A Phase 2, Long-term Extension Study of the Safety and Efficacy of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia Who Completed a Sponsored ORX750 Clinical Trial
Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study is a long-term extension (LTE) of the parent Study ORX750 0201, and will provide long-term open-label safety, tolerability, and efficacy of ORX750 in participants with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Diagnosis of narcolepsy (NT1 or NT2) or IH who was eligible for and completed the full treatment period in the eligible parent study ORX750-0201 (CRYSTAL-1)
• Is willing and able to adhere to additional protocol requirements
Locations
United States
Alabama
Auburn, alabama
RECRUITING
Auburn
California
Santa Ana, California
RECRUITING
Santa Ana
Florida
Miami, Florida
RECRUITING
Miami
Orlando, Florida
RECRUITING
Orlando
Winter Park, FL
RECRUITING
Winter Park
Georgia
Atlanta, Georgia
RECRUITING
Atlanta
Stockbridge, GA
RECRUITING
Atlanta
Michigan
Sterling Heights, Michigan
RECRUITING
Sterling Heights
North Carolina
Denver, North Carolina
RECRUITING
Denver
Huntersville, North Carolina
RECRUITING
Huntersville
Nevada
Hendersen, Navada
RECRUITING
Henderson
Henderson, Nevada
RECRUITING
Henderson
Ohio
Cincinnati, Ohio
RECRUITING
Cincinnati
Dublin
RECRUITING
Dublin
Pennsylvania
Abington, Pennsylvania
RECRUITING
Abington
Willow Grove, Pennsylvania
RECRUITING
Willow Grove
South Carolina
North Charleston, South Carolina
RECRUITING
North Charleston
Texas
Austin, Texas
RECRUITING
Austin
El Paso, Texas
RECRUITING
El Paso
Other Locations
Canada
Toronto
RECRUITING
Toronto
Italy
Bologna
RECRUITING
Bologna
Verona
RECRUITING
Verona
Spain
Álava, Spain
RECRUITING
Álava
Móstoles, Madrid
RECRUITING
Móstoles
Contact Information
Primary
Orexin Centessa Program Lead
ORX750-LTE@centessa.com
617-468-5770
Time Frame
Start Date: 2025-08-12
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 90
Treatments
Experimental: Narcolepsy Type 1
Narcolepsy Type 1 (Open Label)
Experimental: Narcolepsy Type 2
Narcolepsy Type 2 (Open Label)
Experimental: Idiopathic Hypersomnia
Idiopathic Hypersomnia (Open Label)
Related Therapeutic Areas
Sponsors
Leads: Centessa Pharmaceuticals (UK) Limited