Generalized Anxiety Disorder
Conditions
Keywords
Generalized Anxiety Disorder (GAD)
Brief summary
The purpose of this study is to compare the efficacy of troriluzole versus placebo in participants with generalized anxiety disorder.
Interventions
DRUGTroriluzole
100 mg capsule
DRUGPlacebo
Placebo matched to troriluzole
Sponsors
Biohaven Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-blind to Sponsor, Investigator and Subject
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Primary diagnosis of generalized anxiety disorder (GAD) either moderate or severe as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) as confirmed by the MINI at Screening, in addition to a psychiatric evaluation by a board- certified or Biohaven-approved board-eligible psychiatrist; The duration of illness must be ≥ 1 year * Hamilton Anxiety Rating Scale (HAM-A) Total Score of ≥ 18 at both Screening and Baseline * Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 4 at both Screening and Baseline * 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 to complete necessary scales and understand consent forms * 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 * Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing at Baseline
Exclusion criteria
* Participants with a primary DSM-V psychiatric disorder diagnosis other than GAD within the past 6-months. Note: Participants with a secondary diagnosis of comorbid social anxiety disorder or specific phobia are allowed, if in the investigator's judgement, the diagnosis is not sufficiently prominent and active so as to be confound the assessment of GAD symptoms * Participants should be excluded at screening or baseline if any medical or psychiatric condition other than GAD, as specified in the inclusion criteria, could predominantly explain or contribute significantly to the subjects' symptoms or that could confound assessment of GAD symptoms * Participants who report a history of inadequate response (per investigator judgement) to 3 or more adequate trials (including current trial) of any SSRI or SNRI, at an adequate dose and adequate duration (at least 8 weeks) for the treatment of GAD within the 3 years prior to randomization * Hamilton Depression Rating Scale 17 (HAM-D-17) item 1 of \>1 at Screening or Baseline * HAM-D-17 of \> 19 at Baseline * Any eating disorder within the last 12 months prior to Screening * Acute suicidality in the last 12 months, or suicide attempt or self-injurious behavior in the last 12 months prior to Screening * Score of \>0 on the Sheehan Suicidality Tracking Scale for the period of 12 months prior to screening, and at baseline * History of psychosurgery, deep brain stimulation (DBS) or electroconvulsive therapy (ECT)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the HAM-A Total Score at Week 8 | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) | 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. |
| Number of Participants With Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Drug During Extension Phase | From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days) | 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. |
| Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) | 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. |
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 | Baseline, 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). |
| Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score at Week 8 | Baseline, 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. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 53 sites in the United States.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 199 |
| 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. | 191 |
| Total | 390 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Extension Phase (Week 9 up to Week 48) | Adverse Event | 11 | 11 |
| Extension Phase (Week 9 up to Week 48) | Lost to Follow-up | 9 | 7 |
| Extension Phase (Week 9 up to Week 48) | Non compliance | 1 | 1 |
| Extension Phase (Week 9 up to Week 48) | Physician Decision | 1 | 0 |
| Extension Phase (Week 9 up to Week 48) | Pregnancy | 0 | 2 |
| Extension Phase (Week 9 up to Week 48) | Significant Protocol Violation | 0 | 1 |
| Extension Phase (Week 9 up to Week 48) | Sponsor Request | 117 | 108 |
| Extension Phase (Week 9 up to Week 48) | Withdrawal of Consent | 20 | 24 |
| Randomization Phase (Week 1 to Week 8) | Adverse Event | 8 | 9 |
| Randomization Phase (Week 1 to Week 8) | Lost to Follow-up | 5 | 11 |
| Randomization Phase (Week 1 to Week 8) | Non compliance | 2 | 1 |
| Randomization Phase (Week 1 to Week 8) | Pregnancy | 0 | 1 |
| Randomization Phase (Week 1 to Week 8) | Sponsor Request | 0 | 1 |
| Randomization Phase (Week 1 to Week 8) | Withdrawal of Consent | 16 | 19 |
Baseline characteristics
| Characteristic | Placebo | Total | Troriluzole |
|---|---|---|---|
| Age, Continuous | 37.5 years STANDARD_DEVIATION 12.59 | 38.0 years STANDARD_DEVIATION 12.65 | 38.4 years STANDARD_DEVIATION 12.72 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 36 Participants | 65 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 155 Participants | 325 Participants | 170 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hamilton Anxiety Rating Scale (HAM-A): Total score | 24.1 score on a scale STANDARD_DEVIATION 3.8 | 24.4 score on a scale STANDARD_DEVIATION 4.08 | 24.7 score on a scale STANDARD_DEVIATION 4.34 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 18 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 55 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 151 Participants | 302 Participants | 151 Participants |
| Sex: Female, Male Female | 147 Participants | 299 Participants | 152 Participants |
| Sex: Female, Male Male | 44 Participants | 91 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 199 | 0 / 191 | 0 / 153 | 0 / 149 |
| other Total, other adverse events | 43 / 199 | 36 / 191 | 28 / 153 | 30 / 149 |
| serious Total, serious adverse events | 0 / 199 | 0 / 191 | 3 / 153 | 1 / 149 |
Outcome results
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.
Time frame: Baseline, Week 8
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Troriluzole | Change From Baseline in the HAM-A Total Score at Week 8 | -9.28 score on a scale |
| Placebo | Change From Baseline in the HAM-A Total Score at Week 8 | -9.35 score on a scale |
Comparison: Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect.p-value: 0.91795% CI: [-1.45, 1.3]Mixed Models Analysis
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.
Time frame: Baseline, Week 8
Population: The mITT participants in the randomization phase were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Troriluzole | Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score at Week 8 | -1.19 score on a scale |
| Placebo | Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score at Week 8 | -1.21 score on a scale |
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).
Time frame: Baseline, Week 8
Population: The mITT participants in the randomization phase with available data were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Troriluzole | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 | -5.78 score on a scale |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 | -5.53 score on a scale |
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.
Time frame: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks)
Population: Treated participants in the randomization phase with available data were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Glucose, high | 1 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Leukocytes | 0 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Lymphocytes, low | 0 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Lymphocytes, high | 0 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Neutrophils | 0 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Platelets | 0 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Alanine Aminotransferase | 1 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Albumin | 0 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Alkaline Phosphatase | 0 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Aspartate Aminotransferase | 2 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Bicarbonate | 0 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Bilirubin | 0 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Calcium, low | 0 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Calcium, high | 0 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Creatine Kinase | 3 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Creatinine | 0 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Sodium, low | 0 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Urine Glucose | 0 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Glucose, low | 0 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Hemoglobin | 0 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Lactate Dehydrogenase | 0 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Potassium, low | 0 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Potassium, high | 1 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Sodium, high | 0 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Urate | 1 Participants |
| Troriluzole | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Urine Protein | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Urine Protein | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Hemoglobin | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Calcium, high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Leukocytes | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Glucose, high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Lymphocytes, low | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Creatine Kinase | 1 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Lymphocytes, high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Urate | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Neutrophils | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Creatinine | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Platelets | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Potassium, high | 1 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Alanine Aminotransferase | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Lactate Dehydrogenase | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Albumin | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Sodium, low | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Sodium, high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Alkaline Phosphatase | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Aspartate Aminotransferase | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Urine Glucose | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Bicarbonate | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Potassium, low | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Bilirubin | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Glucose, low | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase | Calcium, low | 0 Participants |
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.
Time frame: From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Troriluzole | Number of Participants With Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Drug During Extension Phase | Participants with at least 1 serious TEAE | 3 Participants |
| Troriluzole | Number of Participants With Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Drug During Extension Phase | Participants with at least 1 TEAE leading to withdrawal from study drug | 9 Participants |
| Troriluzole | Number of Participants With Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Drug During Extension Phase | Participants with at least 1 TEAE related to study medication | 29 Participants |
| Placebo | Number of Participants With Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Drug During Extension Phase | Participants with at least 1 serious TEAE | 1 Participants |
| Placebo | Number of Participants With Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Drug During Extension Phase | Participants with at least 1 TEAE related to study medication | 27 Participants |
| Placebo | Number of Participants With Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Drug During Extension Phase | Participants with at least 1 TEAE leading to withdrawal from study drug | 12 Participants |
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.
Time frame: From first dose to Week 8 plus 30 days (maximum duration: 12 weeks)
Population: Treated participants in the randomization phase: Enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Troriluzole | 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 | Participants with at least 1 TEAE related to study medication | 59 Participants |
| Troriluzole | 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 | Participants with at least 1 TEAE leading to withdrawal from study drug | 11 Participants |
| Troriluzole | 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 | Participants with at least 1 serious TEAE | 0 Participants |
| Placebo | 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 | Participants with at least 1 serious TEAE | 0 Participants |
| Placebo | 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 | Participants with at least 1 TEAE related to study medication | 47 Participants |
| Placebo | 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 | Participants with at least 1 TEAE leading to withdrawal from study drug | 11 Participants |