A Phase 2, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 2 mg and 4 mg SUVN-G3031 Compared to Placebo in Patients With Narcolepsy With and Without Cataplexy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 39
- 主要终点
- Epworth Sleepiness Scale
研究概览
简要总结
This study is of an investigational drug called SUVN-G3031 (Samelisant) as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy. The main purpose of this study is to learn how well the study drug works and how safe the study drug is compared to placebo.
详细描述
This is a Phase 2, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SUVN-G3031 compared to placebo in participants with narcolepsy with and without cataplexy. Participants will be randomized at a ratio of 1:1:1 to 2 mg SUVN-G3031, 4 mg SUVN-G3031, or placebo. Each participant will receive study drug once daily, in a tablet formulation, for 14 days.
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
- Double (Participant, Investigator)
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
- •Ages of 18 to 65 years (adult), inclusive.
- •Have narcolepsy with or without cataplexy (Na-1 or Na-2) based on the International Classification of Sleep Disorders (3rd edition) criteria (new or previously diagnosed).
- •Have undergone a multiple sleep latency test (MSLT) study showing an MSLT of ≤ 8 minutes.
- •An Epworth Sleepiness Scale (ESS) score of ≥ 12; and mean Maintenance of Wakefulness Test (MWT) time of < 12 min.
- •Body mass index ranging from 18 to < 45 kg/m2
- •Negative urine drug screen.
- •A woman must be either not of childbearing potential or of childbearing potential practicing highly effective methods of birth control.
- •Willingness to complete the study protocol with full compliance with procedures and sign an informed consent form (ICF).
排除标准
- •Habitual wake-up time after 8 AM as assessed by sleep diary, habitual sleep time of < 6 hours, and habitual bedtime past 1 AM as determined by sleep diary entries.
- •Use of any investigational therapy within the 30-day period prior to enrollment.
- •Excessive caffeine (defined as > 600 mg/per day) use at least 1 week prior to baseline assessments and during the course of the trial.
- •Nicotine dependence that has an effect on sleep (eg, a patient who routinely awakens at night to smoke).
- •Use of concurrent medications prescribed to treat narcolepsy as specified including stimulants, antidepressants and sodium oxybate.
- •Current diagnosis of or past treatment for syndromes known to cause sleep disruption or any other cause of daytime sleepiness.
- •Clinically significant ECG abnormalities.
- •An occupation requiring variable shift work, night shifts, or frequent overnight travel which disrupts sleep patterns.
研究组 & 干预措施
SUVN-G3031 2mg
Orally taken once daily for 14 days
干预措施: SUVN-G3031 (Drug)
SUVN-G3031 4mg
Orally taken once daily for 14 days
干预措施: SUVN-G3031 (Drug)
Placebo
Orally taken once daily for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Epworth Sleepiness Scale
时间窗: Change from baseline in the mean total ESS score at Day 14
The Epworth Sleepiness Scale (ESS) is a patient-reported questionnaire consisting of 8 questions. Each of the items are rated on a 4-point scale (0-3), based on the usual chances of dozing off or falling asleep while engaged in eight different activities. The total ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. Higher values represent a worse outcome.
次要结局
- Clinical Global Impression of Severity(Change from baseline in the mean CGI-S score at Day 14)
- Maintenance of Wakefulness Test(Change from baseline in the mean MWT score at Day 14)