Clinical trial NCT06843590: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia
Official title: A Phase 2, Randomized, Parallel-Group, Double-Blind, Dose-Range-Finding Study to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Idiopathic Hypersomnia (Vibrance-3)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Idiopathic Hypersomnia
Keywords: Idiopathic Hypersomnia
IH
sleep
sleep disorder
orexin-2 receptor agonist
excessive daytime sleepiness
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-25
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Change in Idiopathic Hypersomnia Severity Scale (IHSS) from baseline to Week 8 by dose level
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Alkermes Investigational Site
state: Colorado
city: Lansing
country: United States
facility: Alkermes Investigational Site
state: Michigan
city: Huntersville
country: United States
facility: Alkermes Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Wyomissing
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Alkermes Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Alkermes Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Alkermes Investigational Site
state: Texas
Study officials:
affiliation: Alkermes, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: