Overview

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

Status:
Recruiting
Trial end date:
2025-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cerevel Therapeutics, LLC
Criteria
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 Mini
International Neuropsychiatric Interview (MINI) for Psychotic Disorders

- 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 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