A Study to Evaluate Efficacy, Safety, and Tolerability of Darigabat in Participants With Panic Di… (NCT05941442) | Clinical Trial Compass
TerminatedPhase 2
A Study to Evaluate Efficacy, Safety, and Tolerability of Darigabat in Participants With Panic Disorder
Stopped: Sponsor terminated due to significant enrollment and study design challenges
United States80 participantsStarted 2023-07-31
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 …
What they're measuring
1
Percentage of Participants Free of Panic Attacks as Assessed by Participant Daily eDiary During the Last Two Weeks of the Maintenance Treatment Period