Idiopathic Hypersomnia
Conditions
Keywords
Idiopathic Hypersomnia, IH, sleep, sleep disorder, orexin-2 receptor agonist, excessive daytime sleepiness
Brief summary
The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets
Interventions
DRUGALKS 2680
Oral tablet containing ALKS 2680 for daily, oral administration
DRUGPlacebo
Oral placebo tablet for daily administration
Sponsors
Alkermes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits. * Meets the diagnostic criteria of Idiopathic Hypersomnia according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG/MSLT/actigraphy) within the previous 10 years
Exclusion criteria
* Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle * 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 subject safety, interfere with any study assessment, or affect the subject's ability to complete the study * Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1 * Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level | Up to 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in Idiopathic Hypersomnia Severity Scale (IHSS) from baseline to Week 8 by dose level | Up to 8 weeks |
| Incidence of treatment emergent adverse events | Up to 10 weeks |
Countries
Australia, Belgium, Czechia, France, Italy, Netherlands, Spain, United States
Contacts
CONTACTDirector, Global Clinical Services
STUDY_DIRECTORMedical Director
Alkermes, Inc.
Outcome results
None listed