Obsessive-Compulsive DisorderPhase 3NCT04641143
Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder
A Phase 3 study testing Troriluzole in people with Obsessive-Compulsive Disorder, run by Biohaven Pharmaceuticals, Inc. at 73 sites in United States.
Trial 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) 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
- 456 participants
- Where
- 73 sitesUnited States
- Study dates
- 22 Dec 2020to 27 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 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
- 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
- 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
Who cannot join
- 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.
- 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
- Previous treatment in a study with troriluzole
Trial locations and contacts
73 sites in 1 country.
73 sites in 1 country
United States73 sites
Michigan Clinical Research Institute PC
Ann Arbor, Michigan, 48105
BioBehavioral Research of Austin
Austin, Texas, 78759
Clinical Inquest Center, Ltd
Beavercreek, Ohio, 45431
Northwest Clinical Research Center
Bellevue, Washington, 98007
CITrials (Clinical Innovations)
Bellflower, California, 90706
Hassman Research Institute
Berlin, New Jersey, 08009
Boca Raton Medical Institute
Boca Raton, Florida, 33431
Northwest Clinical Trials
Boise, Idaho, 83704
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Clinical Trials
Boston, Massachusetts, 02131
Integrative Clinical Trials, LLC
Brooklyn, New York, 11229
Neurobehavioral Research, Inc
Cedarhurst, New York, 11516
Metropolitan Neuro Behavioral Institute
Chandler, Arizona, 85284
Uptown Research Institute
Chicago, Illinois, 60640
Axiom Research, LLC
Colton, California, 92324
Advanced Clinical Research Network
Coral Gables, Florida, 33134
Relaro Medical Trials
Dallas, Texas, 75243
iResearch Atlanta, LLC
Decatur, Georgia, 30030
Revive Research Institute
Elgin, Illinois, 60123
WR-PRI, LLC (Encino)
Encino, California, 91316
Precise Research Centers
Flowood, Mississippi, 39232
North Texas Clinical Trials
Fort Worth, Texas, 76104
CBH Health
Gaithersburg, Maryland, 20877
Behavioral Research Specialists, LLC
Glendale, California, 91206
Bio Behavioral Institute
Great Neck, New York, 11021
Research in Miami Inc
Hialeah, Florida, 33013
Baylor College of Medicine
Houston, Texas, 77030
Texas Center for Drug Development, Inc.
Houston, Texas, 77081
Accel Research Sites
Lakeland, Florida, 33803
Altea Research
Las Vegas, Nevada, 89102
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319
Pharmacology Research Institute
Los Alamitos, California, 90720
Clarity Clinical Research
Los Angeles, California, 90064
Suburban Research Associates
Media, Pennsylvania, 19063
ActivMed Practices and Research
Methuen, Massachusetts, 01844
Health Care Family Rehab & Research
Miami, Florida, 33015
Central Miami Medical Institute
Miami, Florida, 33125
FIRC
Miami, Florida, 33173
Florida Research Center, Inc.
Miami, Florida, 33174
South Florida Research Phase I-IV , Inc.
Miami Springs, Florida, 33166
Mt.Olympus Medical Research LLC
Missouri City, Texas, 77459
Bioscience Research, LLC
Mount Kisco, New York, 10549
AMR-Baber Research, Inc
Naperville, Illinois, 60563
Yale University / Connecticut Mental Health Center
New Haven, Connecticut, 06519
Manhattan Behavioral Medicine, PLLC
New York, New York, 10036
Behavioral Clinical Research
North Miami, Florida, 33161
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368
Excell Research, Inc
Oceanside, California, 92056
NRC Research Institute
Orange, California, 92688
Medical Research Group of Central Florida
Orange City, Florida, 32763
APG Research, LLC
Orlando, Florida, 32803
Combined Research Orlando Phase I-IV
Orlando, Florida, 32807
Omega Research Consultants
Orlando, Florida, 32808
Collective Medical Research
Overland Park, Kansas, 66210
MedBio Trials
Pembroke Pines, Florida, 33026
IMA Clinical Research
Phoenix, Arizona, 85012
NoeisisPharma, LLC
Phoenix, Arizona, 85016
Pharmasite Research, Inc.
Pikesville, Maryland, 21208
Comprehensive Psychiatric Care Providers
Providence, Rhode Island, 02906
Anderson Clinical Research
Redlands, California, 92374
Lumos Clinical Research Center, LLC
San Jose, California, 95124
iResearch Savannah
Savannah, Georgia, 31405
California Neuroscience Research Medical Group, Inc
Sherman Oaks, California, 91403
Sisu at RMG
Springfield, Massachusetts, 01103
Stanford University
Stanford, California, 94305
Richmond Behavioral Associates
Staten Island, New York, 10312
Stedman Clinical Trials
Tampa, Florida, 33613
Bio Behavioral Health
Toms River, New Jersey, 08755
Collaborative Neuroscience Research
Torrance, California, 90502
Central States Research, LLC
Tulsa, Oklahoma, 74136
Neurobehaviorial Institute
Weston, Florida, 33326
Conquest Research LLC
Winter Park, Florida, 32789
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder
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)
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Troriluzole, Placebo
- Keywords
- Obsessive-Compulsive Disorder, OCD
- 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 - 2 100mg capsules QD for the first two weeks.
PlaceboDrug
Matching placebo - 2 140mg capsules QD from week two through week ten.
| Study group | Role | What they receive |
|---|---|---|
| Troriluzole | Active comparator | Troriluzole - 2 100mg capsules once daily for the first two weeks. Troriluzole - 2 140mg capsules once daily from week two through week ten. Receives: Drug: Troriluzole |
| Placebo | Placebo comparator | Placebo - 2 100mg capsules once daily for the first two weeks. Placebo - 2 140mg capsules once daily from week two through week ten. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Improvement is measured by a lower total score
Measured: Change in total score from baseline, assessed at screening, baseline, week 4, 8 &10
Secondary outcomes (3)
Frequency of SAEs and AEs leading to discontinuation
Percent difference between troriluzole vs placebo treatment emergent adverse events.
Measured: From Screening through study completion, up to 10 weeks
Improvement in functional disability as assessed by the change in Sheehan Disability Scale (SDS)
Change is measured as "mild" or "moderate" on the SDS
Measured: From baseline through study completion (up to 10 weeks)
Improvement in global functioning responses assessed on the CGI-I scale.
Change is measured as "much improved" or "very much improved" on the CGII scale
Measured: From baseline through study completion (up to 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start22 Dec 2020
- Primary completion27 Oct 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 456 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
- NCT04641143
- Sponsor's protocol ID
- BHV4157-302
- Status last verified
- Jan 2026
- First submitted
- 12 Nov 2020
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 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
- NCT04641143
- Acronym / sponsor ID
- BHV4157-302
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-Compulsive Disorder, OCD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Biohaven Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 | Active comparator | Drug: TroriluzoleTroriluzole - 2 100mg capsules once daily for the first two weeks. Troriluzole - 2 140mg capsules once daily from week two through week ten. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo - 2 100mg capsules once daily for the first two weeks. Placebo - 2 140mg capsules once daily from week two through week ten. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- 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
- 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
Key exclusion criteria (3 listed)
- 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.
- 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
- Previous treatment in a study with troriluzole
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 - 2 100mg capsules QD for the first two weeks. | Drug | Troriluzole |
| PlaceboMatching placebo - 2 140mg capsules QD from week two through week ten. | Drug | Placebo |
Primary outcome
The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Time frame: Change in total score from baseline, assessed at screening, baseline, week 4, 8 &10
Improvement is measured by a lower total score
3 secondary outcomes
Frequency of SAEs and AEs leading to discontinuation
Time frame: From Screening through study completion, up to 10 weeks
Improvement in functional disability as assessed by the change in Sheehan Disability Scale (SDS)
Time frame: From baseline through study completion (up to 10 weeks)
Improvement in global functioning responses assessed on the CGI-I scale.
Time frame: From baseline through study completion (up to 10 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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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.
73 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Troriluzole in people with Obsessive-Compulsive Disorder, run by Biohaven Pharmaceuticals, Inc. at 73 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 3 inclusion and 3 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 7 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 73 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS) (time frame: Change in total score from baseline, assessed at screening, baseline, week 4, 8 &10). 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 7 Jan 2026.