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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Panic Disorder

In brief

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.

Key facts

Study ID

NCT05941442

Run by

AbbVie

People needed

80

Starts

2023-07-31

Expected to finish

2025-03-31

Last updated by the study team

2026-05-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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