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Recruiting Phase 2 NCT07096674

A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

Trial Parameters

Condition Narcolepsy Type 1
Sponsor Centessa Pharmaceuticals (UK) Limited
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 90
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-08-12
Completion 2026-04-30
Interventions
ORX750ORX750ORX750

Brief 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 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

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