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)
Alkermes, Inc.
Summary
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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 comple…
Interventions
- DrugALKS 2680 Dose 1
Participants will receive ALKS 2680 tablets, orally, daily, for 12 weeks
- DrugALKS 2680 Dose 2
Participants will receive ALKS 2680 tablets, orally, daily, for 12 weeks
- DrugPlacebo
Participants will receive ALKS 2680-matching placebo tablets, orally, for 12 weeks.
Locations (9)
- Alkermes Investigational SiteBrandon, Florida
- Alkermes Investigational SiteMacon, Georgia
- Alkermes Investigational SiteLansing, Michigan
- Alkermes Investigational SiteSt Louis, Missouri
- Alkermes Investigational SiteCincinnati, Ohio
- Alkermes Investigational SiteWyomissing, Pennsylvania