Obsessive-Compulsive DisorderPhase 3NCT04693351
A Study to Evaluate the Efficacy and Safety 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 89 sites in 7 countries.
Trial summary
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). 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
- 589 participants
- Where
- 89 sitesin 7 countries
- Study dates
- 29 Jan 2021to 29 Apr 2025
- Phase
- Phase 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 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
- An inadequate response to current standard of care (SOC) 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 US Package Insert [USPI] labelling); an inadequate response to current SOC based on the Yale-Brown Obsessive Compulsive Scale (YBOCS) score.
- 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 trail as designed.
Who cannot join
- Participants 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 Massachusetts General Hospital Treatment Response Questionnaire for OCD (MGH-TRQ-OCD).
- Current or prior history of bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autism 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
89 sites in 7 countries.
89 sites in 7 countries
United States49 sites
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104
Topaz Clinical Research
Apopka, Florida, 32703
Donald J. Garcia Jr., MD PA
Austin, Texas, 78737
Inquest Clinical Research
Baytown, Texas, 77521
Boston Clinical Trials
Boston, Massachusetts, 02131
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235
Center for Emotional Fitness
Cherry Hill, New Jersey, 08028
University of Chicago Department of Psychiatry & Behavioral Neuroscience
Chicago, Illinois, 60637
CTI Clinical Research Center
Cincinnati, Ohio, 45212
CNS Research of Coral Springs
Coral Springs, Florida, 33067
ProScience Research Group
Culver City, California, 90230
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231
American Clinical Research Institute (ACRI)
Dayton, Ohio, 45432
CenExel iResearch
Decatur, Georgia, 30030
Mountain View Clinical Research
Denver, Colorado, 80209
InSite Clinical Research
DeSoto, Texas, 75115
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912
University of Florida Department of Psychiatry
Gainesville, Florida, 32606
Clinical Trial Network
Houston, Texas, 77074
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
American Research Institute (ACRI)
Kettering, Ohio, 45439
Kaizen Brain Center
La Jolla, California, 92037
Om Research LLC
Lancaster, California, 93534
CalNeuro Research Group
Los Angeles, California, 90024
Suburban Research Associates
Media, Pennsylvania, 19063
Med-Care Research
Miami, Florida, 33165
Ezy Medical Research, Co.
Miami, Florida, 33175
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130
Boeson Research
Missoula, Montana, 59804
AMR-Baber Research, Inc.
Naperville, Illinois, 60563
Advanced Research for Health Improvement
Naples, Florida, 34102
Manhattan Behavioral Medicine, PLLC
New York, New York, 10036
Harmony Clinical Research
North Miami Beach, Florida, 33162
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368
Collective Medical Research
Overland Park, Kansas, 66210
dTMS Center LLC
Palm Beach, Florida, 33480
Alea Research
Phoenix, Arizona, 85012
DMI Research
Pinellas Park, Florida, 33782
AIM Trials
Plano, Texas, 75093
Richard H. Weisler, MD PA & Associates
Raleigh, North Carolina, 27609
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Lumos Clinical Research Center, LLC
San Jose, California, 95124
Velocity Clinical Research
Santa Ana, California, 92704
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403
Renew Health Clinical Research, LLC
Snellville, Georgia, 30078
Continental Clinical Solutions, LLC
Towson, Maryland, 21204
Pacific Clinical Research Medical Group
Upland, California, 91786
Woodstock Research Center
Woodstock, Vermont, 05091
China11 sites
Beijing HuiLongGuan Hospital
Beijing, Changping District, 100085
Peking University Sixth Hospital
Beijing, Haidian District, 100083
Mental Health Center, West China Hospital, Sichuan University
Chengdu, Wuhou District, 610041
The First Affiliated Hospital of Jinan University
Guangzhou, Tianhe District, 510660
Hangzhou Seventh People's Hospital
Hangzhou, Hangzhou City, 310063
Nanjing Brain Hospital
Nanjing, Jiangsu, 210029
Shanghai Mental Health Center
Shanghai, Minhang District, 201108
First Hospital of Hebei Medical University
Shijiazhuang, Yuhua District, 050001
Tianjin Anding Hospital
Tianjin, Hexi District, 300222
Wuhan Mental Health Center
Wuhan, Qiaokou District, 430022
The Second Xiangya Hospital of Central South University
Xiangya, Hunan, 410008
United Kingdom10 sites
MAC Clinical Research-Lancashire
Blackpool, FY2 0JH
MAC Clinical Research - South Staffordshire
Cannock, South Staffordshire, WS11 0BN
MAC Clinical Research
Leeds, LS10 1DU
MAC Clinical Research -- Merseyside
Liverpool, L34 1BH
Greater Manchester Mental Health NHS Foundation Trust
Manchester, M25 3BL
Bioluminux Ltd
Milton Keynes, MK15 0DU
MAC Clinical Research
Stockton-on-Tees, County Durham, TS17 6EW
Stemax Consult - Healthcare Services Ltd
Stony Stratford, Northamptonshire, MK19 6FG
Kingshill Research Centre
Swindon, SN3 6BW
MAC Clinical Research-- South Yorkshire
Tankersley, S75 3DL
Canada7 sites
University of Calgary
Calgary, Alberta, T2N 4Z6
Chatham-Kent Clinical Trials Research Centre
Chatham, Ontario, N7L 1C1
McMaster University, Hamilton Health Sciences
Hamilton, Ontario, L8S 1B7
Queen's University
Kingston, Ontario, K7L 5G2
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
START Clinic for Mood and Anxiety Disorders
Toronto, Ontario, M4W 2N4
University of Toronto / Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, M6J 1H4
Spain6 sites
Hospital Universitario de Bellvitge
Barcelona, 08907
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Clínico San Carlos
Madrid, 28040
Centro de Salud Mental La Corredoria
Oviedo, 33011
Centro de Salud San Juan
Salamanca, 37005
Hospital Álvaro Cunqueiro
Vigo, 36312
Italy4 sites
ASST FBF SACCO - Ospedale Universitario Luigi Sacco
Milan, 20157
University School of Medicine of Napoli Federico II
Naples, 80131
University of Pisa
Pisa, 56126
University of Turin - university hospital san luigi gonzaga
Turin, 10043
Netherlands2 sites
Amsterdam UMC, locatie AMC
Amsterdam, 1100
Leiden University Medical Center (LUMC)
Leiden, 2333
About this study
Official title: A Randomized, Double-Blind, Placebo- Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder
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).
- 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
Capsules for oral administration.
PlaceboDrug
Drug- matching capsules for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Troriluzole |
| Placebo | Placebo comparator | Participants received placebo-matched to troriluzole capsules orally once daily for 10 weeks of the double-blind randomization phase. 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 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.
Measured: Baseline and Week 8
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start29 Jan 2021
- Primary completion29 Apr 2025
- Study completion29 Apr 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 589 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
- NCT04693351
- Sponsor's protocol ID
- BHV4157-303
- Other IDs
- 2024-514585-39-00
- Status last verified
- Apr 2026
- First submitted
- 30 Dec 2020
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 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
- NCT04693351
- Acronym / sponsor ID
- BHV4157-303
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-Compulsive Disorder (OCD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 589 participants (actual)
- Lead sponsor
- Biohaven Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Posted 22 May 2026
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 was to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in participants 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 | Experimental | Drug: TroriluzoleParticipants 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 | Drug: PlaceboParticipants received placebo-matched to troriluzole capsules orally once daily for 10 weeks of the double-blind randomization phase. |
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 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
- An inadequate response to current standard of care (SOC) 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 US Package Insert [USPI] labelling); an inadequate response to current SOC based on the Yale-Brown Obsessive Compulsive Scale (YBOCS) score.
- 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 trail as designed.
Key exclusion criteria (3 listed)
- Participants 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 Massachusetts General Hospital Treatment Response Questionnaire for OCD (MGH-TRQ-OCD).
- Current or prior history of bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autism 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 |
|---|---|---|
| TroriluzoleCapsules for oral administration. | Drug | Troriluzole |
| PlaceboDrug- matching capsules for oral administration. | Drug | Placebo |
Primary outcome
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)
Time frame: Baseline and Week 8
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.
3 secondary outcomes
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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
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
Time frame: Baseline and Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
89 sites in 7 countries: 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 89 sites in 7 countries.
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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in United States, China, United Kingdom, Canada, Spain and 2 more countries. 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?
Yes. Results are posted in the registry (first posted 22 May 2026). 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 Y-BOCS Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8 (Negative Change Indicates Symptom Improvement) (time frame: Baseline and Week 8). 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 May 2026.