Randomized Trial of Adult Participants With Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Troriluzole; Placebo
Intervention description: 100 mg capsule; Placebo matched to troriluzole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double-blind to Sponsor, Investigator and Subject
Enrollment: 881.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Generalized Anxiety Disorder (GAD)

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

Eligibility criteria:

        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

          -  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

        Exclusion Criteria:

          -  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 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

          -  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)