A Study to Evaluate Efficacy, Safety, and Tolerability of Darigabat in Participants With Panic Disorder

Last updated: April 2, 2025
Sponsor: AbbVie
Overall Status: Completed

Phase

2

Condition

Anxiety Disorders

Mood Disorders

Treatment

Darigabat

Placebo

Clinical Study ID

NCT05941442
CVL-865-PA-2001
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this trial is to measure the efficacy, safety, and tolerability of darigabat (25 milligrams [mg] twice daily [BID]) compared with placebo in participants with panic disorder.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Primary diagnosis of panic disorder based on Diagnostic and Statistical Manual ofMental Disorders, Fifth Edition Text Revision (DSM-5-TR), as confirmed by theStandard Mini International Neuropsychiatric Interview (MINI)

  • Participant has had a minimum of 8 panic attacks, with no week free of panicattacks, in the month prior to the Screening Visit. In the 2 weeks prior to theBaseline Visit, the participant must have had at least 4 panic attacks and no weekfree of panic attacks

  • Participants with a PDSS total score ≥12 at the Screening and Baseline Visits

  • Body mass index of 17.5 to 40.0 kilograms per meter square (kg/m2) and a total bodyweight >48 kg at Screening

Exclusion

Exclusion Criteria:

  • Participants who have a current significant psychiatric comorbidity

  • Any newly initiated evidence-based psychotherapy, including cognitive behavioraltherapy (CBT)

  • Any exposure-based therapy is prohibited throughout the duration of the trial

  • Participants with a current history of significant cardiovascular, pulmonary,gastrointestinal, renal, hepatic, metabolic, hematological, immunological, orneurological disease

  • Participants who answer "Yes" on the following C-SSRS Suicidal Ideation Items (within the last 6 months)

  • Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act,Without Specific Plan) OR

  • Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan andIntent) OR Participants who answer "Yes" on any of the 5 C-SSRS SuicidalBehavior Items (within the last 2 years)

  • Any of the Suicidal Behavior items (actual attempt, interrupted attempt,aborted attempt, preparatory acts, or behavior) OR

  • Participants who, in the opinion of the investigator, present a serious risk ofsuicide

NOTE: Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Darigabat
Phase: 2
Study Start date:
July 31, 2023
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Phoenix, Arizona

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Bryant, Arkansas

    Bryant, Arkansas 72022
    United States

    Site Not Available

  • Lafayette, California

    Lafayette, California 94549
    United States

    Site Not Available

  • Los Angeles, California

    Los Angeles, California 90025
    United States

    Site Not Available

  • Oceanside, California

    Oceanside, California 92056
    United States

    Site Not Available

  • Orange, California

    Orange, California 92868
    United States

    Site Not Available

  • Riverside, California

    Riverside, California 92506
    United States

    Site Not Available

  • San Jose, California

    San Jose, California 95124
    United States

    Site Not Available

  • Torrance, California

    Torrance, California 90502
    United States

    Site Not Available

  • Miami, Florida

    Miami, Florida 33175
    United States

    Site Not Available

  • North Miami Beach, Florida

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Orlando, Florida

    Orlando, Florida 32807
    United States

    Site Not Available

  • Atlanta, Georgia

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • Decatur, Georgia

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Savannah, Georgia

    Savannah, Georgia 31405
    United States

    Site Not Available

  • Elgin, Illinois

    Elgin, Illinois 60123
    United States

    Site Not Available

  • Overland Park, Kansas

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Boston, Massachusetts

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • Las Vegas, Nevada

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Berlin, New Jersey

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Brooklyn, New York

    Brooklyn, New York 11229
    United States

    Site Not Available

  • New York, New York

    New York, New York 10016
    United States

    Site Not Available

  • Rochester, New York

    Rochester, New York 14618
    United States

    Site Not Available

  • Staten Island, New York

    Staten Island, New York 10314
    United States

    Site Not Available

  • Monroe, North Carolina

    Monroe, North Carolina 28112
    United States

    Site Not Available

  • Oklahoma City, Oklahoma

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • West Chester, Pennsylvania

    West Chester, Pennsylvania 19380
    United States

    Site Not Available

  • Austin, Texas

    Austin, Texas 78737
    United States

    Site Not Available

  • Dallas, Texas

    Dallas, Texas 75231
    United States

    Site Not Available

  • Desoto, Texas

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Draper, Utah

    Draper, Utah 84020
    United States

    Site Not Available

  • Everett, Washington

    Everett, Washington 98201
    United States

    Site Not Available

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