Recruiting NCT06843590
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ALKS 2680, Placebo.
- Who it may be relevant to
- Registry conditions: Idiopathic Hypersomnia. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Belgium, Czechia, France +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
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
Interventions
- Drug ALKS 2680
Oral tablet containing ALKS 2680 for daily, oral administration - Drug Placebo
Oral placebo tablet for daily administration
Primary outcome measures
- Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level [Time frame: Up to 8 weeks]
Secondary outcome measures (2)
- Change in Idiopathic Hypersomnia Severity Scale (IHSS) from baseline to Week 8 by dose level [Time frame: Up to 8 weeks]
- Incidence of treatment emergent adverse events [Time frame: Up to 10 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 34 centers
- Alkermes Investigator Site — Cullman
- Alkermes Investigator Site — Phoenix
- Alkermes Investigator Site — Little Rock
- Alkermes Investigator Site — Los Angeles
- Alkermes Investigator Site — Redwood City
- Alkermes Investigator Site — San Francisco
- Alkermes Investigational Site — Boulder
- Alkermes Investigator Site — Colorado Springs
- … and 26 more centers
Australia · 3 centers
- Alkermes Investigator Site — Sydney
- Alkermes Investigator Site — Bedford Park
- Alkermes Investigator Site — Clayton
France · 3 centers
- Alkermes Investigator Site — Bordeaux
- Alkermes Investigator Site — Montpellier
- Alkermes Investigator Site — Grenoble
Italy · 3 centers
- Alkermes Investigator Site — Bologna
- Alkermes Investigator Site — Milan
- Alkermes Investigator Site — Verona
Spain · 3 centers
- Alkermes Investigator Site — Barcelona
- Alkermes Investigator Site — Madrid
- Alkermes Investigator Site — Madrid
Belgium · 2 centers
- Alkermes Investigator Site — Alken
- Alkermes Investigator Site — Namur
Czechia · 1 center
- Alkermes Investigator Site — Prague
Netherlands · 1 center
- Alkermes Investigator Site — Zwolle
Identifiers
NCT: NCT06843590 · ALKS 2680-203