NCT07500090招募中3 期
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) Followed by an Open-label Extension
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 248
- 试验地点
- 44
- 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 adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).
详细描述
Approximately 248 participants are planned for randomization in 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 (OLE) 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 IH per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or Text Revision (ICSD-3-TR) criteria with confirmatory polysomnogram (PSG) with multiple sleep latency test (MSLT; and if applicable, a 24-hour PSG report or an actigraphy report with sleep log) on file that led to the diagnosis and was completed within the last 10 years.
- •Has moderate to very severe symptoms of IH.
- •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 use of any treatment that could affect daytime sleepiness (including but not limited to stimulants, modafinil, and armodafinil) used on an as-needed basis 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.
- •Has a history of moderate or severe hepatic impairment.
- •Has a body surface area (BSA)-corrected estimated glomerular filtration rate (eGFR) <60 mL/min.
- •Has a known history of long QT syndrome or any significant history of a 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 tablet (Drug)
Double-blind Treatment Period Placebo
Placebo Comparator
Matching placebo tablets administered once daily in the morning upon wakening
干预措施: Placebo (Drug)
Open-label Extension Period HBS-301
Experimental
HBS-301 tablets administered once daily in the morning upon wakening
干预措施: HBS-301 tablet (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 the end of the Double-blind Treatment Period (8 weeks)
The ESS is an 8-item, 4-point rating scale.
To evaluate the efficacy of HBS-301 compared with placebo in treating IH symptoms
时间窗: Baseline to the end of the Double-blind Treatment Period (8 weeks)
Change in severity of IH symptoms as measured by the Idiopathic Hypersomnia Severity Scale
次要结局
- Change in severity of IH symptoms as measured by the Idiopathic Hypersomnia Severity Scale (IHSS)(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- Change in sleep inertia as measured by the Sleep Inertia Questionnaire (SIQ)(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(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- Change in severity of EDS as measured by the Epworth Sleepiness Scale(Baseline through Week 1 and Week 2 of the Titration Period (1 week and 2 weeks))
- Change in severity of IH symptoms as measured by the IHSS(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 Severity (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)(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- Improvement in severity of EDS as measured by the Patient Global Impression of Change (EDS)(End of the Double-blind Treatment Period (8 weeks))
- Change in severity of IH symptoms as measured by the Clinical Global Impression of Severity (IH)(Baseline to end of Double-blind Treatment Period (8 weeks))
- Change in severity of IH symptoms as measured by the Patient Global Impression of Severity (IH)(Baseline to end of Double-blind Treatment Period (8 weeks))
- Improvement in severity of IH symptoms as measured by the Patient Global Impression of Change (IH)(Baseline to end of Double-blind Treatment Period (8 weeks))
- Change in severity of sleep inertia as measured by the Patient Global Impression of Severity (Sleep Inertia)(Baseline to end of Double-blind Treatment Period (8 weeks))
- Improvement in severity of sleep inertia as measured by the Patient Global Impression of Change (Sleep Inertia)(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 of the end of the Double-blind Treatment Period (8 weeks))
- Improvement in severity of fatigue as measured by the Patient Global Impression of Change (Fatigue)(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 Health Survey-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: Idiopathic Hypersomnia 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 OLE))
- To evaluate the efficacy of HBS-301 compared with placebo in treating EDS(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- To evaluate the efficacy of HBS-301 compared with placebo in treating sleep inertia(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- To evaluate the efficacy of HBS-301 compared with placebo on fatigue(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- To evaluate the onset of efficacy of HBS-301 compared with placebo in treating EDS(Baseline through Week 1 and Week 2 of the Titration Period (1 week and 2 weeks))
- To evaluate the onset of efficacy of HBS-301 compared to placebo in treating IH symptoms(Baseline through Week 1 and Week 2 of the Titration Period (1 week and 2 weeks))
- To evaluate the efficacy of HBS-301 compared with placebo in treating IH symptoms(Baseline to end of Double-blind Treatment Period (8 weeks))
- To evaluate the efficacy of HBS-301 compared with placebo in treating sleep-related impairment(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- To evaluate the efficacy of HBS-301 compared with placebo on severity of fatigue(Baseline of the end of the Double-blind Treatment Period (8 weeks))
- To evaluate the efficacy of HBS-301 compared with placebo on overall severity of EDS(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- To evaluate the efficacy of HBS-301 compared with placebo on severity of sleep inertia(Baseline to end of Double-blind Treatment Period (8 weeks))
- To evaluate the efficacy of HBS-301 compared with placebo on cognitive complaints(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- To evaluate the efficacy of HBS-301 compared with placebo on overall health-related quality of life(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- To evaluate the efficacy of HBS-301 compared with placebo on work productivity(Baseline to the end of the Double-blind Treatment Period (8 weeks))
- To evaluate the safety of HBS-301(Throughout study (16 months including OLE))
- To evaluate the pharmacokinetic concentrations of pitolisant and major identified metabolites(Throughout study (16 weeks))
研究者
研究点 (44)
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