Generalized Anxiety DisorderPhase 3NCT03829241
Randomized Trial of Adult Participants With Generalized Anxiety Disorder
A Phase 3 study testing Troriluzole in people with Generalized Anxiety Disorder, run by Biohaven Pharmaceuticals, Inc. at 53 sites in United States.
Trial summary
The purpose of this study is to compare the efficacy of troriluzole versus placebo in participants with generalized anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Troriluzole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 881 participants
- Where
- 53 sitesUnited States
- Study dates
- 19 Feb 2019to 8 May 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, 87109
Northwest Clinical Research Center
Bellevue, Washington, 98007
Boston Clinical Trials
Boston, Massachusetts, 02131
Meridien Research
Bradenton, Florida, 34201
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235
New Hope Clinical Research
Charlotte, North Carolina, 28211
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
Axiom Research, LLC
Colton, California, 92324
FutureSearch Trials of Dallas, LP
Dallas, Texas, 91316
Midwest Clinical Research Center
Dayton, Ohio, 45417
iResearch Atlanta LLC
Decatur, Georgia, 30030
InSite Clinical Research
DeSoto, Texas, 75249
Pharmacology Research Institute
Encino, California, 91316
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912
University of California, San Francisco-Fresno
Fresno, California, 93701
Collaborative Neuroscience Network, LLC.
Garden Grove, California, 92845
Galiz Research
Hialeah, Florida, 33016
Baylor College of Medicine
Houston, Texas, 77030
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256
Volunteer Research Group, an AMR Company
Knoxville, Tennessee, 37920
Altea Research Institute
Las Vegas, Nevada, 89102
Synergy San Diego
Lemon Grove, California, 91945
Woodland International Research Group
Little Rock, Arkansas, 72211
Pharmacology Research Institute
Los Alamitos, California, 90720
CalNeuro Research Group
Los Angeles, California, 91423
Northwest Behavioral Research Center
Marietta, Georgia, 30060
Suburban Research Associates, Inc.
Media, Pennsylvania, 19063
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, 38119
BTC of New Bedford
New Bedford, Massachusetts, 02740
Child Study Center at Yale University School of Medicine
New Haven, Connecticut, 06519
Pharmacology Research Institute
Newport Beach, California, 92660
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, 19403
Harmony Clinical Research
North Miami Beach, Florida, 33162
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360
Pacific Research Partners, LLC
Oakland, California, 94607
IPS Research Company
Oklahoma City, Oklahoma, 73106
NRC Research Institute
Orange, California, 92868
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Summit Research Network (Oregon) Inc.
Portland, Oregon, 97210
Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
Portland, Oregon, 97214
Phoenix Medical Research
Prairie Village, Kansas, 66208
Desert Valley Research
Rancho Mirage, California, 92270
Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
Salem, Oregon, 97301
Atemis Institute for Clinical Research
San Marcos, California, 92078
California Neuroscience Research Medical Group, Inc
Sherman Oaks, California, 91403
Richmond Behavioral Associates
Staten Island, New York, 10312
Stedman Clinical Trials
Tampa, Florida, 33613
CNS Network
Torrance, California, 90502
Pacific Clinical Research Medical Group
Upland, California, 91786
Heartland Research Associates, LLC
Wichita, Kansas, 67207
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial of Troriluzole in Generalized Anxiety Disorder
The purpose of this study is to compare the efficacy of troriluzole versus placebo in participants with generalized anxiety disorder.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Troriluzole, Placebo
- Keywords
- Generalized Anxiety Disorder (GAD)
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TroriluzoleDrug
Also called BHV-4157
100 mg capsule
PlaceboDrug
Placebo matched to troriluzole
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Troriluzole |
| 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. Receives: Drug: Troriluzole; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 8
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start19 Feb 2019
- Primary completion14 Jan 2020
- Study completion8 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 881 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biohaven Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829241
- Sponsor's protocol ID
- BHV4157-207
- Status last verified
- May 2024
- First submitted
- 1 Feb 2019
- Last updated
- 8 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial of Troriluzole in Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT03829241
- Acronym / sponsor ID
- BHV4157-207
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized Anxiety Disorder (GAD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 881 participants (actual)
- Lead sponsor
- Biohaven Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 8 May 2020 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Posted 28 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy of troriluzole versus placebo in participants with generalized anxiety disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Troriluzole | Experimental | Drug: TroriluzoleRandomization 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 | Drug: Troriluzole, Drug: PlaceboRandomization 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TroriluzoleAlso: BHV-4157100 mg capsule | Drug | Placebo, Troriluzole |
| PlaceboPlacebo matched to troriluzole | Drug | Placebo |
Primary outcome
Change From Baseline in the HAM-A Total Score at Week 8
Time frame: 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.
5 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 8
Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score at Week 8
Time frame: Baseline, Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Troriluzole in people with Generalized Anxiety Disorder, run by Biohaven Pharmaceuticals, Inc. at 53 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the HAM-A Total Score at Week 8 (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.