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

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ClinicalTrials.gov Identifier: NCT05941442
Recruitment Status : Recruiting
First Posted : July 12, 2023
Last Update Posted : May 14, 2024
Sponsor:
Information provided by (Responsible Party):
Cerevel Therapeutics, LLC

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 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
Actual Study Start Date : July 31, 2023
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : April 2025
Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. Percentage of Participants Free of Panic Attacks as Assessed by Participant Daily Diary During Maintenance Treatment Period [ Time Frame: Week 14 ]

Secondary Outcome Measures :
  1. Change from Baseline in the Panic Disorder Severity Scale (PDSS) Total Score at Week 14 [ Time Frame: Baseline and Week 14 ]
  2. Change from Baseline in Panic Attack Frequency During the Last Two Weeks of the Maintenance Treatment Period [ Time Frame: 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 [ Time Frame: Baseline through Week 15 ]
  4. Change from Baseline at all Time Points up to Week 14 in the PDSS Total Score and Subscores [ Time Frame: Baseline through Week 14 ]
  5. Change from Baseline at all Time Points up to Week 15 in Panic Attack Frequency [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline through Week 14 ]
  8. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From Day 1 through Week 18 ]
  9. Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results [ Time Frame: Up to Week 14 ]
  10. Number of Participants with Clinically Significant Changes in Clinical Laboratory Assessment Values [ Time Frame: Up to Week 18 ]
  11. Number of Participants with Clinically Significant Changes in Vital Sign Measurements [ Time Frame: Up to Week 14 ]
  12. Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results [ Time Frame: Up to Week 14 ]
  13. Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to Week 14 ]
  14. Number of Participants with Withdrawal Symptoms Assessed Using the Penn Physician's Withdrawal Checklist (PWC) [ Time Frame: Up to Week 15 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05941442


Contacts
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Contact: Cerevel Clinical Trial Support cerevelclinicaltrials@cerevel.com

Locations
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Sponsors and Collaborators
Cerevel Therapeutics, LLC
More Information
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Responsible Party: Cerevel Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT05941442    
Other Study ID Numbers: CVL-865-PA-2001
First Posted: July 12, 2023    Key Record Dates
Last Update Posted: May 14, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Panic Disorder
Anxiety Disorders
Mental Disorders