ALKS 2680 for reducing daytime sleepiness and cataplexy in adults with narcolepsy type 1
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 Study 302)
This study will test whether ALKS 2680 tablets can reduce daytime sleepiness, cataplexy, and other symptoms in adults with narcolepsy type 1.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Alkermes, Inc. Industry-sponsored |
| Locations | 9 sites (Brandon, Florida and 8 other locations) |
| Trial ID | NCT07455383 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults diagnosed with narcolepsy type 1 according to ICSD-3-TR and confirmed by PSG/MSLT or low CSF hypocretin-1 levels are ideal candidates.
Not a fit: People with other comorbid sleep disorders, significant uncontrolled medical conditions, recent participation in other interventional trials, or those who are pregnant or breastfeeding may not benefit or be eligible.
Why it matters
Potential benefit: If successful, ALKS 2680 could reduce daytime sleepiness and cataplexy, improving daily function and quality of life for people with narcolepsy type 1.
How similar studies have performed: Earlier-phase studies of ALKS 2680 suggested potential benefit, but this Phase 3 trial is designed to confirm efficacy and safety in a larger group.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brandon, Florida and 8 other locations
- Alkermes Investigational Site — Brandon, Florida, United States (Recruiting)
- Alkermes Investigational Site — Macon, Georgia, United States (Recruiting)
- Alkermes Investigational Site — Lansing, Michigan, United States (Recruiting)
- Alkermes Investigational Site — St Louis, Missouri, United States (Recruiting)
- Alkermes Investigational Site — Cincinnati, Ohio, United States (Recruiting)
- Alkermes Investigational Site — Wyomissing, Pennsylvania, United States (Recruiting)
- Alkermes Investigational Site — Columbia, South Carolina, United States (Recruiting)
- Alkermes Investigational Site — Austin, Texas, United States (Recruiting)
- Alkermes Investigational Site — Sugar Land, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Director, Clinical Trial Manager
- Email: clinicaltrials@alkermes.com
- Phone: 888-235-8008 (US Only)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.