An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia
Status: Recruiting
Location: See all (43) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible studies are ALKS 2680-201 (Vibrance-1), ALKS 2680-202 (Vibrance-2) and ALKS 2680-203 (Vibrance-3)
• Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, as applicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for the duration of study (for all subjects)
Locations
United States
Arkansas
Alkermes Investigational Site
RECRUITING
Little Rock
Arizona
Alkermes Investigator Site
RECRUITING
Phoenix
California
Alkermes Investigational Site
RECRUITING
Los Angeles
Alkermes Investigator Site
RECRUITING
San Francisco
Alkermes Investigational Site
RECRUITING
Stanford
Colorado
Alkermes Investigational Site
RECRUITING
Colorado Springs
Florida
Alkermes Investigational Site
RECRUITING
Brandon
Alkermes Investigational Site
RECRUITING
Miami
Alkermes Investigational Site
RECRUITING
Winter Park
Georgia
Alkermes Investigational Site
RECRUITING
Atlanta
Alkermes Investigational Site
RECRUITING
Macon
Alkermes Investigational Site
RECRUITING
Stockbridge
Illinois
Alkermes Investigational Site
RECRUITING
Peoria
Michigan
Alkermes Investigational Site
RECRUITING
Lansing
Alkermes Investigational Site
RECRUITING
Sterling Heights
North Carolina
Alkermes Investigational Site
RECRUITING
Denver
Alkermes Investigational Site
RECRUITING
Huntersville
Nebraska
Alkermes Investigational Site
RECRUITING
Lincoln
New Jersey
Alkermes Investigational Site
RECRUITING
Middletown
Ohio
Alkermes Investigational Site
RECRUITING
Canton
Alkermes Investigational Site
RECRUITING
Cincinnati
Alkermes Investigational Site
RECRUITING
Cincinnati
Alkermes Investigational Site
RECRUITING
Dublin
Pennsylvania
Alkermes Investigational Site
RECRUITING
Abington
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
Australia
Alkermes Investigational Site
RECRUITING
Bedford Park
Alkermes Investigational Site
RECRUITING
Sydney
Belgium
Alkermes Investigational Site
RECRUITING
Alken
Alkermes Investigational Site
RECRUITING
Bruges
Alkermes Investigational Site
RECRUITING
Namur
France
Alkermes Investigational Site
RECRUITING
Bordeaux
Alkermes Investigational Site
RECRUITING
Montpellier
Italy
Alkermes Investigational Site
RECRUITING
Bologna
Alkermes Investigational Site
RECRUITING
Milan
Alkermes Investigational Site
RECRUITING
Verona
Netherlands
Alkermes Investigational Site
RECRUITING
Zwolle
Spain
Alkermes Investigational Site
RECRUITING
Barcelona
Alkermes Investigational Site
RECRUITING
Madrid
Alkermes Investigational Site
RECRUITING
Madrid
Contact Information
Primary
Director, Global Clinical Services
clinicaltrials@alkermes.com
888-235-8008 (US Only)
Backup
Director, Global Clinical Services
clinicaltrials@alkermes.com
571-599-2702 (Global)
Time Frame
Start Date: 2025-01-27
Estimated Completion Date: 2028-06
Participants
Target number of participants: 256
Treatments
Experimental: Narcolepsy Type 1 (NT1)
Experimental: Narcolepsy Type 2 (NT2)
Experimental: Idiopathic Hypersomnia (IH)
Related Therapeutic Areas
Sponsors
Leads: Alkermes, Inc.