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

Phase 2TerminatedNCT05941442

AbbVie80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Panic Disorder

Interventions

DarigabatDRUG

Oral tablets

PlaceboDRUG

Oral tablets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (31)

Outcomes

Primary Outcomes

Percentage of Participants Free of Panic Attacks as Assessed by Participant Daily eDiary During the Last Two Weeks of the Maintenance Treatment Period

Numerator is the number of participants in the period who were panic free and had no fewer that 12 eDiary entries. Denominator is the number of participants in the period who were panic free and had no fewer than 12 eDiary entries in the corresponding time period plus anyone who had an eDiary entry and reported a panic attack in the corresponding time period, regardless of number of eDiary entries.

Time frame: Week 13-14

Secondary Outcomes

Change From Baseline in the Panic Disorder Severity Scale (PDSS) Total Score at Week 14

The Panic Disorder Severity Scale (PDSS) is a 7-item scale, with each item rated on a 5-point scale (0-4), allowing a total of 0-28 where higher score reflects greater disease severity.

Time frame: Week 14 (Day 98)

Change From Baseline in Panic Attack Frequency During the Last Two Weeks of the Maintenance Treatment Period

Time frame: Week 13-14

Change From Baseline in the Proportion of Participants Free of Panic Attacks as Assessed by Participant Daily Diary by Two-Week Intervals

Numerator is the number of participants who were panic free and had no fewer than 12 eDiary entries in the corresponding time period. Denominator is the number of participants in the period who were panic free and had no fewer than 12 eDiary entries in the corresponding time period plus anyone who had an eDiary entry and reported a panic attack in the corresponding time period, regardless of number of eDiary entries. \* Last Two Weeks of Maintenance Treatment Prior to Subject's Completion/Early Termination = Includes assessments made in the last two weeks of the Maintenance Period prior to completion/early termination for all subjects that had at least 2 weeks of data in the maintenance period, which would be Maintenance Week 11-12 for subjects who completed and earlier for subjects who terminated study participation prior to completion.

Data from ClinicalTrials.gov

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Phoenix, Arizona

Phoenix, Arizona, United States

Lafayette, California

Lafayette, California, United States

Los Angeles, California

Los Angeles, California, United States

Oceanside, California

Oceanside, California, United States

Orange, California

Orange, California, United States

Riverside, California

Riverside, California, United States

San Jose, California

San Jose, California, United States

Torrance, California

Torrance, California, United States

Miami, Florida

Miami, Florida, United States

North Miami Beach, Florida

North Miami Beach, Florida, United States

...and 21 more locations

Time frame: Baseline through Week 14 (2 Weeks Titration and 12 Weeks Maintenance Treatment)

Change From Baseline at All Time Points up to Week 14 in the PDSS Total Score

The Panic Disorder Severity Scale (PDSS) is a 7-item scale, with each item rated on a 5-point scale (0-4), allowing a total of 0-28 where higher score reflects greater disease severity. Change from baseline = value - baseline value; n = number of participants with a non-missing value; overall N = number of participants in treatment group

Time frame: Baseline through Week 14

Change From Baseline in Panic Attack Frequency by Two-Week Intervals Through Week 14

Panic attack frequency is defined as the total number of panic attacks over each two-week interval divided by the total number of days the eDiary was completed in the same analysis period multiplied by 14. Participants with a minimum of 7 completed diary days in a two-week interval will be considered for panic attack frequency, otherwise will be considered missing. Change from baseline = value - baseline value; n = number of participants with a non-missing value; overall N = number of participants in treatment group \* Last Two Weeks of Maintenance Treatment Prior to Subject's Completion/Early Termination = Includes assessments made in the last two weeks of the Maintenance Period prior to completion/early termination for all subjects that had at least 2 weeks of data in the maintenance period, which would be Maintenance Week 11-12 for subjects who completed and earlier for subjects who terminated study participation prior to completion.

Time frame: Baseline through Week 14 (2 Weeks Titration and 12 Weeks Maintenance Treatment)

Change From Baseline at All Time Points up to Week 14 in the Clinical Global Impression-Severity of Symptoms Scale (CGI-S) Score

The Clinical Global Impression-Severity (CGI-S) scale is a single item 7-point scale, with panic order severity rated from 1 (normal) through to 7 (most severely ill). Change from baseline = value - baseline value; n = number of participants with a non-missing value; overall N = number of participants in treatment group.

Time frame: Baseline through Week 14

Change From Baseline at All Time Points up to Week 14 in the Hamilton Anxiety Scale (HAM-A) Total Score

The Hamilton Anxiety Scale (HAM-A) is a 14-item scale measures severity of anxiety symptoms. Each item is scored on a scale from 0 (not present) to 4 (severe) resulting in a total score range of 0 to 56, with higher scores indicating more severe anxiety. Change from baseline = value - baseline value; n = number of participants with a non-missing value; overall N = number of participants in treatment group.

Time frame: Baseline through Week 14

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

A Treatment-Emergent Adverse Event (TEAE) is any event reported on the CRF that occurs on or after the initiation of IMP and through follow-up contact.

Time frame: From Day 1 through Week 18

Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Results

12-lead ECGs recordings were obtained after the participant had been supine and at rest for at least 3 minutes. The number of participants with significant abnormalities is reported by 'change from baseline in QT interval as corrected for heart rate by Fridericia's formula (QTcF)'.

Time frame: Up to Week 14

Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessment Values

Protocol-required safety laboratory tests were performed, including hematology, chemistry and urinalysis tests. Reported here is the number of participants with clinically significant changes in these laboratory tests.

Time frame: Up to Week 18

Number of Participants With Clinically Significant Changes in Vital Sign Measurements

Vital signs were measured with the participant in a sitting/semi-recumbent position after 3 minutes rest and included temperature, systolic and diastolic blood pressure, respiratory rate, and heart rate. Reported here is the number of participants with clinically significant changes in vital sign measurements.

Time frame: Up to Week 14

Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results

A complete physical examination consisted of measurement of weight and a review of the following body systems: head, ears, eyes, nose, mouth, skin, heart, lungs, lymph nodes, and gastrointestinal, genitourinary, and musculoskeletal systems. A full neurological examination included an assessment of the participant's mental status (level of consciousness, orientation, speech, memory, etc), cranial nerves, motor (muscle appearance, tone, strength, and reflexes), sensation (including Romberg sign), coordination, and gait. Reported here is the number of participants with clinically significant changes in physical or neurological examination results.

Time frame: Up to Week 14

Number of Participants With Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)

The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent). Reported here is the number of participants with changes in suicidality assessed using the C-SSRS scale.

Time frame: Up to Week 14

Number of Participants With Withdrawal Symptoms Assessed Using the Penn Physician's Withdrawal Checklist (PWC)

The PWC is a 20-item scale to measure discontinuation symptoms after stopping a medication for anxiety disorders. All 20 items are rated on a 4-point numeric-rating scale ranging from 0 (not present), 1 (mild), 2 (moderate), to 3 (severe). A total score, ranging 0 to 60, was calculated in addition to the individual scores for each item. Lower scores indicate less severity in discontinuation symptoms. Reported here is the number of participants with withdrawal symptoms assessed using the PWC.

Time frame: Up to Week 15