Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the efficacy of troriluzole versus placebo in participants with generalized anxiety disorder.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Troriluzole | Experimental | Randomization phase (Weeks 1 through 8): Participants received troriluzole 100 mg capsules twice daily (BID) orally for up to 8 weeks in the double-blind (DB) randomization phase. Extension phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed open-label (OL) treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks. |
|
| Placebo | Placebo Comparator | Randomization Phase (Weeks 1 through 8): Participants received troriluzole matching placebo capsules BID orally for up to 8 weeks in the DB randomization phase. Extension Phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed OL treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Troriluzole | Drug | 100 mg capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the HAM-A Total Score at Week 8 | The HAM-A was an investigator-administered scale and consisted of 14 items: anxious mood, tension, fears, insomnia, concentration, depressed mood, behavior at interview, somatic muscular, somatic sensory, cardiovascular, respiratory, gastrointestinal, genitourinary, and autonomic symptoms. Each item was scored on a scale of 0 (not present) to 4 (severe) with a total score range of 0-56. A decreased score indicated a decrease in anxiety symptoms. | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Medication During Randomized Phase | A serious adverse event (SAE) was defined as any event that met any of the following criteria: 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 rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention. Treatment-emergent AEs (TEAEs) in the randomization phase included any adverse event (AE) with an onset date on or after the first day of double-blind study drug and up to the first day of open-label study drug in the extension phase (for participants entering the extension phase) or last day of the randomization phase study drug + 30 days. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland International Research Group | Little Rock | Arkansas | 72211 | United States | ||
| Axiom Research, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 881 participants were enrolled, of which 402 participants were randomized in a 1:1: ratio to receive troriluzole or placebo. 479 participants were not randomized due to withdrawal of concent, lost to follow-up, failed inclusion/exclusion criteria, or other reasons.
The study was conducted at 53 sites in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Troriluzole | Randomization phase (Weeks 1 through 8): Participants received troriluzole 100 mg capsules twice daily (BID) orally for up to 8 weeks in the double-blind (DB) randomization phase. Extension phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed open-label (OL) treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomization Phase (Week 1 to Week 8) |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 1, 2019 | Dec 3, 2022 |
Not provided
Not provided
Not provided
Not provided
Double-blind to Sponsor, Investigator and Subject
| Placebo | Drug | Placebo matched to troriluzole |
|
| From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) |
| Number of Participants With Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Drug During Extension Phase | An SAE was defined as any event that met any of the following criteria: 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 rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention. TEAEs in the extension phase included any AE with an onset date on or after the first day of the study drug in the extension phase and up to the last day of the study drug in the extension phase + 30 days. | From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days) |
| Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Clinically significant laboratory abnormalities were defined as Grade 3 to 4 laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events (CTCAE) Version 5.0 (2017) or the Division of Acquired Immune Deficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017), where Grade 3=Severe and Grade 4=Potentially Life Threatening. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. | From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) |
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 | 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 (SDS total score) that ranged from 0 (unimpaired) to 30 (highly impaired). | Baseline, Week 8 |
| Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score at Week 8 | Participants rated on the seven-point severity of Illness with severity of wherein 1 = normal, not at all; 2= borderline ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7 = among the most extremely ill participants. | Baseline, Week 8 |
| Colton |
| California |
| 92324 |
| United States |
| Pharmacology Research Institute | Encino | California | 91316 | United States |
| University of California, San Francisco-Fresno | Fresno | California | 93701 | United States |
| Collaborative Neuroscience Network, LLC. | Garden Grove | California | 92845 | United States |
| Synergy San Diego | Lemon Grove | California | 91945 | United States |
| Pharmacology Research Institute | Los Alamitos | California | 90720 | United States |
| CalNeuro Research Group | Los Angeles | California | 91423 | United States |
| Pharmacology Research Institute | Newport Beach | California | 92660 | 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 |
| Atemis Institute for Clinical Research | San Marcos | California | 92078 | United States |
| California Neuroscience Research Medical Group, Inc | Sherman Oaks | California | 91403 | United States |
| CNS Network | Torrance | California | 90502 | United States |
| Pacific Clinical Research Medical Group | Upland | California | 91786 | United States |
| Child Study Center at Yale University School of Medicine | New Haven | Connecticut | 06519 | United States |
| Comprehensive Psychiatric Care | Norwich | Connecticut | 06360 | United States |
| Meridien Research | Bradenton | Florida | 34201 | United States |
| Gulfcoast Clinical Research Center | Fort Myers | Florida | 33912 | United States |
| Galiz Research | Hialeah | Florida | 33016 | United States |
| Clinical Neuroscience Solutions, Inc | Jacksonville | Florida | 32256 | United States |
| Harmony Clinical Research | North Miami Beach | Florida | 33162 | United States |
| Clinical Neuroscience Solutions, Inc | Orlando | Florida | 32801 | United States |
| Stedman Clinical Trials | Tampa | Florida | 33613 | United States |
| iResearch Atlanta LLC | Decatur | Georgia | 30030 | United States |
| Northwest Behavioral Research Center | Marietta | Georgia | 30060 | United States |
| Phoenix Medical Research | Prairie Village | Kansas | 66208 | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| BTC of New Bedford | New Bedford | Massachusetts | 02740 | United States |
| Altea Research Institute | Las Vegas | Nevada | 89102 | United States |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | United States |
| Albuquerque Neuroscience Inc. | Albuquerque | New Mexico | 87109 | United States |
| SPRI Clinical Trials, LLC | Brooklyn | New York | 11235 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| New Hope Clinical Research | Charlotte | North Carolina | 28211 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73106 | United States |
| Summit Research Network (Oregon) Inc. | Portland | Oregon | 97210 | United States |
| Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.) | Portland | Oregon | 97214 | United States |
| Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.) | Salem | Oregon | 97301 | United States |
| Suburban Research Associates, Inc. | Media | Pennsylvania | 19063 | United States |
| Keystone Clinical Studies, LLC | Norristown | Pennsylvania | 19403 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Volunteer Research Group, an AMR Company | Knoxville | Tennessee | 37920 | United States |
| Clinical Neuroscience Solutions, Inc | Memphis | Tennessee | 38119 | United States |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 91316 | United States |
| InSite Clinical Research | DeSoto | Texas | 75249 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | United States |
| Grayline Clinical Drug Trials | Wichita Falls | Texas | 76309 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| FG001 | Placebo | Randomization Phase (Weeks 1 through 8): Participants received troriluzole matching placebo capsules BID orally for up to 8 weeks in the DB randomization phase. Extension Phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed OL treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks. |
| 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 |
|
|
| Extension Phase (Week 9 up to Week 48) |
|
|
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 |
|---|---|---|
| BG000 | Troriluzole | Randomization phase (Weeks 1 through 8): Participants received troriluzole 100 mg capsules BID orally for up to 8 weeks in the DB randomization phase. Extension phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed OL treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks. |
| BG001 | Placebo | Randomization Phase (Weeks 1 through 8): Participants received troriluzole matching placebo capsules BID orally for up to 8 weeks in the DB randomization phase. Extension Phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed OL treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Hamilton Anxiety Rating Scale (HAM-A): Total score | The HAM-A is a investigator-administered scale designed to rate the severity of anxiety as well as the type of symptoms in participants with GAD. The scale consisted of 14 items: anxious mood, tension, fears, insomnia, concentration, depressed mood, behavior at interview, somatic muscular, somatic sensory, cardiovascular, respiratory, gastrointestinal, genitourinary, and autonomic symptoms. Each item was scored on a scale of 0 (not present) to 4 (severe) with a total score range of 0-56. a decreased score indicating a decrease in anxiety symptoms. | Mean | Standard Deviation | score 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 HAM-A Total Score at Week 8 | The HAM-A was an investigator-administered scale and consisted of 14 items: anxious mood, tension, fears, insomnia, concentration, depressed mood, behavior at interview, somatic muscular, somatic sensory, cardiovascular, respiratory, gastrointestinal, genitourinary, and autonomic symptoms. Each item was scored on a scale of 0 (not present) to 4 (severe) with a total score range of 0-56. A decreased score indicated a decrease in anxiety symptoms. | The mITT participants in the randomization phase (randomized participants who received at least 1 dose of blinded study therapy [troriluzole or placebo], and provided a non-missing baseline assessment and at least 1 non-missing post-baseline efficacy assessment during the randomization phase) were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Week 8 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Medication During Randomized Phase | A serious adverse event (SAE) was defined as any event that met any of the following criteria: 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 rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention. Treatment-emergent AEs (TEAEs) in the randomization phase included any adverse event (AE) with an onset date on or after the first day of double-blind study drug and up to the first day of open-label study drug in the extension phase (for participants entering the extension phase) or last day of the randomization phase study drug + 30 days. | Treated participants in the randomization phase: Enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). | Posted | Count of Participants | Participants | No | From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Drug During Extension Phase | An SAE was defined as any event that met any of the following criteria: 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 rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention. TEAEs in the extension phase included any AE with an onset date on or after the first day of the study drug in the extension phase and up to the last day of the study drug in the extension phase + 30 days. | Treated participants in the extension phase: Treated participants in the randomization phase who received at least 1 dose of troriluzole in the open-label (OL) extension phase. | Posted | Count of Participants | Participants | No | From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Clinically significant laboratory abnormalities were defined as Grade 3 to 4 laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events (CTCAE) Version 5.0 (2017) or the Division of Acquired Immune Deficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017), where Grade 3=Severe and Grade 4=Potentially Life Threatening. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. | Treated participants in the randomization phase with available data were analyzed. | Posted | Count of Participants | Participants | No | From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 | 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 (SDS total score) that ranged from 0 (unimpaired) to 30 (highly impaired). | The mITT participants in the randomization phase with available data were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score at Week 8 | Participants rated on the seven-point severity of Illness with severity of wherein 1 = normal, not at all; 2= borderline ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7 = among the most extremely ill participants. | The mITT participants in the randomization phase were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Week 8 |
|
|
Randmization Phase: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) Extension Phase: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Randomization phase: Treated participants in the randomization phase - enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
Extension phase: Treated participants in the extension phase - treated participants in the randomization phase who received at least 1 dose of troriluzole in the OL extension phase.
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 8): Participants received troriluzole 100 mg capsules BID orally for up to 8 weeks in the DB randomization phase. | 0 | 199 | 0 | 199 | 43 | 199 |
| EG001 | Placebo - Randomization Phase | Randomization Phase (Weeks 1 through 8): Participants received troriluzole matching placebo capsules BID orally for up to 8 weeks in the DB randomization phase. | 0 | 191 | 0 | 191 | 36 | 191 |
| EG002 | Troriluzole - Randomization Phase/Troriluzole - Extension Phase | Extension phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed open-label (OL) treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks. | 0 | 153 | 3 | 153 | 28 | 153 |
| EG003 | Placebo - Randomization Phase/Troriluzole - Extension Phase | Extension Phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed OL treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks. | 0 | 149 | 1 | 149 | 30 | 149 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocarditis | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Gallbladder adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
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 | Jan 22, 2020 | Dec 3, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Physician Decision |
|
| Sponsor Request |
|
| Significant Protocol Violation |
|
| Adverse Event |
|
| Non compliance |
|
| Pregnancy |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Placebo |
Randomization Phase (Weeks 1 through 8): Participants received troriluzole matching placebo capsules BID orally for up to 8 weeks in the DB randomization phase. |
|
|
| OG001 | Placebo | Extension Phase (Weeks 9 through 56): Participants, who completed the randomization phase and for whom the investigator believed OL treatment could offer an acceptable risk-benefit profile, entered the extension phase and received OL troriluzole capsules (continuing on the same dose and regimen that was taken at the end of the randomization phase) for up to additional 48 weeks. |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|