Randomized Trial of Adult Participants With Generalized Anxiety Disorder

NCT03829241 | Completed Phase 3 Results FDA Drug

• 1 other identifier: BHV4157-207
• Study Type: interventional
• Target: 881
• Locations: 1 country
• Sites: 53

Brief Summary

The purpose of this study is to compare the efficacy of troriluzole versus placebo in participants with generalized anxiety disorder.

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder (GAD)

Outcome Measures

Primary Outcomes (1)

• 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

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

  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

  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

  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

  Baseline, Week 8

• Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score at Week 8

  Baseline, Week 8

Study Arms (2)

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.

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.

Drug: Troriluzole; Drug: Placebo

Interventions

Troriluzole DRUG

100 mg capsule

Also known as: BHV-4157

Placebo; Troriluzole

Placebo DRUG

Placebo matched to troriluzole

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• Biohaven Pharmaceuticals, Inc.: lead

Study Sites (53)

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Axiom Research, LLC

Colton, California, 92324, United States

Location

Pharmacology Research Institute

Encino, California, 91316, United States

Location

University of California, San Francisco-Fresno

Fresno, California, 93701, United States

Location

Collaborative Neuroscience Network, LLC.

Garden Grove, California, 92845, United States

Location

Synergy San Diego

Lemon Grove, California, 91945, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

CalNeuro Research Group

Los Angeles, California, 91423, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

Pacific Research Partners, LLC

Oakland, California, 94607, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

Desert Valley Research

Rancho Mirage, California, 92270, United States

Location

Atemis Institute for Clinical Research

San Marcos, California, 92078, United States

Location

California Neuroscience Research Medical Group, Inc

Sherman Oaks, California, 91403, United States

Location

CNS Network

Torrance, California, 90502, United States

Location

Pacific Clinical Research Medical Group

Upland, California, 91786, United States

Location

Child Study Center at Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Comprehensive Psychiatric Care

Norwich, Connecticut, 06360, United States

Location

Meridien Research

Bradenton, Florida, 34201, United States

Location

Gulfcoast Clinical Research Center

Fort Myers, Florida, 33912, United States

Location

Galiz Research

Hialeah, Florida, 33016, United States

Location

Clinical Neuroscience Solutions, Inc

Jacksonville, Florida, 32256, United States

Location

Harmony Clinical Research

North Miami Beach, Florida, 33162, United States

Location

Clinical Neuroscience Solutions, Inc

Orlando, Florida, 32801, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

iResearch Atlanta LLC

Decatur, Georgia, 30030, United States

Location

Northwest Behavioral Research Center

Marietta, Georgia, 30060, United States

Location

Phoenix Medical Research

Prairie Village, Kansas, 66208, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

BTC of New Bedford

New Bedford, Massachusetts, 02740, United States

Location

Altea Research Institute

Las Vegas, Nevada, 89102, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Albuquerque Neuroscience Inc.

Albuquerque, New Mexico, 87109, United States

Location

SPRI Clinical Trials, LLC

Brooklyn, New York, 11235, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

New Hope Clinical Research

Charlotte, North Carolina, 28211, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73106, United States

Location

Summit Research Network (Oregon) Inc.

Portland, Oregon, 97210, United States

Location

Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)

Portland, Oregon, 97214, United States

Location

Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)

Salem, Oregon, 97301, United States

Location

Suburban Research Associates, Inc.

Media, Pennsylvania, 19063, United States

Location

Keystone Clinical Studies, LLC

Norristown, Pennsylvania, 19403, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Volunteer Research Group, an AMR Company

Knoxville, Tennessee, 37920, United States

Location

Clinical Neuroscience Solutions, Inc

Memphis, Tennessee, 38119, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 91316, United States

Location

InSite Clinical Research

DeSoto, Texas, 75249, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Red Oak Psychiatry Associates, PA

Houston, Texas, 77090, United States

Location

Grayline Clinical Drug Trials

Wichita Falls, Texas, 76309, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Biohaven Pharmaceuticals, Inc.

clinicaltrials@biohavenpharma.com

203-404-0410

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind to Sponsor, Investigator and Subject
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 4, 2019
• Study Start: February 19, 2019
• Primary Completion: January 14, 2020
• Study Completion: May 8, 2020
• Last Updated: May 8, 2024
• Results First Posted: December 28, 2022

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (53)