ALKS 2680-203 Idiopathic Hypersomnia

A Phase 2, randomised, parallel-group, double-blind, dose-range-finding study to evaluate the safety and efficacy of ALKS 2680 in subjects with Idiopathic Hypersomnia

Study Population

Approximately 96 participants are planned to be randomized into this study

Idiopathic Hypersomnia is a sleep disorder characterised by excessive daytime sleepiness, which can lead to unrefreshing prolonged naps, brain fog and sleep inertia.

ALKS 2680 is a new investigational drug that is classified as an orexin 2 receptor agonist. Orexin is a substance that helps control sleep/wake cycles. ALKS 2680 works similarly to orexin and may improve excessive sleepiness in people with Idiopathic Hypersomnia.

Eligible subjects must be:

18 to 70 years of age

have a diagnosis of Idiopathic Hypersomnis confirmed by diagnostic evaluations (PSG, MSLT, Actigraphy)

have an Excessive Daytime Sleepiness (EDS) score >12

Subjects must be able to safely discontinue any medications prescribed for the management of IH symptoms for the duration of the study

Subjects with other significant sleep disorders or conditions that influence the sleep/wake cycle will be ineligible, and women who are pregnant or lactating will not be eligible to participate in the study.

Study Visits

A total of 15 visits over a 15 week period.

The planned study duration comprises a Screening Period (2-5 weeks), the Treatment Period (8 weeks), and a Safety Follow Up period (2 weeks)

There are 7 onsite visits including 2 overnight visits, and 6 phone visits.

Study Requirements

Subjects will receive study drug taken as an oral tablet once daily

Assessments include Ophthalmology review, ECG, Blood tests

Questionnaires, neuropsychological assessments, actigraphy

2 overnight sleep studies (PSG, MWT)

Clinical Trials Registry:

tba