ALKS 2680 in adults with narcolepsy type 1: see if it helps daytime sleepiness and cataplexy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial compares two doses of ALKS 2680 to placebo in adults with narcolepsy type 1. Participants will be randomly assigned to receive one of the two ALKS 2680 doses or placebo over a defined treatment period. The study aims to measure changes in daytime sleepiness, cataplexy frequency, and overall narcolepsy symptoms, while monitoring safety and tolerability. Eligibility requires a diagnosis of narcolepsy type 1 confirmed by standard sleep tests or CSF hypocretin-1 levels, with exclusions for other sleep disorders or recent interventional therapies. Conduct locations are Alkermes investigational sites in Florida.

Why it matters

Who can join: the full rules

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.

Where it's running

• Alkermes Investigational Site
  Brandon, Florida, United States Recruiting
• Alkermes Investigational Site
  Miami, Florida, United States Recruiting
• Alkermes Investigational Site
  Winter Park, Florida, United States Recruiting
• Alkermes Investigational Site
  Atlanta, Georgia, United States Recruiting
• Alkermes Investigational Site
  Macon, Georgia, United States Recruiting
• Alkermes Investigational Site
  Lansing, Michigan, United States Recruiting

Study contacts

• Study coordinator: Director, Clinical Trial Manager
• Email: clinicaltrials@alkermes.com
• Phone: 888-235-8008 (US Only)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.