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CompletedNCT03299166Updated Jan 22, 2026Results posted

Troriluzole (BHV-4157) in Adult Participants With Obsessive Compulsive Disorder

A Phase 2/3 interventional study of Troriluzole and Placebo in Obsessive-Compulsive Disorder, sponsored by Biohaven Pharmaceuticals, Inc.. Completed at 57 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by Biohaven Pharmaceuticals, Inc. · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
426
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Obsessive-Compulsive Disorder
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Primary diagnosis of OCD as per the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5).

  2. Participants must be currently experiencing non-response or inadequate response to their current standard of care (SOC) medication defined as:

    1. Participant Yale-Brown Obsessive Compulsive Scale total score must be ≥ 19 at screening and Baseline, reflecting moderate or severe OCD symptoms.
    2. Participants must currently be on a SSRI, clomipramine, venlafaxine or desvenlafaxine.
  3. 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;
  4. Minimum of 6 years of education or equivalent and sufficiently fluent in English to complete necessary scales and understand consent forms;
  5. Participants must have adequate hearing, vision, and language skills to perform neuropsychiatric testing and interviews as specified in the protocol;
  6. 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;
  7. 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).
  8. WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing at Baseline;
  9. 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).
  10. The duration of the subject's OCD disease was to be ≥ 1 year.
  11. In addition, subjects had to be on stable doses of other psychotropic medication for at least 12 weeks prior to screening.
  12. Subjects had to have a Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 4 at screening and baseline.

Exclusion criteria

Exclusion Criteria:

  1. 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:

    1. 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;
    2. Adequate duration: At least 10 weeks of treatment with SSRI, clomipramine, venlafaxine, or desvenlafaxine
    3. Adequate dose: Defined by the the United States Prescribing Information labeling.
  2. 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
  3. Mini Mental State Examination (MMSE) score of \< 24 at Screening
  4. 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;
  5. Any eating disorder within the last 12 months;
  6. Acute suicidality or suicide attempt or self-injurious behavior in the last 6 months;
  7. History of psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT).
  8. Transcranial Magnetic Stimulation (TMS) is prohibited within 3 months prior to screening and during the study.
  9. 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.
  10. Creatinine ≥ 2 mg/dL.
  11. Course of treatment for participants with localized cancers (without metastatic spread) is 5 years prior to screening.
  12. 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.
  13. Previous treatment with riluzole
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
426 participants (actual)

Study arms

  • Experimental
    Troriluzole

    Drug: Troriluzole

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugTroriluzole

    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

  • DrugPlacebo

    Matching capsule once daily (QD)

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Week 12

Secondary outcomes

  1. 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.

    Time frame: Up to 12 weeks

  2. 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.

    Time frame: Up to 192 weeks

  3. 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).

    Time frame: Up to 12 weeks

  4. 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.

    Time frame: Baseline, Week 12

  5. 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).

    Time frame: Baseline, Week 12

  6. 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.

    Time frame: Baseline, Week 12

Other outcomes

  1. Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score at Weeks 4 and 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.

    Time frame: Baseline, Week 4 and Week 8

06

Results

Posted Jun 2, 2023
Limitations and caveats
The provided results are from the DB Randomization Phase as the Open-Label Extension phase is still on-going.

Participant flow

The study was conducted at 56 sites in the United States.

Participant flow — Overall Study
MilestoneTroriluzole - Randomization PhasePlacebo - Randomization Phase
Started124124
Treated122122
Modified intent-to- treat (mitt) participants115117
Completed101109
Not completed2315
Withdrew: Adverse event94
Withdrew: Withdrawal by subject65
Withdrew: Physician decision11
Withdrew: Sponsor decision30
Withdrew: Lost to follow-up24
Withdrew: Randomization error01
Withdrew: Subject unable to return due to covid10
Withdrew: Unable to complete week 12 visit at site10

Outcome measures

PrimaryChange 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.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · Scores on a scale
Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score
Scores on a scaleTroriluzole - Randomization PhasePlacebo - Randomization Phase
Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score-5.91 (-7.05 to -4.77)-4.91 (-6.03 to -3.79)
Statistical analysis
  • Troriluzole - Randomization Phase vs Placebo - Randomization Phase · Mixed Models Analysis · p = 0.2202 · Ls mean difference: -1.00 · 95% CI -2.59 to 0.60
SecondaryNumber 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.

Time frame:
Up to 12 weeks
Reported as:
Number · participants
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the DB Randomization Phase
participantsTroriluzole - Randomization PhasePlacebo - Randomization Phase
Participants with at least 1 AE6161
Participants with at least 1 SAE00
Participants with at least 1 AEs Leading to Study Drug Discontinuation135
SecondaryNumber 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.

Time frame:
Up to 192 weeks

Results for this outcome have not been posted.

SecondaryNumber 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).

Time frame:
Up to 12 weeks
Reported as:
Number · participants
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
participantsTroriluzole - Randomization PhasePlacebo - Randomization Phase
Hemoglobin, serum00
Lymphocytes, low00
Lymphocytes, high00
Neutrophils01
Platelets00
White blood cells00
Alanine Aminotransferase00
Albumin00
Alkaline Phosphatase00
Aspartate Aminotransferase20
Bicarbonate00
Bilirubin00
Calcium, low00
Calcium, high00
Creatine Kinase62
Creatinine00
Glucose, Serum, low01
Glucose, Serum, high00
Lactate Dehydrogenase00
Potassium, low00
Potassium, high10
Sodium, low01
Sodium, high00
Urate00
Glucose, Urine11
Protein, Urine00
SecondaryChange 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.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · Scores on a scale
Change From Baseline in Functional Disability Assessed Using the Sheehan Disability Scale (SDS) Total Score
Scores on a scaleTroriluzole - Randomization PhasePlacebo - Randomization Phase
Change From Baseline in Functional Disability Assessed Using the Sheehan Disability Scale (SDS) Total Score-4.68 (-6.01 to -3.36)-3.68 (-4.96 to -2.39)
SecondaryChange 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).

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · Scores on a scale
Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score
Scores on a scaleTroriluzole - Randomization PhasePlacebo - Randomization Phase
Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score-0.67 (-0.84 to -0.50)-0.59 (-0.76 to -0.42)
SecondaryChange 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.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · Scores on a scale
Change From Baseline in the Y-BOCS Obsessions Sub-Scale Score
Scores on a scaleTroriluzole - Randomization PhasePlacebo - Randomization Phase
Change From Baseline in the Y-BOCS Obsessions Sub-Scale Score-2.91 (-3.53 to -2.28)-2.55 (-3.16 to -1.93)
Other pre-specifiedChange From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score at Weeks 4 and 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.

Time frame:
Baseline, Week 4 and Week 8
Reported as:
Least squares mean · Scores on a scale
Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score at Weeks 4 and 8
Scores on a scaleTroriluzole - Randomization PhasePlacebo - Randomization Phase
Week 4-3.40 (-4.26 to -2.53)-2.93 (-3.78 to -2.08)
Week 8-5.10 (-6.16 to -4.04)-3.56 (-4.59 to -2.53)
Statistical analysis
  • Troriluzole - Randomization Phase vs Placebo - Randomization Phase · Mixed Models Analysis · p = 0.4508 · Ls mean difference: -0.46 · 95% CI -1.67 to 0.75
  • Troriluzole - Randomization Phase vs Placebo - Randomization Phase · Mixed Models Analysis · p = 0.0410 · Ls mean difference: -1.54 · 95% CI -3.02 to -0.06

Adverse events

Collected over Randomization Phase: Maximum duration: 12 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Troriluzole - Randomization Phase0/122 (0%)0/122 (0%)35/122 (28.7%)
Placebo - Randomization Phase0/122 (0%)0/122 (0%)24/122 (19.7%)
Most frequent other events
Most frequent other events
EventTroriluzole - Randomization PhasePlacebo - Randomization Phase
HeadacheNervous system disorders10/1228/122
DizzinessNervous system disorders9/1222/122
DiarrhoeaGastrointestinal disorders1/1229/122
FatigueGeneral disorders9/1225/122
SomnolenceNervous system disorders8/1222/122
NauseaGastrointestinal disorders8/1222/122
NasopharyngitisInfections and infestations7/1221/122

Baseline characteristics

Treated participants in the randomization phase: Enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).

Age, Continuous
Age, Continuous(Years)Troriluzole - Randomization PhasePlacebo - Randomization PhaseTotal
Mean37.9 ± 13.0935.5 ± 13.2636.7 ± 13.20
Sex: Female, Male
Sex: Female, Male(Participants)Troriluzole - Randomization PhasePlacebo - Randomization PhaseTotal
Female7574149
Male474895
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Troriluzole - Randomization PhasePlacebo - Randomization PhaseTotal
Hispanic or Latino101727
Not Hispanic or Latino112105217
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Troriluzole - Randomization PhasePlacebo - Randomization PhaseTotal
American Indian or Alaska Native123
Asian8715
Native Hawaiian or Other Pacific Islander000
Black or African American12719
White100103203
More than one race134
Unknown or Not Reported000
Total Y-BOCS score at Randomization
Total Y-BOCS score at Randomization(Units on a scale)Troriluzole - Randomization PhasePlacebo - Randomization PhaseTotal
Mean25.9 ± 3.9126.0 ± 4.3226.0 ± 4.11
07

Study locations

57 sites
  • Metropolitan Neuro Behavioral Institute
    Chandler, Arizona 85226, United States
  • Preferred Research Partners, Inc.
    Little Rock, Arkansas 72211, United States
  • Collaborative Neuroscience Network, LLC
    Garden Grove, California 92845, United States
  • University of California San Diego
    La Jolla, California 92037, United States
  • Synergy Research San Diego
    Lemon Grove, California 91945, United States
  • CalNeuro Research Group
    Los Angeles, California 90024, United States
  • Pacific Research Partners, LLC
    Oakland, California 94607, United States
  • NRC Research Institute
    Orange, California 92868, United States
  • Desert Valley Research
    Rancho Mirage, California 92270, United States
  • Artemis Institute for Clinical Research
    San Diego, California 92103, United States
  • Artemis Institute for Clinical Research
    San Marcos, California 92078, United States
  • Stanford University, Department of Psychiatry and Behavioral Sciences
    Stanford, California 94305-5717, United States
  • Pacific Clinical Research Medical Group
    Upland, California 91786, United States
  • Mountain View Clinical Research, Inc.
    Denver, Colorado 80209, United States
  • Institute of Living / Hartford Hospital
    Hartford, Connecticut 06106, United States
  • Yale University
    New Haven, Connecticut 06519, United States
  • Comprehensive Psychiatric Care
    Norwich, Connecticut 06360, United States
  • Gulfcoast Clinical Research Center
    Fort Myers, Florida 33912, United States
  • University of Florida Department of Psychiatry
    Gainesville, Florida 32606, United States
  • Galiz Research
    Hialeah, Florida 33016, United States
  • Clinical Neuroscience Solutions, Inc
    Jacksonville, Florida 32256, United States
  • SIH Research, Inc
    Kissimmee, Florida 34741, United States
  • Harmony Clinical Research
    North Miami Beach, Florida 33162, United States
  • Medical Research Group of Central Florida
    Orange City, Florida 32763, United States
  • Clinical Neuroscience Solutions, Inc
    Orlando, Florida 32801, United States
  • iResearch Atlanta, LLC
    Decatur, Georgia 30030, United States
  • iResearch Savannah
    Savannah, Georgia 31405, United States
  • Chicago Research Center
    Chicago, Illinois 60634, United States
  • University of Chicago Department of Psychiatry & Behavioral Neuroscience
    Chicago, Illinois 60637, United States
  • AMR-Baber Research, Inc
    Naperville, Illinois 60563, United States
  • Phoenix Medical Research, Inc.
    Prairie Village, Kansas 66208, United States
  • Heartland Research Associates, LLC
    Wichita, Kansas 67207, United States
  • Pharmasite Research, Inc.
    Pikesville, Maryland 21208, United States
  • McLean Hospital
    Belmont, Massachusetts 02478, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Boston Clinical Trials
    Boston, Massachusetts 02131, United States
  • Michigan Clinical Research PC
    Ann Arbor, Michigan 48105, United States
  • Precise Research Centers
    Flowood, Mississippi 39232, United States
  • ActivMed Practices and Research, Inc.
    Portsmouth, New Hampshire 03801, United States
  • Center for Emotional Fitness
    Cherry Hill, New Jersey 08028, United States
  • Integrative Clinical Trials LLC
    Brooklyn, New York 11229, United States
  • Bio Behavioral Institute
    Great Neck, New York 11021, United States
  • New York State Psychiatric Institute
    New York, New York 10032, United States
  • Finger Lakes Clinical Research
    Rochester, New York 14618, United States
  • Richmond Behavioral Associates
    Staten Island, New York 10312, United States
  • New Hope Clinical Research
    Charlotte, North Carolina 28211, United States
  • New Horizons Clinical Research
    Cincinnati, Ohio 45242, United States
  • Midwest Clinical Research Center
    Dayton, Ohio 45417, United States
  • Summit Research Network (Oregon) Inc.
    Portland, Oregon 97210, United States
  • Suburban Research Associates
    Media, Pennsylvania 19063, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Clinical Neuroscience Solutions, Inc.
    Memphis, Tennessee 38119, United States
  • FutureSearch Trials of Dallas, LP
    Dallas, Texas 75231, United States
  • InSite Clinical Research
    DeSoto, Texas 75115, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • Psychiatric Alliance of the Blue Ridge, Inc.
    Charlottesville, Virginia 22903, United States
  • Northwest Clinical Research Center
    Bellevue, Washington 98007, United States
08

References and documents

Study documents

  • Study protocol · Oct 13, 2022
  • Statistical analysis plan · Jun 11, 2020

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03299166
Lead sponsor
Biohaven Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Oct 2, 2017
Start date
Dec 19, 2017
Primary completion
Jun 2, 2020
Completion
Dec 8, 2025
Results posted
Jun 2, 2023
Last update
Jan 22, 2026

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
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