Clinical trial NCT05941442: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Panic Disorder
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-07-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 Standard Mini International Neuropsychiatric Interview (MINI)
* 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

Primary outcomes:
measure: Percentage of Participants Free of Panic Attacks as Assessed by Participant Daily Diary During Maintenance Treatment Period
timeFrame: Week 14
Secondary outcomes:
measure: Change from Baseline in the Panic Disorder Severity Scale (PDSS) Total Score at Week 14
timeFrame: Baseline and Week 14
measure: Change from Baseline in Panic Attack Frequency During the Last Two Weeks of the Maintenance Treatment Period
timeFrame: Baseline, Week 13, and Week 14
measure: 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
timeFrame: Baseline through Week 15
measure: Change from Baseline at all Time Points up to Week 14 in the PDSS Total Score and Subscores
timeFrame: Baseline through Week 14
measure: Change from Baseline at all Time Points up to Week 15 in Panic Attack Frequency
timeFrame: Baseline through Week 15
measure: Change from Baseline at all Time Points up to Week 14 in the Clinical Global Impression-Severity of Symptoms Scale (CGI-S) Score
timeFrame: Baseline through Week 14
measure: Change from Baseline at all Time Points up to Week 14 in the Hamilton Anxiety Scale (HAM-A) Total Score
timeFrame: Baseline through Week 14
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: From Day 1 through Week 18
measure: Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results
timeFrame: Up to Week 14
measure: Number of Participants with Clinically Significant Changes in Clinical Laboratory Assessment Values
timeFrame: Up to Week 18
measure: Number of Participants with Clinically Significant Changes in Vital Sign Measurements
timeFrame: Up to Week 14
measure: Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results
timeFrame: Up to Week 14
measure: Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to Week 14
measure: Number of Participants with Withdrawal Symptoms Assessed Using the Penn Physician's Withdrawal Checklist (PWC)
timeFrame: Up to Week 15
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix, Arizona
state: Arizona
city: Lafayette
country: United States
facility: Lafayette, California
state: California
city: Los Angeles
country: United States
facility: Los Angeles, California
state: California
city: Oceanside
country: United States
facility: Oceanside, California
state: California
city: Orange
country: United States
facility: Orange, California
state: California
city: Riverside
country: United States
facility: Riverside, California
state: California
city: San Jose
country: United States
facility: San Jose, California
state: California
city: Torrance
country: United States
facility: Torrance, California
state: California
city: Miami
country: United States
facility: Miami, Florida
state: Florida
city: North Miami Beach
country: United States
facility: North Miami Beach, Florida
state: Florida
city: Orlando
country: United States
facility: Orlando, Florida
state: Florida
city: Atlanta
country: United States
facility: Atlanta, Georgia
state: Georgia
city: Decatur
country: United States
facility: Decatur, Georgia
state: Georgia
city: Savannah
country: United States
facility: Savannah, Georgia
state: Georgia
city: Elgin
country: United States
facility: Elgin, Illinois
state: Illinois
city: Overland Park
country: United States
facility: Overland Park, Kansas
state: Kansas
city: Boston
country: United States
facility: Boston, Massachusetts
state: Massachusetts
city: Las Vegas
country: United States
facility: Las Vegas, Nevada
state: Nevada
city: Berlin
country: United States
facility: Berlin, New Jersey
state: New Jersey
city: Brooklyn
country: United States
facility: Brooklyn, New York
state: New York
city: Brooklyn
country: United States
facility: Brooklyn, New York
state: New York
city: New York
country: United States
facility: New York, New York
state: New York
city: Rochester
country: United States
facility: Rochester, New York
state: New York
city: Staten Island
country: United States
facility: Staten Island, New York
state: New York
city: Monroe
country: United States
facility: Monroe, North Carolina
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma City, Oklahoma
state: Oklahoma
city: West Chester
country: United States
facility: West Chester, Pennsylvania
state: Pennsylvania
city: Austin
country: United States
facility: Austin, Texas
state: Texas
city: DeSoto
country: United States
facility: Desoto, Texas
state: Texas
city: Draper
country: United States
facility: Draper, Utah
state: Utah
city: Everett
country: United States
facility: Everett, Washington
state: Washington
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: