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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Troriluzole | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Troriluzole | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
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;
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.
Exclusion Criteria:
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;
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metropolitan Neuro Behavioral Institute | Chandler | Arizona | 85226 | United States | ||
| Preferred Research Partners, Inc. |
A total of 426 participants were enrolled, of which 248 participants were randomized in a 1:1: ratio to receive troriluzole (BHV-4157) or placebo. A total of 178 participants were not randomized due to withdrawal of consent, lost to follow-up, failed inclusion/exclusion criteria, or other reasons.
The study was conducted at 56 sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Troriluzole - Randomization Phase | Randomization phase (Weeks 1 through 12): Participants received 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 in the double-blind (DB) randomization phase. |
| FG001 |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 13, 2022 | Apr 19, 2023 |
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| Placebo | Drug | Matching capsule once daily (QD) |
|
| 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. | 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). | 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. | 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). | 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. | Baseline, Week 12 |
| Baseline, Week 4 and Week 8 |
| 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 |
| Placebo - Randomization Phase |
Randomization phase (Weeks 1 through 12): Participants received troriluzole matching placebo capsules QD orally for up to 12 weeks in the DB randomization phase. |
|
| Treated |
|
| Modified Intent-to- Treat (mITT) Participants | Modified intent-to-treat (mITT) participants in the randomization phase included randomized participants who received at least 1 dose of blinded study drug and provided a non-missing baseline assessment and at least 1 non-missing post-baseline efficacy assessment. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated participants in the randomization phase: Enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
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| ID | Title | Description |
|---|---|---|
| BG000 | Troriluzole - Randomization Phase | Randomization phase (Weeks 1 through 12): Participants received 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 in the double-blind (DB) randomization phase. |
| BG001 | Placebo - Randomization Phase | Randomization phase (Weeks 1 through 12): Participants received troriluzole matching placebo capsules QD orally for up to 12 weeks in the DB randomization phase. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Total Y-BOCS score at Randomization | The Yale-Brown Obsessive Compulsive Scale (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. 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. | Mean | Standard Deviation | Units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | mITT: Randomized participants who received at least 1 dose of study therapy and provided a non-missing baseline assessment and at least 1 non-missing post-baseline efficacy assessment in the randomization phase. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline, Week 12 |
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| Secondary | 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. | Treated participants in the randomization phase | Posted | Number | participants | Up to 12 weeks |
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| Secondary | 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. | Not Posted | Dec 2026 | Up to 192 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Treated participants in the randomization phase | Posted | Number | participants | Up to 12 weeks |
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| Secondary | 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. | The mITT participants in the randomization phase with available data were analyzed | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline, Week 12 |
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| Secondary | 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). | mITT participants | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline, Week 12 |
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| Secondary | 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. | mITT participants | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline, Week 12 |
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| Other Pre-specified | 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. | mITT participants | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline, Week 4 and Week 8 |
|
Randomization Phase: Maximum duration: 12 weeks
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Troriluzole - Randomization Phase | Randomization phase (Weeks 1 through 12): Participants received 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 in the double-blind (DB) randomization phase. | 0 | 122 | 0 | 122 | 35 | 122 |
| EG001 | Placebo - Randomization Phase | Randomization phase (Weeks 1 through 12): Participants received troriluzole matching placebo capsules QD orally for up to 12 weeks in the DB randomization phase. | 0 | 122 | 0 | 122 | 24 | 122 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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The provided results are from the DB Randomization Phase as the Open-Label Extension phase is still on-going.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Biohaven Pharmaceuticals, Inc. | 203-404-0410 | clinicaltrials@biohavenpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 11, 2020 | Apr 19, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Randomization phase (Weeks 1 through 12): Participants received troriluzole matching placebo capsules QD orally for up to 12 weeks in the DB randomization phase.
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| Participants |
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