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

• Sponsor: Cerevel Therapeutics, LLC (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05941442
• Collaborator: (none)
• Enrollment: 228
• Locations: 23
• Arms: 2
• Anticipated Duration (Months): 21
• Patients Per Site: 9.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Panic Disorder	Drug: Darigabat; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 228 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2025
• Anticipated Study Completion Date: Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Darigabat 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.	Drug: Darigabat; Oral tablets; Other Names: CVL-865
Placebo Comparator: Placebo 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.	Drug: Placebo; Oral tablets

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Free of Panic Attacks as Assessed by Participant Daily Diary During Maintenance Treatment Period [Week 14]

Secondary Outcome Measures

1. Change from Baseline in the Panic Disorder Severity Scale (PDSS) Total Score at Week 14 [Baseline and Week 14]

2. Change from Baseline in Panic Attack Frequency During the Last Two Weeks of the Maintenance Treatment Period [Baseline, Week 13, and Week 14]

3. 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]

4. Change from Baseline at all Time Points up to Week 14 in the PDSS Total Score and Subscores [Baseline through Week 14]

5. Change from Baseline at all Time Points up to Week 15 in Panic Attack Frequency [Baseline through Week 15]

6. 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]

7. Change from Baseline at all Time Points up to Week 14 in the Hamilton Anxiety Scale (HAM-A) Total Score [Baseline through Week 14]

8. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [From Day 1 through Week 18]

9. Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results [Up to Week 14]

10. Number of Participants with Clinically Significant Changes in Clinical Laboratory Assessment Values [Up to Week 18]

11. Number of Participants with Clinically Significant Changes in Vital Sign Measurements [Up to Week 14]

12. Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results [Up to Week 14]

13. Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) [Up to Week 14]

14. Number of Participants with Withdrawal Symptoms Assessed Using the Penn Physician's Withdrawal Checklist (PWC) [Up to Week 15]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix, Arizona	Phoenix	Arizona	United States	85012
2	Bryant, Arkansas	Bryant	Arkansas	United States	72022
3	Lafayette, California	Lafayette	California	United States	94549
4	Los Angeles, California	Los Angeles	California	United States	90025
5	Riverside, California	Riverside	California	United States	92506
6	Torrance, California	Torrance	California	United States	90502
7	Miami, Florida	Miami	Florida	United States	33175
8	Orlando, Florida	Orlando	Florida	United States	32807
9	Atlanta, Georgia	Atlanta	Georgia	United States	30331
10	Decatur, Georgia	Decatur	Georgia	United States	30030
11	Savannah, Georgia	Savannah	Georgia	United States	31405
12	Overland Park, Kansas	Overland Park	Kansas	United States	66210
13	Boston, Massachusetts	Boston	Massachusetts	United States	02131
14	Las Vegas, Nevada	Las Vegas	Nevada	United States	89102
15	Berlin, New Jersey	Berlin	New Jersey	United States	08009
16	Brooklyn, New York	Brooklyn	New York	United States	11229
17	Brooklyn, New York	Brooklyn	New York	United States	11235
18	Rochester, New York	Rochester	New York	United States	14618
19	Staten Island, New York	Staten Island	New York	United States	10314
20	West Chester, Pennsylvania	West Chester	Pennsylvania	United States	19380
21	Austin, Texas	Austin	Texas	United States	78737
22	Dallas, Texas	Dallas	Texas	United States	75231
23	Everett, Washington	Everett	Washington	United States	98201

Sponsors and Collaborators

• Cerevel Therapeutics, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cerevel Therapeutics, LLC
• ClinicalTrials.gov Identifier: NCT05941442
• Other Study ID Numbers: CVL-865-PA-2001
• First Posted: Jul 12, 2023
• Last Update Posted: Jul 12, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Panic Disorder

Study Results

No Results Posted as of Jul 12, 2023