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

NCT05941442 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: CVL-865-PA-2001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 31

Brief 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.

Conditions

Panic Disorder

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Free of Panic Attacks as Assessed by Participant Daily eDiary During the Last Two Weeks of the Maintenance Treatment Period

  Numerator is the number of participants in the period who were panic free and had no fewer that 12 eDiary entries. Denominator is the number of participants in the period who were panic free and had no fewer than 12 eDiary entries in the corresponding time period plus anyone who had an eDiary entry and reported a panic attack in the corresponding time period, regardless of number of eDiary entries.

  Week 13-14

Secondary Outcomes (14)

• Change From Baseline in the Panic Disorder Severity Scale (PDSS) Total Score at Week 14

  Week 14 (Day 98)

• Change From Baseline in Panic Attack Frequency During the Last Two Weeks of the Maintenance Treatment Period

  Week 13-14

• Change From Baseline in the Proportion of Participants Free of Panic Attacks as Assessed by Participant Daily Diary by Two-Week Intervals

  Baseline through Week 14 (2 Weeks Titration and 12 Weeks Maintenance Treatment)

• Change From Baseline at All Time Points up to Week 14 in the PDSS Total Score

  Baseline through Week 14

• Change From Baseline in Panic Attack Frequency by Two-Week Intervals Through Week 14

  Baseline through Week 14 (2 Weeks Titration and 12 Weeks Maintenance Treatment)

Study Arms (2)

Darigabat

EXPERIMENTAL

Participants will receive darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.

Drug: Darigabat

Placebo

PLACEBO COMPARATOR

Participants will receive darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.

Drug: Placebo

Interventions

Placebo DRUG

Oral tablets

Placebo

Darigabat DRUG

Oral tablets

Also known as: CVL-865

Darigabat

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary diagnosis of panic disorder based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR), as confirmed by the Standard Mini International Neuropsychiatric Interview (MINI)
• Participant has had a minimum of 8 panic attacks, with no week free of panic attacks, in the month prior to the Screening Visit. In the 2 weeks prior to the Baseline Visit, the participant must have had at least 4 panic attacks and no week free 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 body weight \>48 kg at Screening

You may not qualify if:

• Participants who have a current significant psychiatric comorbidity
• Any newly initiated evidence-based psychotherapy, including cognitive behavioral therapy (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, or neurological 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 and Intent) OR Participants who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior 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 of suicide

Sponsors & Collaborators

• AbbVie: lead

Study Sites (31)

Phoenix, Arizona

Phoenix, Arizona, 85012, United States

Location

Lafayette, California

Lafayette, California, 94549, United States

Location

Los Angeles, California

Los Angeles, California, 90025, United States

Location

Oceanside, California

Oceanside, California, 92056, United States

Location

Orange, California

Orange, California, 92868, United States

Location

Riverside, California

Riverside, California, 92506, United States

Location

San Jose, California

San Jose, California, 95124, United States

Location

Torrance, California

Torrance, California, 90502, United States

Location

Miami, Florida

Miami, Florida, 33175, United States

Location

North Miami Beach, Florida

North Miami Beach, Florida, 33162, United States

Location

Orlando, Florida

Orlando, Florida, 32807, United States

Location

Atlanta, Georgia

Atlanta, Georgia, 30331, United States

Location

Decatur, Georgia

Decatur, Georgia, 30030, United States

Location

Savannah, Georgia

Savannah, Georgia, 31405, United States

Location

Elgin, Illinois

Elgin, Illinois, 60123, United States

Location

Overland Park, Kansas

Overland Park, Kansas, 66210, United States

Location

Boston, Massachusetts

Boston, Massachusetts, 02131, United States

Location

Las Vegas, Nevada

Las Vegas, Nevada, 89102, United States

Location

Berlin, New Jersey

Berlin, New Jersey, 08009, United States

Location

Brooklyn, New York

Brooklyn, New York, 11229, United States

Location

Brooklyn, New York

Brooklyn, New York, 11235, United States

Location

New York, New York

New York, New York, 10016, United States

Location

Rochester, New York

Rochester, New York, 14618, United States

Location

Staten Island, New York

Staten Island, New York, 10314, United States

Location

Monroe, North Carolina

Monroe, North Carolina, 28112, United States

Location

Oklahoma City, Oklahoma

Oklahoma City, Oklahoma, 73112, United States

Location

West Chester, Pennsylvania

West Chester, Pennsylvania, 19380, United States

Location

Austin, Texas

Austin, Texas, 78737, United States

Location

Desoto, Texas

DeSoto, Texas, 75115, United States

Location

Draper, Utah

Draper, Utah, 84020, United States

Location

Everett, Washington

Everett, Washington, 98201, United States

Location

MeSH Terms

Conditions

Panic Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 12, 2023
• Study Start: July 31, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 7, 2026
• Results First Posted: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (31)