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

Panic Disorder Clinical Trial

Official title:

A Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Darigabat in Participants With Panic Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05941442
• Other study ID #: CVL-865-PA-2001
• Status: Recruiting
• Phase: Phase 2
• Start date: July 31, 2023
• Est. completion date: April 2025

Study information

• Verified date: June 2024
• Source: Cerevel Therapeutics, LLC
• Contact: Cerevel Clinical Trial Support
• Email: cerevelclinicaltrials[@]cerevel.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 246
• Est. completion date: April 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Panic Disorder

Intervention

Drug:
• Darigabat
Oral tablets
• Placebo
Oral tablets

Locations

Country	Name	City	State
United States	Atlanta, Georgia	Atlanta	Georgia
United States	Austin, Texas	Austin	Texas
United States	Berlin, New Jersey	Berlin	New Jersey
United States	Boston, Massachusetts	Boston	Massachusetts
United States	Brooklyn, New York	Brooklyn	New York
United States	Brooklyn, New York	Brooklyn	New York
United States	Dallas, Texas	Dallas	Texas
United States	Decatur, Georgia	Decatur	Georgia
United States	Draper, Utah	Draper	Utah
United States	Everett, Washington	Everett	Washington
United States	Lafayette, California	Lafayette	California
United States	Las Vegas, Nevada	Las Vegas	Nevada
United States	Los Angeles, California	Los Angeles	California
United States	Miami, Florida	Miami	Florida
United States	Oceanside, California	Oceanside	California
United States	Orlando, Florida	Orlando	Florida
United States	Overland Park, Kansas	Overland Park	Kansas
United States	Phoenix, Arizona	Phoenix	Arizona
United States	Riverside, California	Riverside	California
United States	Rochester, New York	Rochester	New York
United States	Savannah, Georgia	Savannah	Georgia
United States	Staten Island, New York	Staten Island	New York
United States	Torrance, California	Torrance	California
United States	West Chester, Pennsylvania	West Chester	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Cerevel Therapeutics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Free of Panic Attacks as Assessed by Participant Daily Diary During Maintenance Treatment Period		Week 14
Secondary	Change from Baseline in the Panic Disorder Severity Scale (PDSS) Total Score at Week 14		Baseline and Week 14
Secondary	Change from Baseline in Panic Attack Frequency During the Last Two Weeks of the Maintenance Treatment Period		Baseline, Week 13, and Week 14
Secondary	Change from Baseline at all Time Points up to Week 15 in the Proportion of Participants Free of Panic Attacks as Assessed by Participant Daily Diary		Baseline through Week 15
Secondary	Change from Baseline at all Time Points up to Week 14 in the PDSS Total Score and Subscores		Baseline through Week 14
Secondary	Change from Baseline at all Time Points up to Week 15 in Panic Attack Frequency		Baseline through Week 15
Secondary	Change from Baseline at all Time Points up to Week 14 in the Clinical Global Impression-Severity of Symptoms Scale (CGI-S) Score		Baseline through Week 14
Secondary	Change from Baseline at all Time Points up to Week 14 in the Hamilton Anxiety Scale (HAM-A) Total Score		Baseline through Week 14
Secondary	Number of Participants with Treatment-emergent Adverse Events (TEAEs)		From Day 1 through Week 18
Secondary	Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results		Up to Week 14
Secondary	Number of Participants with Clinically Significant Changes in Clinical Laboratory Assessment Values		Up to Week 18
Secondary	Number of Participants with Clinically Significant Changes in Vital Sign Measurements		Up to Week 14
Secondary	Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results		Up to Week 14
Secondary	Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)		Up to Week 14
Secondary	Number of Participants with Withdrawal Symptoms Assessed Using the Penn Physician's Withdrawal Checklist (PWC)		Up to Week 15