NCT05941442终止2 期
A Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Darigabat in Participants With Panic Disorder
AbbVie61 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年7月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 61
- 主要终点
- Percentage of Participants Free of Panic Attacks as Assessed by Participant Daily Diary During Maintenance Treatment Period
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo Comparator
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.
干预措施: Placebo (Drug)
Darigabat
Experimental
Participants will receive darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
干预措施: Darigabat (Drug)
结局指标
主要结局
Percentage of Participants Free of Panic Attacks as Assessed by Participant Daily Diary During Maintenance Treatment Period
时间窗: Week 14
次要结局
- Change from Baseline in the Panic Disorder Severity Scale (PDSS) Total Score at Week 14(Baseline and Week 14)
- Change from Baseline in Panic Attack Frequency During the Last Two Weeks of the Maintenance Treatment Period(Baseline, Week 13, and Week 14)
- 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)
- Change from Baseline at all Time Points up to Week 15 in Panic Attack Frequency(Baseline through Week 15)
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)(From Day 1 through Week 18)
- Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results(Up to Week 14)
- Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)(Up to Week 14)
- Number of Participants with Withdrawal Symptoms Assessed Using the Penn Physician's Withdrawal Checklist (PWC)(Up to Week 15)
- Change from Baseline at all Time Points up to Week 14 in the PDSS Total Score and Subscores(Baseline through Week 14)
- 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)
- Change from Baseline at all Time Points up to Week 14 in the Hamilton Anxiety Scale (HAM-A) Total Score(Baseline through Week 14)
- Number of Participants with Clinically Significant Changes in Clinical Laboratory Assessment Values(Up to Week 18)
- Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results(Up to Week 14)
- Number of Participants with Clinically Significant Changes in Vital Sign Measurements(Up to Week 14)
研究者
研究点 (61)
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