ALKS 2680 for daytime sleepiness in adults with narcolepsy type 1

Who can take part

• 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 1
• 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 6.9.1
• 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

Who cannot take part

• 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 1. c. Has central apnea index >5 per hour
• 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 enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-201 are not eligible for enrollment
• Has a significant cardiovascular disease during the Screening Period, or within 2 years prior to Visit 1, as detailed in the Protocol
• Has a positive alcohol breath test or urine drug screen for drugs of potential abuse at Visit 4
• Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle 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
• Presence of laboratory abnormalities at Visit 1 as detailed in the Protocol
• Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
• 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