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Randomized Trial of Adult Subjects With Generalized Anxiety Disorder

Sponsor
Biohaven Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03829241
Collaborator
(none)
402
Enrollment
54
Locations
2
Arms
14.6
Actual Duration (Months)
7.4
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy of BHV-4157 versus placebo in subjects with Generalized Anxiety Disorder.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
402 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Double-blind to Sponsor, Investigator and Subject
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial of Troriluzole in Generalized Anxiety Disorder
Actual Study Start Date :
Feb 19, 2019
Actual Primary Completion Date :
Jan 14, 2020
Actual Study Completion Date :
May 8, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1: BHV-4157- Experimental

Drug: Troriluzole
100mg capsule
Other Names:
  • BHV4157/Troriluzole 100mg PO

    		•
    Placebo Comparator: Arm 2: Placebo Comparator Drug

    Drug: Placebo
    100mg capsule
    Other Names:
  • Placebo 100mg PO

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The total score measured by the Hamilton Anxiety Rating Scale (HAM-A) [Change from Baseline to Week 8]

      a decreased score indicating a decrease in anxiety symptoms

    Secondary Outcome Measures

    1. Tolerability and safety of BHV-4157 will be measured by frequency and severity of adverse events and discontinuations of adverse events. [Baseline to Week 8]

    2. Change in the Sheehan Disability Scale (SDS) total score [Baseline to Week 8]

      higher total scores indicate more disability

    3. Change in the Clinical Global Impression of Severity Scale (CGI-S) [Baseline to Week 8]

      the higher score indicates more severe symptoms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    • HAM-A Total Score of ≥ 18 at both Screening and Baseline

    • 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. Subjects 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

    • Subjects 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:

    • Subjects with a primary DSM-V psychiatric disorder diagnosis other than GAD within the past 6-months. Note: Subjects 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

    • Subjects 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

    • Patients who report a history of inadequate response (per investigator judgement) to three (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

    • 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Woodland International Research Group Little Rock Arkansas United States 72211
    2 Axiom Research, LLC Colton California United States 92324
    3 Pharmacology Research Institute Encino California United States 91316
    4 University of California, San Francisco-Fresno Fresno California United States 93701
    5 Collaborative Neuroscience Network, LLC. Garden Grove California United States 92845
    6 Synergy San Diego Lemon Grove California United States 91945
    7 Pharmacology Research Institute Los Alamitos California United States 90720
    8 CalNeuro Research Group Los Angeles California United States 91423
    9 Pharmacology Research Institute Newport Beach California United States 92660
    10 Pacific Research Partners, LLC Oakland California United States 94607
    11 NRC Research Institute Orange California United States 92868
    12 Desert Valley Research Rancho Mirage California United States 92270
    13 Atemis Institute for Clinical Research San Marcos California United States 92078
    14 California Neuroscience Research Medical Group, Inc Sherman Oaks California United States 91403
    15 CNS Network Torrance California United States 90502
    16 Pacific Clinical Research Medical Group Upland California United States 91786
    17 Child Study Center at Yale University School of Medicine New Haven Connecticut United States 06519
    18 Comprehensive Psychiatric Care Norwich Connecticut United States 06360
    19 Meridien Research Bradenton Florida United States 34201
    20 Gulfcoast Clinical Research Center Fort Myers Florida United States 33912
    21 Galiz Research Hialeah Florida United States 33016
    22 Clinical Neuroscience Solutions, Inc Jacksonville Florida United States 32256
    23 Harmony Clinical Research North Miami Beach Florida United States 33162
    24 Clinical Neuroscience Solutions, Inc Orlando Florida United States 32801
    25 Stedman Clinical Trials Tampa Florida United States 33613
    26 iResearch Atlanta LLC Decatur Georgia United States 30030
    27 Northwest Behavioral Research Center Marietta Georgia United States 30060
    28 Phoenix Medical Research Prairie Village Kansas United States 66208
    29 Heartland Research Associates, LLC Wichita Kansas United States 67207
    30 Boston Clinical Trials Boston Massachusetts United States 02131
    31 BTC of New Bedford New Bedford Massachusetts United States 02740
    32 Altea Research Institute Las Vegas Nevada United States 89102
    33 Center for Emotional Fitness Cherry Hill New Jersey United States 08002
    34 Albuquerque Neuroscience Inc. Albuquerque New Mexico United States 87109
    35 SPRI Clinical Trials, LLC Brooklyn New York United States 11235
    36 Finger Lakes Clinical Research Rochester New York United States 14618
    37 Richmond Behavioral Associates Staten Island New York United States 10312
    38 New Hope Clinical Research Charlotte North Carolina United States 28211
    39 Midwest Clinical Research Center Dayton Ohio United States 45417
    40 IPS Research Company Oklahoma City Oklahoma United States 73106
    41 Summit Research Network (Oregon) Inc. Portland Oregon United States 97210
    42 Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.) Portland Oregon United States 97214
    43 Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.) Salem Oregon United States 97301
    44 Suburban Research Associates, Inc. Media Pennsylvania United States 19063
    45 Keystone Clinical Studies, LLC Norristown Pennsylvania United States 19403
    46 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    47 Volunteer Research Group, an AMR Company Knoxville Tennessee United States 37920
    48 Clinical Neuroscience Solutions, Inc Memphis Tennessee United States 38119
    49 FutureSearch Trials of Dallas, LP Dallas Texas United States 91316
    50 InSite Clinical Research DeSoto Texas United States 75249
    51 Baylor College of Medicine Houston Texas United States 77030
    52 Red Oak Psychiatry Associates, PA Houston Texas United States 77090
    53 Grayline Clinical Drug Trials Wichita Falls Texas United States 76309
    54 Northwest Clinical Research Center Bellevue Washington United States 98007

    Sponsors and Collaborators

    • Biohaven Pharmaceuticals, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biohaven Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT03829241
    Other Study ID Numbers:
    • BHV4157-207
    First Posted:
    Feb 4, 2019
    Last Update Posted:
    Jul 19, 2022
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Biohaven Pharmaceuticals, Inc.
    Generalized Anxiety Disorder (GAD)
    Additional relevant MeSH terms:
    Disease
    Anxiety Disorders

    Study Results

    No Results Posted as of Jul 19, 2022