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Randomized Trial of Adult Subjects With Generalized Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03829241
Recruitment Status : Active, not recruiting
First Posted : February 4, 2019
Last Update Posted : February 7, 2020
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

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
Generalized Anxiety Disorder Drug: Troriluzole Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
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 : February 19, 2019
Actual Primary Completion Date : January 10, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Arm 1: BHV-4157- Experimental Drug: Troriluzole
100mg capsule
Other Name: BHV4157/Troriluzole 100mg PO

Placebo Comparator: Arm 2: Placebo Comparator Drug Drug: Placebo
100mg capsule
Other Name: Placebo 100mg PO

Primary Outcome Measures :
  1. The total score measured by the Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: 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. [ Time Frame: Baseline to Week 8 ]
  2. Change in the Sheehan Disability Scale (SDS) total score [ Time Frame: Baseline to Week 8 ]
    higher total scores indicate more disability

  3. Change in the Clinical Global Impression of Severity Scale (CGI-S) [ Time Frame: Baseline to Week 8 ]
    the higher score indicates more severe symptoms

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03829241

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Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.
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Responsible Party: Biohaven Pharmaceuticals, Inc. Identifier: NCT03829241    
Other Study ID Numbers: BHV4157-207
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Anxiety Disorders
Pathologic Processes
Mental Disorders