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)
Status: Recruiting
Location: See all (17) 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
California
Alkermes Investigational Site
RECRUITING
Los Angeles
Colorado
Alkermes Investigational Site
RECRUITING
Boulder
Florida
Alkermes Investigational Site
RECRUITING
Brandon
Alkermes Investigational Site
RECRUITING
Miami
Alkermes Investigational Site
RECRUITING
Winter Park
Georgia
Alkermes Investigational Site
RECRUITING
Macon
Massachusetts
Alkermes Investigational Site
RECRUITING
Newton
Michigan
Alkermes Investigational Site
RECRUITING
Lansing
Missouri
Alkermes Investigational Site
RECRUITING
St Louis
Ohio
Alkermes Investigational Site
RECRUITING
Cincinnati
Pennsylvania
Alkermes Investigational Site
RECRUITING
Wyomissing
South Carolina
Alkermes Investigational Site
RECRUITING
Columbia
Texas
Alkermes Investigational Site
RECRUITING
Austin
Alkermes Investigational Site
RECRUITING
San Antonio
Alkermes Investigational Site
RECRUITING
Sugar Land
Other Locations
Canada
Alkermes Investigational Site
RECRUITING
Markham
Alkermes Investigational Site
RECRUITING
Toronto
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: 2026-04-06
Estimated Completion Date: 2027-06
Participants
Target number of participants: 150
Treatments
Placebo_comparator: Placebo
Placebo arm
Experimental: ALKS 2680 Dose 1
Oral tablet containing ALKS 2680
Experimental: ALKS 2680 Dose 2
Oral tablet containing ALKS 2680
Related Therapeutic Areas
Sponsors
Leads: Alkermes, Inc.