Trial · NCT03299166
Troriluzole (BHV-4157) in Adult Participants With Obsessive Compulsive Disorder
NCT03299166, Phase 2, Phase 3, Completed, Biohaven Pharmaceuticals, Inc.; results first posted 2023-06-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Troriluzole (BHV-4157) in Adult Participants With Obsessive Compulsive Disorder. Trials, record NCT03299166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03299166
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Troriluzole (BHV-4157) in Adult Participants With Obsessive Compulsive Disorder
- NCT number
- NCT03299166
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 426 participants, actual
- Lead sponsor
- Biohaven Pharmaceuticals, Inc.
- Conditions
- Obsessive-Compulsive Disorder
- Interventions
- Troriluzole, Placebo
- First posted
- 2017-10-02
- Last updated
- 2026-01-22
- Results first posted
- 2023-06-02
- Limitations and caveats
- The provided results are from the DB Randomization Phase as the Open-Label Extension phase is still on-going.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score | Baseline, Week 12 | 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. |
| Secondary | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the DB Randomization Phase | Up to 12 weeks | An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may not have resulted in death, been life-threatening, or required hospitalization, or, based upon appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent other serious outcomes. |
| Secondary | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the Open-Label Extension Phase | Up to 192 weeks | An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may not have resulted in death, been life-threatening, or required hospitalization, or, based upon appropriate medical judgment may, have jeopardized the participant and may have required medical or surgical intervention to prevent other serious outcomes. |
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase | Up to 12 weeks | Clinically significant laboratory abnormalities were defined as Grade 3 or 4 laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events Version 5.0 (2017) if available; otherwise, according to Division of Acquired Immune Deficiency Syndrome Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017). Laboratory tests of clinical interest for troriluzole included absolute neutrophil count \< 500 per mm\^3, alanine aminotransferase or aspartate aminotransferase \> 3x upper limit of normal (ULN), and total bilirubin ≥ 2x ULN (Laboratory results were presented in US units). |
| Secondary | Change From Baseline in Functional Disability Assessed Using the Sheehan Disability Scale (SDS) Total Score | Baseline, Week 12 | The 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). If the participant has not worked or studied for reasons unrelated to OCD, then the total score was considered as missing. |
| Secondary | Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score | Baseline, Week 12 | Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). |
| Secondary | Change From Baseline in the Y-BOCS Obsessions Sub-Scale Score | Baseline, Week 12 | The Y-BOCS Obsessions Sub-scale consists of the last 5 items on the Y-BOCS and is measured on a scale of 0 to 20. A higher score on the Y-BOCS corresponds to greater symptom severity. |
| Other | Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score at Weeks 4 and 8 | Baseline, Week 4 and Week 8 | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score | Baseline, Week 12 | mITT: Randomized participants who received at least 1 dose of study therapy and provided a non-missing baseline assessment and at least 1 non-missing post-baseline efficacy assessment in the randomization phase. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the DB Randomization Phase | Up to 12 weeks | Treated participants in the randomization phase | participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the Open-Label Extension Phase | Up to 192 weeks | |||
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase | Up to 12 weeks | Treated participants in the randomization phase | participants | NUMBER |
| SECONDARY | Change From Baseline in Functional Disability Assessed Using the Sheehan Disability Scale (SDS) Total Score | Baseline, Week 12 | The mITT participants in the randomization phase with available data were analyzed | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score | Baseline, Week 12 | mITT participants | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Y-BOCS Obsessions Sub-Scale Score | Baseline, Week 12 | mITT participants | Scores on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score at Weeks 4 and 8 | Baseline, Week 4 and Week 8 | mITT participants | Scores on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score | Troriluzole - Randomization Phase | -5.91 | 95% Confidence Interval -7.05 to -4.77 | Scores on a scale | |
| Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score | Placebo - Randomization Phase | -4.91 | 95% Confidence Interval -6.03 to -3.79 | Scores on a scale | |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the DB Randomization Phase | Troriluzole - Randomization Phase | Participants with at least 1 AE | 61 | participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the DB Randomization Phase | Placebo - Randomization Phase | Participants with at least 1 AE | 61 | participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the DB Randomization Phase | Troriluzole - Randomization Phase | Participants with at least 1 SAE | 0 | participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the DB Randomization Phase | Placebo - Randomization Phase | Participants with at least 1 SAE | 0 | participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the DB Randomization Phase | Troriluzole - Randomization Phase | Participants with at least 1 AEs Leading to Study Drug Discontinuation | 13 | participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the DB Randomization Phase | Placebo - Randomization Phase | Participants with at least 1 AEs Leading to Study Drug Discontinuation | 5 | participants | |
| Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase | Troriluzole - Randomization Phase | Hemoglobin, serum | 0 | participants | |
| Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase | Placebo - Randomization Phase | Hemoglobin, serum | 0 | participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Troriluzole - Randomization Phase | 124 | |
| Overall Study | STARTED | Placebo - Randomization Phase | 124 | |
| Overall Study | Treated | Troriluzole - Randomization Phase | 122 | |
| Overall Study | Treated | Placebo - Randomization Phase | 122 | |
| Overall Study | Modified Intent-to- Treat (mITT) Participants | Troriluzole - Randomization Phase | 115 | |
| Overall Study | Modified Intent-to- Treat (mITT) Participants | Placebo - Randomization Phase | 117 | |
| Overall Study | COMPLETED | Troriluzole - Randomization Phase | 101 | |
| Overall Study | COMPLETED | Placebo - Randomization Phase | 109 | |
| Overall Study | NOT COMPLETED | Troriluzole - Randomization Phase | 23 | |
| Overall Study | NOT COMPLETED | Placebo - Randomization Phase | 15 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Troriluzole - Randomization Phase | 10 | 122 | |
| other | Headache | Nervous system disorders | Placebo - Randomization Phase | 8 | 122 | |
| other | Dizziness | Nervous system disorders | Troriluzole - Randomization Phase | 9 | 122 | |
| other | Dizziness | Nervous system disorders | Placebo - Randomization Phase | 2 | 122 | |
| other | Somnolence | Nervous system disorders | Troriluzole - Randomization Phase | 8 | 122 | |
| other | Somnolence | Nervous system disorders | Placebo - Randomization Phase | 2 | 122 | |
| other | Diarrhoea | Gastrointestinal disorders | Troriluzole - Randomization Phase | 1 | 122 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo - Randomization Phase | 9 | 122 | |
| other | Nausea | Gastrointestinal disorders | Troriluzole - Randomization Phase | 8 | 122 | |
| other | Nausea | Gastrointestinal disorders | Placebo - Randomization Phase | 2 | 122 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Troriluzole - Randomization Phase | 0 | 122 |
| Total, all-cause mortality | Placebo - Randomization Phase | 0 | 122 |
| Total, other adverse events | Troriluzole - Randomization Phase | 35 | 122 |
| Total, other adverse events | Placebo - Randomization Phase | 24 | 122 |
| Total, serious adverse events | Troriluzole - Randomization Phase | 0 | 122 |
| Total, serious adverse events | Placebo - Randomization Phase | 0 | 122 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Troriluzole - Randomization Phase vs Placebo - Randomization Phase: deaths from any cause | Trial comparisons |
| Troriluzole - Randomization Phase vs Placebo - Randomization Phase: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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