Obsessive-Compulsive DisorderPhase 2/3NCT03299166
Troriluzole (BHV-4157) in Adult Participants With Obsessive Compulsive Disorder
A Phase 2/3 study testing Troriluzole in people with Obsessive-Compulsive Disorder, run by Biohaven Pharmaceuticals, Inc. at 57 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of troriluzole as adjunctive therapy versus placebo in participants with obsessive compulsive disorder (OCD) who had an inadequate response to selective serotonin reuptake inhibitor (SSRI), clomipramine, venlafaxine, or desvenlafaxine treatment Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Troriluzole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 426 participants
- Where
- 57 sitesUnited States
- Study dates
- 19 Dec 2017to 8 Dec 2025
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of OCD as per the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5).
- Participants must be currently experiencing non-response or inadequate response to their current standard of care (SOC) medication defined as:
- Participant Yale-Brown Obsessive Compulsive Scale total score must be ≥ 19 at screening and Baseline, reflecting moderate or severe OCD symptoms.
- Participants must currently be on a SSRI, clomipramine, venlafaxine or desvenlafaxine.
- Determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Participants must be physically able and expected to complete the trial as designed;
- Minimum of 6 years of education or equivalent and sufficiently fluent in English to complete necessary scales and understand consent forms;
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- Participants must have adequate hearing, vision, and language skills to perform neuropsychiatric testing and interviews as specified in the protocol;
- Participants must be able to understand and agree to comply with the prescribed dosage regimens and procedures; report for regularly scheduled office visits; and reliably communicate with study personnel about adverse events and concomitant medications;
- It is required that all women of child-bearing potential (WOCBP) who are sexually active agree to use two methods of contraception for the duration of the study (i.e. beginning 30 days prior to baseline and extending to 30 days after the last dose of study drug).
- WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing at Baseline;
- It is required that men who are sexually active with WOCBP agree to use 2 methods of contraception for the duration of the study (beginning at first treatment and extending to 90 days after the last dose of study drug).
- The duration of the subject's OCD disease was to be ≥ 1 year.
- In addition, subjects had to be on stable doses of other psychotropic medication for at least 12 weeks prior to screening.
- Subjects had to have a Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 4 at screening and baseline.
Who cannot join
- Participants should be excluded with a history of more than 2 previous failed treatment trials of SSRIs, clomipramine, venlafaxine, or desvenlafaxine (not including the current SSRI trial) given for an adequate duration at an adequate dose as defined by the following criteria taken from the Massachusetts General Hospital Treatment Response Questionnaire for OCD (MGH-TRQ-OCD) as follows:
- Treatment failure / non-response: As per the MGH-TRQ-OCD, there has been minimal or no meaningful clinical benefit as perceived by the participant despite an adequate dose and duration of treatment;
- Adequate duration: At least 10 weeks of treatment with SSRI, clomipramine, venlafaxine, or desvenlafaxine
- Adequate dose: Defined by the the United States Prescribing Information labeling.
- Evidence at screening or baseline of any medical or psychiatric condition other than OCD that could predominantly explain or contribute significantly to the subjects' symptoms or that could confound assessment of OCD symptoms
- Mini Mental State Examination (MMSE) score of < 24 at Screening
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- Current or prior history, per DSM-5 criteria, of bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, antisocial personality disorder, body dysmorphic disorder, hoarding disorder (symptoms of hoarding disorder as part of the OCD diagnosis are allowed, but a primary diagnosis of hoarding disorder is excluded); a current diagnosis of Tourette's disorder is also excluded;
- Any eating disorder within the last 12 months;
- Acute suicidality or suicide attempt or self-injurious behavior in the last 6 months;
- History of psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT).
- Transcranial Magnetic Stimulation (TMS) is prohibited within 3 months prior to screening and during the study.
- Participants who may have received a non-biological investigational agent in any clinical trial within 30 days, or a biological agent within 90 days prior to screening are excluded.
- Creatinine ≥ 2 mg/dL.
- Course of treatment for participants with localized cancers (without metastatic spread) is 5 years prior to screening.
- QTcF (Fridericia) interval ≥ 470 msec during the screening or baseline period or uncontrolled arrhythmia or frequent premature ventricular contraction (PVCs) (> 5/minute) or Mobitz Type II second or third degree atrioventricular (AV) block or left bundle branch block, or right bundle branch block with a QRS duration ≥ 150 msec or intraventricular conduction defect with a QRS duration ≥150 msec or evidence of acute or sub-acute myocardial infarction or ischemia and added or other electrocardiogram findings that, in the investigator's opinion, would preclude participation in the study.
- Previous treatment with riluzole
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
United States57 sites
Michigan Clinical Research PC
Ann Arbor, Michigan, 48105
Northwest Clinical Research Center
Bellevue, Washington, 98007
McLean Hospital
Belmont, Massachusetts, 02478
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Clinical Trials
Boston, Massachusetts, 02131
Integrative Clinical Trials LLC
Brooklyn, New York, 11229
Metropolitan Neuro Behavioral Institute
Chandler, Arizona, 85226
New Hope Clinical Research
Charlotte, North Carolina, 28211
Psychiatric Alliance of the Blue Ridge, Inc.
Charlottesville, Virginia, 22903
Center for Emotional Fitness
Cherry Hill, New Jersey, 08028
Chicago Research Center
Chicago, Illinois, 60634
University of Chicago Department of Psychiatry & Behavioral Neuroscience
Chicago, Illinois, 60637
New Horizons Clinical Research
Cincinnati, Ohio, 45242
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231
Midwest Clinical Research Center
Dayton, Ohio, 45417
iResearch Atlanta, LLC
Decatur, Georgia, 30030
Mountain View Clinical Research, Inc.
Denver, Colorado, 80209
InSite Clinical Research
DeSoto, Texas, 75115
Precise Research Centers
Flowood, Mississippi, 39232
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912
University of Florida Department of Psychiatry
Gainesville, Florida, 32606
Collaborative Neuroscience Network, LLC
Garden Grove, California, 92845
Bio Behavioral Institute
Great Neck, New York, 11021
Institute of Living / Hartford Hospital
Hartford, Connecticut, 06106
Galiz Research
Hialeah, Florida, 33016
Baylor College of Medicine
Houston, Texas, 77030
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256
SIH Research, Inc
Kissimmee, Florida, 34741
University of California San Diego
La Jolla, California, 92037
Synergy Research San Diego
Lemon Grove, California, 91945
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211
CalNeuro Research Group
Los Angeles, California, 90024
Suburban Research Associates
Media, Pennsylvania, 19063
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
AMR-Baber Research, Inc
Naperville, Illinois, 60563
Yale University
New Haven, Connecticut, 06519
New York State Psychiatric Institute
New York, New York, 10032
Harmony Clinical Research
North Miami Beach, Florida, 33162
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360
Pacific Research Partners, LLC
Oakland, California, 94607
NRC Research Institute
Orange, California, 92868
Medical Research Group of Central Florida
Orange City, Florida, 32763
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pharmasite Research, Inc.
Pikesville, Maryland, 21208
Summit Research Network (Oregon) Inc.
Portland, Oregon, 97210
ActivMed Practices and Research, Inc.
Portsmouth, New Hampshire, 03801
Phoenix Medical Research, Inc.
Prairie Village, Kansas, 66208
Desert Valley Research
Rancho Mirage, California, 92270
Finger Lakes Clinical Research
Rochester, New York, 14618
Artemis Institute for Clinical Research
San Diego, California, 92103
Artemis Institute for Clinical Research
San Marcos, California, 92078
iResearch Savannah
Savannah, Georgia, 31405
Stanford University, Department of Psychiatry and Behavioral Sciences
Stanford, California, 94305-5717
Richmond Behavioral Associates
Staten Island, New York, 10312
Pacific Clinical Research Medical Group
Upland, California, 91786
Heartland Research Associates, LLC
Wichita, Kansas, 67207
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder
The purpose of this study is to evaluate the efficacy of troriluzole as adjunctive therapy versus placebo in participants with obsessive compulsive disorder (OCD) who had an inadequate response to selective serotonin reuptake inhibitor (SSRI), clomipramine, venlafaxine, or desvenlafaxine treatment
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Troriluzole, Placebo
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TroriluzoleDrug
Troriluzole, 140 mg capsules once daily (QD) orally for the first 4 weeks and 200 mg (140 mg+ 60 mg capsules QD) for an additional 8 weeks
PlaceboDrug
Matching capsule once daily (QD)
| Study group | Role | What they receive |
|---|---|---|
| Troriluzole | Experimental | Not described Receives: Drug: Troriluzole |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) 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.
Measured: Baseline, Week 12
Secondary outcomes (6)
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the DB Randomization Phase
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.
Measured: Up to 12 weeks
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the Open-Label Extension Phase
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.
Measured: Up to 192 weeks
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
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).
Measured: Up to 12 weeks
Change From Baseline in Functional Disability Assessed Using the Sheehan Disability Scale (SDS) Total Score
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.
Measured: Baseline, Week 12
Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score
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).
Measured: Baseline, Week 12
Change From Baseline in the Y-BOCS Obsessions Sub-Scale Score
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.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start19 Dec 2017
- Primary completion2 Jun 2020
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biohaven Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299166
- Sponsor's protocol ID
- BHV4157-202
- Status last verified
- Jan 2026
- First submitted
- 28 Sep 2017
- Last updated
- 22 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT03299166
- Acronym / sponsor ID
- BHV4157-202
- Conditions
- Obsessive-Compulsive Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Biohaven Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 2 Oct 2017 (actual)
- Results
- Posted 2 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of troriluzole as adjunctive therapy versus placebo in participants with obsessive compulsive disorder (OCD) who had an inadequate response to selective serotonin reuptake inhibitor (SSRI), clomipramine, venlafaxine, or desvenlafaxine treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Troriluzole | Experimental | Drug: Troriluzole |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Primary diagnosis of OCD as per the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5).
- Participants must be currently experiencing non-response or inadequate response to their current standard of care (SOC) medication defined as:
- Determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Participants must be physically able and expected to complete the trial as designed;
- Minimum of 6 years of education or equivalent and sufficiently fluent in English to complete necessary scales and understand consent forms;
- Participants must have adequate hearing, vision, and language skills to perform neuropsychiatric testing and interviews as specified in the protocol;
Key exclusion criteria (16 listed)
- Participants should be excluded with a history of more than 2 previous failed treatment trials of SSRIs, clomipramine, venlafaxine, or desvenlafaxine (not including the current SSRI trial) given for an adequate duration at an adequate dose as defined by the following criteria taken from the Massachusetts General Hospital Treatment Response Questionnaire for OCD (MGH-TRQ-OCD) as follows:
- Evidence at screening or baseline of any medical or psychiatric condition other than OCD that could predominantly explain or contribute significantly to the subjects' symptoms or that could confound assessment of OCD symptoms
- Mini Mental State Examination (MMSE) score of < 24 at Screening
- Current or prior history, per DSM-5 criteria, of bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, antisocial personality disorder, body dysmorphic disorder, hoarding disorder (symptoms of hoarding disorder as part of the OCD diagnosis are allowed, but a primary diagnosis of hoarding disorder is excluded); a current diagnosis of Tourette's disorder is also excluded;
- Any eating disorder within the last 12 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TroriluzoleTroriluzole, 140 mg capsules once daily (QD) orally for the first 4 weeks and 200 mg (140 mg+ 60 mg capsules QD) for an additional 8 weeks | Drug | Troriluzole |
| PlaceboMatching capsule once daily (QD) | Drug | Placebo |
Primary outcome
Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score
Time frame: 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.
6 secondary outcomes
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the DB Randomization Phase
Time frame: Up to 12 weeks
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the Open-Label Extension Phase
Time frame: Up to 192 weeks
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Time frame: Up to 12 weeks
Change From Baseline in Functional Disability Assessed Using the Sheehan Disability Scale (SDS) Total Score
Time frame: Baseline, Week 12
Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score
Time frame: Baseline, Week 12
Change From Baseline in the Y-BOCS Obsessions Sub-Scale Score
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
57 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Troriluzole in people with Obsessive-Compulsive Disorder, run by Biohaven Pharmaceuticals, Inc. at 57 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.