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

Primary Purpose

Panic Disorder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Darigabat
Placebo
Sponsored by
Cerevel Therapeutics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Phoenix, ArizonaRecruiting
  • Lafayette, CaliforniaRecruiting
  • Los Angeles, California
  • Riverside, CaliforniaRecruiting
  • Torrance, CaliforniaRecruiting
  • Miami, FloridaRecruiting
  • Orlando, FloridaRecruiting
  • Atlanta, GeorgiaRecruiting
  • Decatur, GeorgiaRecruiting
  • Savannah, GeorgiaRecruiting
  • Overland Park, KansasRecruiting
  • Boston, MassachusettsRecruiting
  • Las Vegas, NevadaRecruiting
  • Berlin, New JerseyRecruiting
  • Brooklyn, New YorkRecruiting
  • Brooklyn, New YorkRecruiting
  • Rochester, New YorkRecruiting
  • Staten Island, New YorkRecruiting
  • West Chester, PennsylvaniaRecruiting
  • Austin, TexasRecruiting
  • Dallas, TexasRecruiting
  • Draper, UtahRecruiting
  • Everett, WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Darigabat

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants Free of Panic Attacks as Assessed by Participant Daily Diary During Maintenance Treatment Period

Secondary Outcome Measures

Change from Baseline in the Panic Disorder Severity Scale (PDSS) Total Score at Week 14
Change from Baseline in Panic Attack Frequency During the Last Two Weeks of the Maintenance Treatment Period
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
Change from Baseline at all Time Points up to Week 14 in the PDSS Total Score and Subscores
Change from Baseline at all Time Points up to Week 15 in Panic Attack Frequency
Change from Baseline at all Time Points up to Week 14 in the Clinical Global Impression-Severity of Symptoms Scale (CGI-S) Score
Change from Baseline at all Time Points up to Week 14 in the Hamilton Anxiety Scale (HAM-A) Total Score
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results
Number of Participants with Clinically Significant Changes in Clinical Laboratory Assessment Values
Number of Participants with Clinically Significant Changes in Vital Sign Measurements
Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results
Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Number of Participants with Withdrawal Symptoms Assessed Using the Penn Physician's Withdrawal Checklist (PWC)

Full Information

First Posted
June 15, 2023
Last Updated
October 16, 2023
Sponsor
Cerevel Therapeutics, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05941442
Brief Title
A Study to Evaluate Efficacy, Safety, and Tolerability of Darigabat in Participants With Panic Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerevel Therapeutics, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Darigabat
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Darigabat
Other Intervention Name(s)
CVL-865
Intervention Description
Oral tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
Percentage of Participants Free of Panic Attacks as Assessed by Participant Daily Diary During Maintenance Treatment Period
Time Frame
Week 14
Secondary Outcome Measure Information:
Title
Change from Baseline in the Panic Disorder Severity Scale (PDSS) Total Score at Week 14
Time Frame
Baseline and Week 14
Title
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
Title
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
Title
Change from Baseline at all Time Points up to Week 14 in the PDSS Total Score and Subscores
Time Frame
Baseline through Week 14
Title
Change from Baseline at all Time Points up to Week 15 in Panic Attack Frequency
Time Frame
Baseline through Week 15
Title
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
Title
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
Title
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame
From Day 1 through Week 18
Title
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results
Time Frame
Up to Week 14
Title
Number of Participants with Clinically Significant Changes in Clinical Laboratory Assessment Values
Time Frame
Up to Week 18
Title
Number of Participants with Clinically Significant Changes in Vital Sign Measurements
Time Frame
Up to Week 14
Title
Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results
Time Frame
Up to Week 14
Title
Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame
Up to Week 14
Title
Number of Participants with Withdrawal Symptoms Assessed Using the Penn Physician's Withdrawal Checklist (PWC)
Time Frame
Up to Week 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cerevel Clinical Trial Support
Email
cerevelclinicaltrials@cerevel.com
Facility Information:
Facility Name
Phoenix, Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Individual Site Status
Recruiting
Facility Name
Lafayette, California
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Individual Site Status
Recruiting
Facility Name
Los Angeles, California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Riverside, California
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Individual Site Status
Recruiting
Facility Name
Torrance, California
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Name
Miami, Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Name
Orlando, Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanta, Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Recruiting
Facility Name
Decatur, Georgia
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Name
Savannah, Georgia
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Individual Site Status
Recruiting
Facility Name
Overland Park, Kansas
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston, Massachusetts
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Individual Site Status
Recruiting
Facility Name
Las Vegas, Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Recruiting
Facility Name
Berlin, New Jersey
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Individual Site Status
Recruiting
Facility Name
Brooklyn, New York
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Individual Site Status
Recruiting
Facility Name
Brooklyn, New York
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Individual Site Status
Recruiting
Facility Name
Rochester, New York
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Individual Site Status
Recruiting
Facility Name
Staten Island, New York
City
Staten Island
State/Province
New York
ZIP/Postal Code
10314
Country
United States
Individual Site Status
Recruiting
Facility Name
West Chester, Pennsylvania
City
West Chester
State/Province
Pennsylvania
ZIP/Postal Code
19380
Country
United States
Individual Site Status
Recruiting
Facility Name
Austin, Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Individual Site Status
Recruiting
Facility Name
Dallas, Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Draper, Utah
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Individual Site Status
Recruiting
Facility Name
Everett, Washington
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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