NCT06843590 A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia
| NCT ID | NCT06843590 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Alkermes, Inc. |
| Condition | Idiopathic Hypersomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2025-05-22 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 126 participants in total. It began in 2025-05-22 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Medical Director
STUDY DIRECTOR
Alkermes, Inc.
Frequently Asked Questions
Who can join the NCT06843590 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Idiopathic Hypersomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06843590 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06843590 currently recruiting?
Yes, NCT06843590 is actively recruiting participants. Contact the research team at clinicaltrials@alkermes.com for enrollment information.
Where is the NCT06843590 trial being conducted?
This trial is being conducted at Cullman, United States, Phoenix, United States, Little Rock, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT06843590 clinical trial?
NCT06843590 is sponsored by Alkermes, Inc.. The principal investigator is Medical Director at Alkermes, Inc.. The trial plans to enroll 126 participants.