Trial · NCT03829241
Randomized Trial of Adult Participants With Generalized Anxiety Disorder
NCT03829241, Phase 3, Completed, Biohaven Pharmaceuticals, Inc.; results first posted 2022-12-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized Trial of Adult Participants With Generalized Anxiety Disorder. Trials, record NCT03829241. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03829241
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Trial of Adult Participants With Generalized Anxiety Disorder
- NCT number
- NCT03829241
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 881 participants, actual
- Lead sponsor
- Biohaven Pharmaceuticals, Inc.
- Conditions
- Generalized Anxiety Disorder
- Interventions
- Troriluzole, Placebo
- First posted
- 2019-02-04
- Last updated
- 2024-05-08
- Results first posted
- 2022-12-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the HAM-A Total Score at Week 8 | Baseline, Week 8 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| 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 | From first dose to Week 8 plus 30 days (maximum duration: 12 weeks) | Treated participants in the randomization phase: Enrolled participants who received at least 1 dose of blinded study therapy (troriluzole or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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) | Treated participants in the randomization phase with available data were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 | Baseline, Week 8 | The mITT participants in the randomization phase with available data were analyzed. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score at Week 8 | Baseline, Week 8 | The mITT participants in the randomization phase were analyzed. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the HAM-A Total Score at Week 8 | Troriluzole | -9.28 | 95% Confidence Interval -10.23 to -8.32 | score on a scale | |
| Change From Baseline in the HAM-A Total Score at Week 8 | Placebo | -9.35 | 95% Confidence Interval -10.34 to -8.36 | score on a scale | |
| 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 | Troriluzole | Participants with at least 1 serious TEAE | 0 | Participants | |
| 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 | Placebo | Participants with at least 1 serious TEAE | 0 | Participants | |
| 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 | Troriluzole | Participants with at least 1 TEAE related to study medication | 59 | Participants | |
| 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 | Placebo | Participants with at least 1 TEAE related to study medication | 47 | Participants | |
| 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 | Troriluzole | Participants with at least 1 TEAE leading to withdrawal from study drug | 11 | Participants | |
| 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 | Placebo | Participants with at least 1 TEAE leading to withdrawal from study drug | 11 | Participants | |
| Number of Participants With Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Drug During Extension Phase | Troriluzole | Participants with at least 1 serious TEAE | 3 | Participants | |
| Number of Participants With Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Drug During Extension Phase | Placebo | Participants with at least 1 serious TEAE | 1 | Participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization Phase (Week 1 to Week 8) | STARTED | Troriluzole | 202 | |
| Randomization Phase (Week 1 to Week 8) | STARTED | Placebo | 200 | |
| Randomization Phase (Week 1 to Week 8) | Treated | Troriluzole | 199 | |
| Randomization Phase (Week 1 to Week 8) | Treated | Placebo | 191 | |
| Randomization Phase (Week 1 to Week 8) | Modified Intent-to- Treat (mITT) Participants | Troriluzole | 198 | |
| Randomization Phase (Week 1 to Week 8) | Modified Intent-to- Treat (mITT) Participants | Placebo | 187 | |
| Randomization Phase (Week 1 to Week 8) | COMPLETED | Troriluzole | 171 | |
| Randomization Phase (Week 1 to Week 8) | COMPLETED | Placebo | 158 | |
| Randomization Phase (Week 1 to Week 8) | NOT COMPLETED | Troriluzole | 31 | |
| Randomization Phase (Week 1 to Week 8) | NOT COMPLETED | Placebo | 42 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Troriluzole - Randomization Phase | 17 | 199 | |
| other | Nausea | Gastrointestinal disorders | Placebo - Randomization Phase | 16 | 191 | |
| other | Nausea | Gastrointestinal disorders | Troriluzole - Randomization Phase/Troriluzole - Extension Phase | 3 | 153 | |
| other | Nausea | Gastrointestinal disorders | Placebo - Randomization Phase/Troriluzole - Extension Phase | 3 | 149 | |
| other | Headache | Nervous system disorders | Troriluzole - Randomization Phase | 8 | 199 | |
| other | Headache | Nervous system disorders | Placebo - Randomization Phase | 12 | 191 | |
| other | Headache | Nervous system disorders | Troriluzole - Randomization Phase/Troriluzole - Extension Phase | 7 | 153 | |
| other | Headache | Nervous system disorders | Placebo - Randomization Phase/Troriluzole - Extension Phase | 2 | 149 | |
| other | Fatigue | General disorders | Troriluzole - Randomization Phase | 10 | 199 | |
| other | Fatigue | General disorders | Placebo - Randomization Phase | 9 | 191 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Troriluzole - Randomization Phase | 0 | 199 |
| Total, all-cause mortality | Placebo - Randomization Phase | 0 | 191 |
| Total, all-cause mortality | Troriluzole - Randomization Phase/Troriluzole - Extension Phase | 0 | 153 |
| Total, all-cause mortality | Placebo - Randomization Phase/Troriluzole - Extension Phase | 0 | 149 |
| Total, other adverse events | Troriluzole - Randomization Phase | 43 | 199 |
| Total, other adverse events | Placebo - Randomization Phase | 36 | 191 |
| Total, other adverse events | Troriluzole - Randomization Phase/Troriluzole - Extension Phase | 28 | 153 |
| Total, other adverse events | Placebo - Randomization Phase/Troriluzole - Extension Phase | 30 | 149 |
| Total, serious adverse events | Troriluzole - Randomization Phase | 0 | 199 |
| Total, serious adverse events | Placebo - Randomization Phase | 0 | 191 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03829241
GET https://conductscience.org/api/trials/v1/NCT03829241/results?page=2