NCT07502443 A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2
| NCT ID | NCT07502443 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Alkermes, Inc. |
| Condition | Narcolepsy Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 176 participants |
| Start Date | 2026-04-22 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 176 participants in total. It began in 2026-04-22 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, and disease symptoms in participants with Narcolepsy Type 2 (NT2) 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 the following: 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 NT2 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT). Exclusion Criteria: * Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle. * Has a history or presence 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 2680-202 are not eligible for enrollment. * Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
Contact & Investigator
Study Director, MD
STUDY DIRECTOR
Alkermes, Inc.
Frequently Asked Questions
Who can join the NCT07502443 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Narcolepsy Type 2. 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 NCT07502443 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 176 participants.
Is NCT07502443 currently recruiting?
Yes, NCT07502443 is actively recruiting participants. Contact the research team at clinicaltrials@alkermes.com for enrollment information.
Where is the NCT07502443 trial being conducted?
This trial is being conducted at Cullman, United States, Phoenix, United States, Los Angeles, United States, Boulder, United States and 11 additional locations.
Who is sponsoring the NCT07502443 clinical trial?
NCT07502443 is sponsored by Alkermes, Inc.. The principal investigator is Study Director, MD at Alkermes, Inc.. The trial plans to enroll 176 participants.