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Recruiting Phase 2 NCT06843590

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

Phase 2 – studying effectiveness and dosage
Conditions: Idiopathic Hypersomnia

Sponsor: Alkermes, Inc.

trial.available_in: БГ
Overview
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
Who can participate
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
Locations 8
Australia (1)
Alkermes Investigator Site
Sydney , New South Wales
Belgium (1)
Alkermes Investigator Site
Alken
Czech Republic (1)
Alkermes Investigator Site
Prague
France (1)
Alkermes Investigator Site
Bordeaux , Gironde
Italy (1)
Alkermes Investigator Site
Bologna
Netherlands (1)
Alkermes Investigator Site
Zwolle
Spain (1)
Alkermes Investigator Site
Barcelona
United States (1)
Alkermes Investigator Site
Cullman , Alabama
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No
Start date
22.05.2025
Completion date
01.06.2026
Registry ID
NCT06843590
Source
anzctr
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