A Phase 3 interventional study of Troriluzole and Placebo in Obsessive-Compulsive Disorder, sponsored by Biohaven Pharmaceuticals, Inc.. Completed at 89 sites in 7 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Biohaven Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
The purpose of this study was to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in participants with Obsessive Compulsive Disorder (OCD).
635 studies on the registry are indexed under Obsessive-Compulsive Disorder; 166 are open to participants now.
This study's enrollment of 589 is above the median of 45 across 520 interventional studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →Biohaven Pharmaceuticals, Inc. is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 6 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Troriluzole
Participants received placebo-matched to troriluzole capsules orally once daily for 10 weeks of the double-blind randomization phase.
Drug: Placebo
Capsules for oral administration.
Drug- matching capsules for oral administration.
Change From Baseline in the Y-BOCS Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8 (Negative Change Indicates Symptom Improvement)
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.
Time frame: Baseline and Week 8
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An Adverse event (AE) was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant, that did not necessarily have a causal relationship with treatment. An AE could be any unfavourable/unintended sign including an abnormal laboratory finding, symptom/disease temporally associated with the use of the study drug, whether or not considered related to it. A TEAE was defined as any AE that developed, worsened, or became serious after first dose of test treatment
Time frame: From first dose up to approximately 12 weeks
Change From Baseline in Sheehan Disability Scale (SDS) Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8
The SDS was a participant-rated measure of functional disability. SDS was assessed in 3 domains: work/school (0-10), social life (0-10), and family life (0-10). The score from each domain was summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). Higher scores indicated a more severe impairment.
Time frame: Baseline and Week 8
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8
The CGI-S was a clinician rated assessment of the participants current illness state on a 7-point scale. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores indicated a more severe illness.
Time frame: Baseline and Week 8
Change From Baseline in the Y-BOCS Total Score in the Baseline Y-BOCS = 22 or 23 Stratification Cohort at Week 8 (Negative Change Indicates Symptom Improvement)
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.
Time frame: Baseline and Week 8
A total 589 participants were randomized, and 581 participants received at least one dose of study treatment. The study was conducted at multiple sites in the United States, United Kingdom, China and Europe.
| Milestone | Troriluzole | Placebo |
|---|---|---|
| Started | 294 | 295 |
| Treated | 292 | 289 |
| Y-bocs score >=24 cohort | 259 | 257 |
| Y-bocs score 22-23 cohort | 35 | 38 |
| Completed | 256 | 258 |
| Not completed | 38 | 37 |
| Withdrew: Adverse event | 12 | 9 |
| Withdrew: Lack of efficacy | 1 | 1 |
| Withdrew: Non-compliance | 0 | 2 |
| Withdrew: Protocol violation | 0 | 2 |
| Withdrew: Withdrawal by subject | 17 | 14 |
| Withdrew: Lost to follow-up | 6 | 7 |
| Withdrew: Miscellaneous | 2 | 2 |
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.
| score on a scale | Troriluzole | Placebo |
|---|---|---|
| Change From Baseline in the Y-BOCS Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8 (Negative Change Indicates Symptom Improvement) | -3.62 ± 0.446 | -4.59 ± 0.454 |
An Adverse event (AE) was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant, that did not necessarily have a causal relationship with treatment. An AE could be any unfavourable/unintended sign including an abnormal laboratory finding, symptom/disease temporally associated with the use of the study drug, whether or not considered related to it. A TEAE was defined as any AE that developed, worsened, or became serious after first dose of test treatment
| Participants | Troriluzole | Placebo |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 199 | 172 |
The SDS was a participant-rated measure of functional disability. SDS was assessed in 3 domains: work/school (0-10), social life (0-10), and family life (0-10). The score from each domain was summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). Higher scores indicated a more severe impairment.
| score on a scale | Troriluzole | Placebo |
|---|---|---|
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8 | -2.47 ± 0.530 | -3.57 ± 0.538 |
The CGI-S was a clinician rated assessment of the participants current illness state on a 7-point scale. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores indicated a more severe illness.
| score on a scale | Troriluzole | Placebo |
|---|---|---|
| Change From Baseline in Clinical Global Impression of Severity (CGI-S) Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8 | -0.38 ± 0.068 | -0.49 ± 0.069 |
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.
| score on a scale | Troriluzole | Placebo |
|---|---|---|
| Change From Baseline in the Y-BOCS Total Score in the Baseline Y-BOCS = 22 or 23 Stratification Cohort at Week 8 (Negative Change Indicates Symptom Improvement) | -3.81 ± 1.441 | -4.20 ± 1.339 |
Collected over For Adverse Events: From first dose up to approximately 12 weeks For All-cause Mortality: From Day 1 up to approximately 12 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Troriluzole | 0/294 (0%) | 3/292 (1%) | 116/292 (39.7%) |
| Placebo | 0/295 (0%) | 2/289 (0.7%) | 85/289 (29.4%) |
| Event | Troriluzole | Placebo |
|---|---|---|
| PneumoniaInfections and infestations | 0/292 | 1/289 |
| Lower limb fractureInjury, poisoning and procedural complications | 0/292 | 1/289 |
| Obsessive-compulsive disorderPsychiatric disorders | 1/292 | 0/289 |
| Panic attackPsychiatric disorders | 1/292 | 0/289 |
| HaemorrhoidsGastrointestinal disorders | 1/292 | 0/289 |
| Event | Troriluzole | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 42/292 | 24/289 |
| HeadacheNervous system disorders | 41/292 | 38/289 |
| FatigueGeneral disorders | 27/292 | 26/289 |
| DizzinessNervous system disorders | 25/292 | 11/289 |
| NasopharyngitisInfections and infestations | 15/292 | 10/289 |
| Upper respiratory tract infectionInfections and infestations | 15/292 | 9/289 |
Safety Population included enrolled participants who received at least one dose of blinded study therapy (troriluzole or placebo).
| Age, Continuous(years) | Troriluzole | Placebo | Total |
|---|---|---|---|
| Mean | 37.0 ± 12.69 | 36.8 ± 12.94 | 36.9 ± 12.81 |
| Sex: Female, Male(Participants) | Troriluzole | Placebo | Total |
|---|---|---|---|
| Female | 184 | 187 | 371 |
| Male | 108 | 102 | 210 |
| Ethnicity (NIH/OMB)(Participants) | Troriluzole | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 36 | 30 | 66 |
| Not Hispanic or Latino | 237 | 245 | 482 |
| Unknown or Not Reported | 19 | 14 | 33 |
| Race/Ethnicity, Customized(Participants) | Troriluzole | Placebo | Total |
|---|---|---|---|
| Asian | 58 | 51 | 109 |
| Black or African American | 12 | 14 | 26 |
| White | 215 | 211 | 426 |
| Other | 5 | 11 | 16 |
| Not Reported | 2 | 2 | 4 |
| Baseline (YBOCS) total score(units on a scale) | Troriluzole | Placebo | Total |
|---|---|---|---|
| Mean | 27.5 ± 3.62 | 27.6 ± 3.52 | 27.5 ± 3.57 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Troriluzole
Obsessive-Compulsive Disorder →
Biohaven Pharmaceuticals, Inc.