A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of FT218 in the Treatment of Idiopathic Hypersomnia (IH)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Avadel
- 入组人数
- 157
- 试验地点
- 7
- 主要终点
- Epworth Sleepiness Scale (ESS)
研究概览
简要总结
This is a double-blind, placebo-controlled, randomized withdrawal, multicenter study of the efficacy and safety of FT218. FT218 drug product is a once-nightly formulation of sodium oxybate for extended-release oral suspension. The study will enroll subjects who are diagnosed with idiopathic hypersomnia. Subjects will be eligible to enroll regardless of current treatment with oxybate therapy or stimulants/alerting agents at study entry. The estimated total duration of study for each subject is approximately 18 weeks, including the Screening period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
For the double-blind, randomized withdrawal portion of the study, the subject and all members of the study team will remain blinded to treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of idiopathic hypersomnia
- •Total ESS score at Screening > 11 if not on prior oxybate
- •Average nightly total sleep time of > 7 hours
- •May use stimulants/alerting agents but dose and regimen must have been stable for 2 months prior to Screening, and remain stable until the double-blind, randomized withdrawal visit
- •Females of childbearing potential must use highly effective contraception for 2 months prior to Baseline, throughout the study, and for 30 days after the last dose of study drug
- •Males with female partners of childbearing potential must use condoms throughout the study and for 30 days after the last dose of study drug
- •Willing and able to provide informed consent and comply with the requirements of the study
排除标准
- •Pregnant, nursing or lactating females
- •Hypersomnia due to another medical, behavioral, sleep, or psychiatric condition
- •Untreated or incompletely treated sleep apnea in patients with an apnea-hypopnea index (AHI) ≥ 15 by American Academy of Sleep Medicine (AASM) 1A criteria
- •Clinically significant parasomnias
- •History or presence of seizures, head trauma, succinic semialdehyde dehydrogenase deficiency, uncontrolled hypothyroidism, and/or significant hepatic impairment
- •History or presence of bipolar and related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders
- •Ongoing or past (within 1 year) major depressive episode
- •At risk for suicide or history of suicide attempt
- •If not on oxybate at Screening, treatment or planned treatment with any central nervous system (CNS) sedating agents during study
- •Current or past substance use disorder (including alcohol or cannabinoids)
- •Excessive caffeine consumption (> 600 mg/day)
- •Prior treatment with either FT218 or LUMRYZ
研究组 & 干预措施
Placebo
Placebo equivalent administered orally once nightly
干预措施: Placebo (Other)
FT218
FT218 at stable dose (selected during earlier titration) administered orally once nightly
干预措施: FT218 (Drug)
结局指标
主要结局
Epworth Sleepiness Scale (ESS)
时间窗: End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period]
Change in total ESS score
次要结局
- Patient Global Impression of change (PGI-C)(End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period])
- Idiopathic Hypersomnia Severity Scale (IHSS)(End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period])
- Clinical Global Impression of change (CGI-C)(End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period])
- Functional Outcomes of Sleep Questionnaire (FOSQ-10)(End of stable dose visit to end of double-blind, randomized withdrawal visit [Week 12 to Week 14; 2 week period])