Randomized Trial of Adult Participants With Generalized Anxiety Disorder

Generalized Anxiety Disorder Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial of Troriluzole in Generalized Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03829241
• Other study ID #: BHV4157-207
• Status: Completed
• Phase: Phase 3
• Start date: February 19, 2019
• Est. completion date: May 8, 2020

Study information

• Verified date: December 2022
• Source: Biohaven Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 881
• Est. completion date: May 8, 2020
• Est. primary completion date: January 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder

Intervention

Drug:
• Troriluzole
100 mg capsule
• Placebo
Placebo matched to troriluzole

Locations

Country	Name	City	State
United States	Albuquerque Neuroscience Inc.	Albuquerque	New Mexico
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Meridien Research	Bradenton	Florida
United States	SPRI Clinical Trials, LLC	Brooklyn	New York
United States	New Hope Clinical Research	Charlotte	North Carolina
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	Axiom Research, LLC	Colton	California
United States	FutureSearch Trials of Dallas, LP	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	iResearch Atlanta LLC	Decatur	Georgia
United States	InSite Clinical Research	DeSoto	Texas
United States	Pharmacology Research Institute	Encino	California
United States	Gulfcoast Clinical Research Center	Fort Myers	Florida
United States	University of California, San Francisco-Fresno	Fresno	California
United States	Collaborative Neuroscience Network, LLC.	Garden Grove	California
United States	Galiz Research	Hialeah	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Red Oak Psychiatry Associates, PA	Houston	Texas
United States	Clinical Neuroscience Solutions, Inc	Jacksonville	Florida
United States	Volunteer Research Group, an AMR Company	Knoxville	Tennessee
United States	Altea Research Institute	Las Vegas	Nevada
United States	Synergy San Diego	Lemon Grove	California
United States	Woodland International Research Group	Little Rock	Arkansas
United States	Pharmacology Research Institute	Los Alamitos	California
United States	CalNeuro Research Group	Los Angeles	California
United States	Northwest Behavioral Research Center	Marietta	Georgia
United States	Suburban Research Associates, Inc.	Media	Pennsylvania
United States	Clinical Neuroscience Solutions, Inc	Memphis	Tennessee
United States	BTC of New Bedford	New Bedford	Massachusetts
United States	Child Study Center at Yale University School of Medicine	New Haven	Connecticut
United States	Pharmacology Research Institute	Newport Beach	California
United States	Keystone Clinical Studies, LLC	Norristown	Pennsylvania
United States	Harmony Clinical Research	North Miami Beach	Florida
United States	Comprehensive Psychiatric Care	Norwich	Connecticut
United States	Pacific Research Partners, LLC	Oakland	California
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	NRC Research Institute	Orange	California
United States	Clinical Neuroscience Solutions, Inc	Orlando	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)	Portland	Oregon
United States	Summit Research Network (Oregon) Inc.	Portland	Oregon
United States	Phoenix Medical Research	Prairie Village	Kansas
United States	Desert Valley Research	Rancho Mirage	California
United States	Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)	Salem	Oregon
United States	Atemis Institute for Clinical Research	San Marcos	California
United States	California Neuroscience Research Medical Group, Inc	Sherman Oaks	California
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Stedman Clinical Trials	Tampa	Florida
United States	CNS Network	Torrance	California
United States	Pacific Clinical Research Medical Group	Upland	California
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	Grayline Clinical Drug Trials	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Biohaven Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	A serious adverse event (SAE) was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention.; Treatment-emergent AEs (TEAEs) in the randomization phase included any adverse event (AE) with an onset date on or after the first day of double-blind study drug and up to the first day of open-label study drug in the extension phase (for participants entering the extension phase) or last day of the randomization phase study drug + 30 days.	From first dose to Week 8 plus 30 days (maximum duration: 12 weeks)
Secondary	Number of Participants With Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs Judged to be Related to Study Drug During Extension Phase	An SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention.; TEAEs in the extension phase included any AE with an onset date on or after the first day of the study drug in the extension phase and up to the last day of the study drug in the extension phase + 30 days.	From Week 9 to the last dose of troriluzole in extension phase plus 30 days (maximum duration: 333 days)
Secondary	Number of Participants With Clinically Significant Laboratory Abnormalities During the Randomization Phase	Clinically significant laboratory abnormalities were defined as Grade 3 to 4 laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events (CTCAE) Version 5.0 (2017) or the Division of Acquired Immune Deficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017), where Grade 3=Severe and Grade 4=Potentially Life Threatening. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis.	From first dose to Week 8 plus 30 days (maximum duration: 12 weeks)
Secondary	Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8	The SDS was assessed in 3 domains: work/school (0-10), social life (0-10), and family life (0-10). The score from each domain was summed into a single-dimensional measure of global functional impairment (SDS total score) that ranged from 0 (unimpaired) to 30 (highly impaired).	Baseline, Week 8
Secondary	Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score at Week 8	Participants rated on the seven-point severity of Illness with severity of wherein 1 = normal, not at all; 2= borderline ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7 = among the most extremely ill participants.	Baseline, Week 8