ALKS 2680 for reducing daytime sleepiness and cataplexy in adults with narcolepsy type 1

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 interventional study enrolls adults with narcolepsy type 1 confirmed by ICSD-3-TR diagnostic testing (polysomnography/MSLT or CSF hypocretin-1). Participants will receive one of two doses of ALKS 2680 tablets or placebo and will be monitored for changes in daytime sleepiness, frequency of cataplexy, and other disease symptoms. Efficacy and safety endpoints compare symptom changes between dose groups and placebo over the treatment period. The study is sponsored by Alkermes and conducted at Alkermes investigational sites in Brandon, FL; Macon, GA; and Lansing, MI.

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
  Cullman, Alabama, United States Recruiting
• Alkermes Investigational Site
  Phoenix, Arizona, United States Recruiting
• Alkermes Investigational Site
  Los Angeles, California, United States Recruiting
• Alkermes Investigational Site
  Boulder, Colorado, United States Recruiting
• Alkermes Investigational Site
  Brandon, Florida, United States Recruiting
• Alkermes Investigational Site
  Miami, Florida, 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.