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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
Who can join
Ages 18 to 65 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
About the study
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).
What is being tested
- ORX750 (drug)
- ORX750 (drug)
- ORX750 (drug)
Sponsor: Centessa Pharmaceuticals (UK) Limited · Participants: 90 · Started: Aug 12, 2025
Contact the study team
- Orexin Centessa Program Lead · Phone: 617-468-5770
Official record on ClinicalTrials.gov — NCT07096674
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.