2025-524711-36-00招募中3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
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
- 116
- 试验地点
- 38
- 主要终点
- Change in Epworth Sleepiness Scale from baseline to Week 12 by dose level
研究概览
简要总结
To evaluate the efficacy of ALKS 2680 for the treatment of excessive daytime sleepiness (EDS) in participants with Narcolepsy Type 1 (NT1)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Is 18 to 70 years of age at the time of informed consent.
- •Is willing and able to provide informed consent before study participation, as required by local regulations and IEC requirements.
- •Has a body mass index ≥18 and ≤40 kg/m2 at Visit
- •As assessed by the Investigator based on clinical assessments and medical history, is experiencing an unsatisfactory clinical response and/or side effect(s) from any medications prescribed for the management of narcolepsy symptoms (including EDS), and can safely discontinue any medications for the duration of study and adhere to the respective washout periods detailed in Section 6.9.
- •Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including the following: a. Lifestyle considerations and restrictions b. Adherence to contraception guidance
- •Is willing and able to adhere to actigraphy, cataplexy diary and sleep diary requirements during Screening.
- •If receiving treatment for obstructive sleep apnea (OSA), adherence to primary OSA therapy over the 30 days prior to Visit 1, as confirmed by the Investigator, and throughout the study, including during overnight visits. Adherence is defined in the Protocol
排除标准
- •Has poorly controlled and clinically significant sleep-disordered breathing, at the most recent diagnostic sleep assessment or at Visit 4 (in accordance with the American Academy of Sleep Medicine (AASM) Scoring Manual [rule 1B]): a. Has apnea-hypopnea index ≥15 per hour. b. If receiving treatment for OSA, has an average apnea-hypopnea index ≥10 per hour over the 30 days prior to Visit
- •c. Has central apnea index >5 per hour.
- •Presence of laboratory abnormalities at Visit 1 as detailed in the Protocol
- •Is currently taking or has taken in the last 6 months antidepressant medications for any reason other than cataplexy control. Anti-cataplexy medications will be washed-out during the Screening Period.
- •Is currently pregnant, breastfeeding, or is planning to become pregnant during the study.
- •Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit
- •Participants previously enrolled in Study ALKS 2680-201 are not eligible for enrollment.
- •Is employed by Alkermes, the CRO, or study site (permanent, temporary contract worker, or designee responsible for the conduct of the study) or is immediate family (ie, a spouse, parent, sibling, or child, whether biological or legally adopted) of an Alkermes, CRO, or study site employee.
- •Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle as detailed in the Protocol
- •Has a significant cardiovascular disease during the Screening Period, or within 2 years prior to Visit 1, as detailed in the Protocol
- •Has a major psychiatric or substance use disorder established in accordance with Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition), as detailed in the Protocol
- •Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise participant safety, interfere with any study assessment, or affect the participant’s ability to complete the study. This includes but is not necessarily limited to another significant neurological disorder, including dementia, neurodegenerative disorders, stroke, or seizures (excluding isolated pediatric febrile seizures).
- •Has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs (ie, a history of malabsorption or any surgical intervention). Any history of Roux-en-Y gastric bypass and any other gastric surgical intervention that may influence the absorption of drugs is considered exclusionary.
- •Has a history of cancer (treated or untreated) in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without the need for further treatment, or basal cell cancer; these participants may be included after approval by the Sponsor or designee).
- •Has known risk (eg, occludable narrow anterior chamber angle) or history of narrow-angle glaucoma.
- •Has a positive alcohol breath test or urine drug screen for drugs of potential abuse at Visit 4.
研究组 & 干预措施
ALKS 2680, ALKS 2680, ALKS 2680
Test
干预措施: ALKS 2680 (Drug)
Placebo to match alks 2680/alixorexton
Placebo
干预措施: Placebo to match alks 2680/alixorexton (Drug)
结局指标
主要结局
Change in Epworth Sleepiness Scale from baseline to Week 12 by dose level
Change in Epworth Sleepiness Scale from baseline to Week 12 by dose level
次要结局
- Change in Mean Sleep Latency on Maintenance of Wakefulness Test from baseline to Week 12 by dose level
- Weekly cataplexy rate (WCR) at Week 12 by dose level
- Change in select patient-reported outcome measures from baseline to Week 12 by dose level
研究者
ALKS Project Lead
Scientific
Alkermes Inc.
研究点 (38)
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