A Study to Evaluate Efficacy, Safety, and Tolerability of Darigabat in Participants With Panic Disorder
- Registration Number
- NCT05941442
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
-
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
NOTE: Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 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. Darigabat Darigabat Participants will receive darigabat, up to a maximum dose of 12.5 mg, orally, BID, for two weeks in the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks in the Maintenance Treatment Period.
- Primary Outcome Measures
Name Time Method Percentage of Participants Free of Panic Attacks as Assessed by Participant Daily Diary During Maintenance Treatment Period Week 14
- Secondary Outcome Measures
Name Time Method Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results Up to Week 14 Change from Baseline in the Panic Disorder Severity Scale (PDSS) Total Score at Week 14 Baseline and Week 14 Change from Baseline in Panic Attack Frequency During the Last Two Weeks of the Maintenance Treatment Period Baseline, Week 13, and Week 14 Change from Baseline at all Time Points up to Week 15 in the Proportion of Participants Free of Panic Attacks as Assessed by Participant Daily Diary Baseline through Week 15 Change from Baseline at all Time Points up to Week 15 in Panic Attack Frequency Baseline through Week 15 Number of Participants with Treatment-emergent Adverse Events (TEAEs) From Day 1 through Week 18 Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) Up to Week 14 Number of Participants with Withdrawal Symptoms Assessed Using the Penn Physician's Withdrawal Checklist (PWC) Up to Week 15 Change from Baseline at all Time Points up to Week 14 in the PDSS Total Score and Subscores Baseline through Week 14 Change from Baseline at all Time Points up to Week 14 in the Clinical Global Impression-Severity of Symptoms Scale (CGI-S) Score Baseline through Week 14 Change from Baseline at all Time Points up to Week 14 in the Hamilton Anxiety Scale (HAM-A) Total Score Baseline through Week 14 Number of Participants with Clinically Significant Changes in Clinical Laboratory Assessment Values Up to Week 18 Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results Up to Week 14 Number of Participants with Clinically Significant Changes in Vital Sign Measurements Up to Week 14
Trial Locations
- Locations (30)
Elgin, Illinois
🇺🇸Elgin, Illinois, United States
Overland Park, Kansas
🇺🇸Overland Park, Kansas, United States
Boston, Massachusetts
🇺🇸Boston, Massachusetts, United States
Las Vegas, Nevada
🇺🇸Las Vegas, Nevada, United States
Berlin, New Jersey
🇺🇸Berlin, New Jersey, United States
Brooklyn, New York
🇺🇸Brooklyn, New York, United States
New York, New York
🇺🇸New York, New York, United States
Rochester, New York
🇺🇸Rochester, New York, United States
Savannah, Georgia
🇺🇸Savannah, Georgia, United States
Decatur, Georgia
🇺🇸Decatur, Georgia, United States
Phoenix, Arizona
🇺🇸Phoenix, Arizona, United States
Lafayette, California
🇺🇸Lafayette, California, United States
Los Angeles, California
🇺🇸Los Angeles, California, United States
Oceanside, California
🇺🇸Oceanside, California, United States
Orange, California
🇺🇸Orange, California, United States
Riverside, California
🇺🇸Riverside, California, United States
San Jose, California
🇺🇸San Jose, California, United States
Torrance, California
🇺🇸Torrance, California, United States
Miami, Florida
🇺🇸Miami, Florida, United States
North Miami Beach, Florida
🇺🇸North Miami Beach, Florida, United States
Orlando, Florida
🇺🇸Orlando, Florida, United States
Atlanta, Georgia
🇺🇸Atlanta, Georgia, United States
Staten Island, New York
🇺🇸Staten Island, New York, United States
Monroe, North Carolina
🇺🇸Monroe, North Carolina, United States
Oklahoma City, Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
West Chester, Pennsylvania
🇺🇸West Chester, Pennsylvania, United States
Austin, Texas
🇺🇸Austin, Texas, United States
Desoto, Texas
🇺🇸DeSoto, Texas, United States
Draper, Utah
🇺🇸Draper, Utah, United States
Everett, Washington
🇺🇸Everett, Washington, United States