NCT07675135招募中3 期
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy Followed by an Open-label Extension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 258
- 试验地点
- 55
- 主要终点
- Change in severity of EDS as measured by the Epworth Sleepiness Scale (ESS)
研究概览
简要总结
This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.
详细描述
This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in treating EDS, cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.
Approximately 258 participants are planned for randomization into the study. The study will consist of a Screening/Baseline Period (up to 28 days), a Double-blind Treatment Period (8 weeks), an optional Open-label Extension Period (1 year), and 30 days of safety follow-up.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a current documented diagnosis of NT1 or NT2 per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or the ICSD-3 Text Revision (ICSD-3-TR) within the last 10 years.
- •If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants or wake-promoting agents, must be on a stable dose for at least 3 months prior to Screening and agree to continue at that stable dose for the Double-blind Treatment Period of the study. As needed (PRN) use of any treatment that could affect daytime sleepiness (including but not limited to oxybates, stimulants, modafinil, and armodafinil) is not permitted.
排除标准
- •Has hypersomnia due to another medical disorder.
- •Has a history of pitolisant use within 5 half-lives prior to Screening.
- •Has a primary diagnosis of psychiatric illness, including depression, that is not well controlled (i.e., symptoms and medications have not been stable for at least 3 months prior to Screening).
- •Has any history of bipolar disorder or psychosis
- •Has acute or chronic liver disease or a history of moderate or severe hepatic impairment.
- •Has a body surface area-corrected estimated glomerular filtration rate (eGFR) <60 mL/min.
- •Has a known history of long QT syndrome or serious abnormality of the electrocardiogram (ECG).
研究组 & 干预措施
Double-Blind Treatment Period HBS-301
Experimental
HBS-301 tablets administered once daily in the morning upon wakening
干预措施: HBS-301 (Drug)
Double-blind Treatment Period Placebo
Placebo Comparator
Matching placebo tablets administered once daily in the morning upon wakening
干预措施: Placebo (Other)
Open-Label Extension Period HBS-301
Experimental
HBS-301 tablets administered once daily in the morning upon wakening
干预措施: HBS-301 (Drug)
结局指标
主要结局
Change in severity of EDS as measured by the Epworth Sleepiness Scale (ESS)
时间窗: Baseline to end of Double-Blind Treatment Period (8 weeks)
The ESS is an 8-item, 4-point rating scale.
次要结局
- Change in Weekly Rate of Cataplexy (WRC) in participants with an average WRC of ≥3 over 2 consecutive weeks at Screening(End of the Double-Blind Treatment Period (8 weeks))
- Change in sleepiness/wakefulness measured by the Maintenance of Wakefulness Test (MWT)(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- Change in fatigue as measured by the Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS-Fatigue-SF-7a)(Baseline to end of Double-Blind Treatment Period (8 weeks))
- Change in severity of EDS as measured by the ESS(Baseline through Week 1 and through Week 2 of Titration Period (1 week and 2 weeks))
- Onset of efficacy of HBS-301 compared with placebo in treating cataplexy measured by WRC in participants with an average WRC of ≥3 over 2 consecutive weeks during Screening(Baseline through Week 1 and Week 2 of the Titration Period (1 week and 2 weeks))
- Change in severity of EDS as measured by the Clinical Global Impression of Change (EDS)(Baseline to end of Double-blind Treatment Period (8 weeks))
- Change in severity of EDS as measured by the Patient Global Impression of Severity (EDS)(Time Frame: Baseline to the end of the Double-blind Treatment Period (8 weeks))
- Improvement in the severity of EDS as measured by the Patient Global Impression of Change (EDS)(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- Change in severity of cataplexy as measured by the Clinical Global Impression of Severity (Cataplexy) in participants with an average WRC of ≥3 over 2 consecutive weeks during Screening(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- Change in severity of cataplexy as measured by the Patient Global Impression of Severity (Cataplexy) in participants with an average WRC of ≥3 over 2 consecutive weeks during Screening(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- Improvement in severity of cataplexy as measured by the Patient Global Impression of Change (Cataplexy) in participants with an average WRC of ≥3 over 2 consecutive weeks during Screening(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- Change in severity of fatigue as measured by the Patient Global Impression of Severity (Fatigue)(Baseline to the end of Double-blind Treatment Period (8 weeks))
- Change in severity of fatigue as measured by the Patient Global Impression of Change (Fatigue)(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- Change in severity of narcolepsy symptoms as measured by the Narcolepsy Severity Scale (for participants with NT1) or Narcolepsy Severity Scale-2 (for participants with NT2)(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- Change in cognitive complaints as measured by the British Columbia Cognitive Complaints Inventory(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- Change in health-related quality of life as measured by the Short Form-36 physical and mental component summaries(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- Change in work productivity as measured by the Work Productivity and Activity Impairment: Narcolepsy work productivity loss score(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- Incidence of treatment-emergent adverse events(Throughout study (16 months, including Open-label Extension))
- Evaluate the pharmacokinetic concentrations of pitolisant and major identified metabolites(Throughout study (16 weeks))
研究者
研究点 (55)
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