NCT07455383 A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
| NCT ID | NCT07455383 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Alkermes, Inc. |
| Condition | Narcolepsy Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-04-06 |
| Primary Completion | 2027-05 |
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.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 150 participants in total. It began in 2026-04-06 with a primary completion date of 2027-05.
⚠ 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 decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
Eligibility Criteria
Inclusion Criteria: * Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT\* or CSF hypocretin-1 level). 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 participant safety, interfere with any study assessment, or affect the participant's ability to complete the study. * Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-201 are not eligible for enrollment. * Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
Contact & Investigator
Medical Director, MD
STUDY DIRECTOR
Alkermes, Inc.
Frequently Asked Questions
Who can join the NCT07455383 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Narcolepsy Type 1. 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 NCT07455383 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 150 participants.
Is NCT07455383 currently recruiting?
Yes, NCT07455383 is actively recruiting participants. Contact the research team at clinicaltrials@alkermes.com for enrollment information.
Where is the NCT07455383 trial being conducted?
This trial is being conducted at Cullman, United States, Los Angeles, United States, Boulder, United States, Brandon, United States and 11 additional locations.
Who is sponsoring the NCT07455383 clinical trial?
NCT07455383 is sponsored by Alkermes, Inc.. The principal investigator is Medical Director, MD at Alkermes, Inc.. The trial plans to enroll 150 participants.