The trial is taking place at:
T

TLC Research | Los Angeles, California

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

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Cerevel Therapeutics

Status and phase

Enrolling
Phase 2

Conditions

Panic Disorder

Treatments

Drug: Placebo
Drug: Darigabat

Study type

Interventional

Funder types

Industry

Identifiers

NCT05941442
CVL-865-PA-2001

Details and patient eligibility

About

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.

Enrollment

246 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

246 participants in 2 patient groups, including a placebo group

Darigabat
Experimental group
Description:
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.
Treatment:
Drug: Darigabat
Placebo
Placebo Comparator group
Description:
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.
Treatment:
Drug: Placebo

Trial contacts and locations

24

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Central trial contact

Cerevel Clinical Trial Support

Data sourced from clinicaltrials.gov

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