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 304)
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT\* or CSF hypocretin-1 level)
Locations
United States
Georgia
Alkermes Investigational Site
RECRUITING
Atlanta
Alkermes Investigational Site
RECRUITING
Macon
Texas
Alkermes Investigational Site
RECRUITING
Dallas
Alkermes Investigational Site
RECRUITING
San Antonio
Alkermes Investigational Site
RECRUITING
Sugar Land
Contact Information
Primary
Director, Clinical Trial Manager
clinicaltrials@alkermes.com
888-235-8008 (US Only)
Backup
Director, Clinical Trial Manager
clinicaltrials@alkermes.com
571-599-2702 (Global)
Time Frame
Start Date: 2026-06
Estimated Completion Date: 2027-07
Participants
Target number of participants: 150
Treatments
Experimental: ALKS 2680 Dose 1
Experimental: ALKS 2680 Dose 2
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Alkermes, Inc.