| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04693351 | A Study to Evaluate the Efficacy and Safety of Adjunctive Troriluzole in Obsessive-Compulsive Disorder | PHASE3 | COMPLETED | 589 | — | — | Jan 29, 2021 | Apr 29, 2025 | May 22, 2026 | 89 | United States, Canada +5 |
| NCT04641143 | Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder | PHASE3 | COMPLETED | 456 | — | — | Dec 22, 2020 | Oct 27, 2025 | Jan 7, 2026 | 73 | United States |
| NCT03299166 | Troriluzole (BHV-4157) in Adult Participants With Obsessive Compulsive Disorder | PHASE2 | COMPLETED | 426 | — | — | Dec 19, 2017 | Dec 8, 2025 | Jan 22, 2026 | 57 | United States |
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.
Improvement is measured by a lower total score
The Y-BOCS is a clinician-administered scale used extensively in research and clinical practice to both rate severity of obsessive compulsive disorder (OCD) and to monitor improvement during treatment. It is designed to rate the severity of obsessions and compulsions as well as the type of symptoms in patients with OCD. The scale consists of 10 items; the first 5 items assess obsessions, and the last 5 items assess compulsions. Subscale scores can be calculated for obsessions and compulsions, each on a scale of 0 to 20. A total score ranging from 0 to 40 can then be correlated to overall severity. The higher the number on the Y-BOCS, the more severe the symptoms.
| Arm | Type | Description |
|---|---|---|
| Troriluzole | EXPERIMENTAL | Participants received troriluzole 200 milligrams (mg) (100 mg\*2) capsules orally once daily for the first two weeks and up-titrated to 280 mg (140 mg\*2) capsules orally once daily for the next eight weeks, in the double-blind randomization phase. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo-matched to troriluzole capsules orally once daily for 10 weeks of the double-blind randomization phase. |
| Name | Type | Description |
|---|---|---|
| Troriluzole | DRUG | Capsules for oral administration. |
| Placebo | DRUG | Drug- matching capsules for oral administration. |
Key Inclusion Criteria: 1. 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 2. An inadequate response t...