ALKS 2680 for adults with Narcolepsy Type 2
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 (Brilliance NT2 Study 303)
PHASE3 · Alkermes, Inc. · NCT07502443
This will test whether ALKS 2680 tablets reduce daytime sleepiness and other symptoms in adults with Narcolepsy Type 2 compared with placebo.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Alkermes, Inc. (industry) |
| Locations | 8 sites (Brandon, Florida and 7 other locations) |
| Trial ID | NCT07502443 on ClinicalTrials.gov |
What this trial studies
This phase 3, randomized interventional trial compares three doses of ALKS 2680 tablets with placebo in adults diagnosed with Narcolepsy Type 2. Participants must have NT2 confirmed by PSG/MSLT and will follow study requirements including actigraphy, sleep diaries, and adherence to any primary OSA therapy. The trial measures changes in daytime sleepiness and core disease symptoms across treatment arms. Study visits occur at Alkermes investigational sites in Florida, Georgia, and Michigan.
Who should consider this trial
Good fit: Adults with a confirmed Narcolepsy Type 2 diagnosis per ICSD-3-TR (by PSG/MSLT), who can follow study procedures and any required sleep therapy, are the ideal candidates.
Not a fit: People with other comorbid sleep disorders, significant uncontrolled medical conditions, or those who cannot comply with protocol requirements are unlikely to benefit from or be eligible for the trial.
Why it matters
Potential benefit: If successful, ALKS 2680 could lessen daytime sleepiness and other NT2 symptoms, improving daily function for affected adults.
How similar studies have performed: Early-phase studies of orexin-2 receptor agonists, including prior testing of ALKS 2680, have shown promising effects on wakefulness, but large-scale phase 3 confirmation is still needed.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brandon, Florida and 7 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 (NOT_YET_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.
Conditions: Narcolepsy Type 2, NT2, Sleep, Sleep disorder, orexin-2 receptor agonist, excessive daytime sleepiness