebo - 2 140mg capsules QD from week two through week ten.
Sponsors
Biohaven Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. 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 3. 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
1. 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. 2. 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 3. Previous treatment in a study with troriluzole
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS) | Change in total score from baseline, assessed at screening, baseline, week 4, 8 &10 | Improvement is measured by a lower total score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of SAEs and AEs leading to discontinuation | 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) | 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. | From baseline through study completion (up to 10 weeks) | Change is measured as much improved or very much improved on the CGII scale |
Countries
United States
Outcome results
None listed