Randomized Trial of Adult Participants With Generalized Anxiety Disorder
NCT ID: NCT03829241
Last Updated: 2024-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
881 participants
INTERVENTIONAL
2019-02-19
2020-05-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Troriluzole
100 mg capsule
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.
Troriluzole
100 mg capsule
Placebo
Placebo matched to troriluzole
Interventions
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Troriluzole
100 mg capsule
Placebo
Placebo matched to troriluzole
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Biohaven Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Woodland International Research Group
Little Rock, Arkansas, United States
Axiom Research, LLC
Colton, California, United States
Pharmacology Research Institute
Encino, California, United States
University of California, San Francisco-Fresno
Fresno, California, United States
Collaborative Neuroscience Network, LLC.
Garden Grove, California, United States
Synergy San Diego
Lemon Grove, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
CalNeuro Research Group
Los Angeles, California, United States
Pharmacology Research Institute
Newport Beach, California, United States
Pacific Research Partners, LLC
Oakland, California, United States
NRC Research Institute
Orange, California, United States
Desert Valley Research
Rancho Mirage, California, United States
Atemis Institute for Clinical Research
San Marcos, California, United States
California Neuroscience Research Medical Group, Inc
Sherman Oaks, California, United States
CNS Network
Torrance, California, United States
Pacific Clinical Research Medical Group
Upland, California, United States
Child Study Center at Yale University School of Medicine
New Haven, Connecticut, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, United States
Meridien Research
Bradenton, Florida, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States
Galiz Research
Hialeah, Florida, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, United States
Harmony Clinical Research
North Miami Beach, Florida, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
iResearch Atlanta LLC
Decatur, Georgia, United States
Northwest Behavioral Research Center
Marietta, Georgia, United States
Phoenix Medical Research
Prairie Village, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Boston Clinical Trials
Boston, Massachusetts, United States
BTC of New Bedford
New Bedford, Massachusetts, United States
Altea Research Institute
Las Vegas, Nevada, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
New Hope Clinical Research
Charlotte, North Carolina, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, United States
Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
Portland, Oregon, United States
Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
Salem, Oregon, United States
Suburban Research Associates, Inc.
Media, Pennsylvania, United States
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Volunteer Research Group, an AMR Company
Knoxville, Tennessee, United States
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BHV4157-207
Identifier Type: -
Identifier Source: org_study_id
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