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 location...
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
North Carolina
Site Number 1
RECRUITING
Huntersville
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