A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
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
Centessa Pharmaceuticals (UK) Limited
90 participants
Aug 12, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- 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
Exclusion Criteria2
- Development of any new disease/disorder that in the opinion of the investigator would make the participant unable to continue the study
- Unable to refrain from excluded medications, including those used for treatment of narcolepsy or idiopathic hypersomnia
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Interventions
Oral ORX750
Oral ORX750
Oral ORX750
Locations(14)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07096674