Randomized Trial of Adult Subjects With Generalized Anxiety Disorder

Overview

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

Full Title of Study: “A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial of Troriluzole in Generalized Anxiety Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: January 10, 2020

Interventions

  • Drug: Troriluzole
    • 100mg capsule
  • Drug: Placebo
    • 100mg capsule

Arms, Groups and Cohorts

  • Experimental: Arm 1: BHV-4157- Experimental
  • Placebo Comparator: Arm 2: Placebo Comparator Drug

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • Change in the Sheehan Disability Scale (SDS) total score
    • Time Frame: Baseline to Week 8
    • higher total scores indicate more disability
  • Change in the Clinical Global Impression of Severity Scale (CGI-S)
    • Time Frame: Baseline to Week 8
    • the higher score indicates more severe symptoms

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Biohaven Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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