A Study to Evaluate Efficacy, Safety, and Tolerability of Darigabat in Participants With Panic Disorder
NCT ID: NCT05941442
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2023-07-31
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Darigabat
Oral tablets
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.
Placebo
Oral tablets
Interventions
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Darigabat
Oral tablets
Placebo
Oral tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Decatur, Georgia
Decatur, Georgia, United States
Savannah, Georgia
Savannah, Georgia, United States
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
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
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
Countries
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Other Identifiers
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CVL-865-PA-2001
Identifier Type: -
Identifier Source: org_study_id
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