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

Recruiting now · Phase 2

Conditions studied: Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia

In brief

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).

Key facts

Study ID

NCT07096674

Run by

Centessa Pharmaceuticals (UK) Limited

People needed

90

Starts

2025-08-12

Expected to finish

2026-04-30

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Auburn, alabama — Auburn, Alabama, United States (enrolling)
• Santa Ana, California — Santa Ana, California, United States (enrolling)
• Miami, Florida — Miami, Florida, United States (enrolling)
• Orlando, Florida — Orlando, Florida, United States (enrolling)
• Winter Park, FL — Winter Park, Florida, United States (enrolling)
• Stockbridge, GA — Atlanta, Georgia, United States (enrolling)
• Atlanta, Georgia — Atlanta, Georgia, United States (enrolling)
• Sterling Heights, Michigan — Sterling Heights, Michigan, United States (enrolling)
• Hendersen, Navada — Henderson, Nevada, United States (enrolling)
• Henderson, Nevada — Henderson, Nevada, United States (enrolling)
• Denver, North Carolina — Denver, North Carolina, United States (enrolling)
• Huntersville, North Carolina — Huntersville, North Carolina, United States (enrolling)
• Cincinnati, Ohio — Cincinnati, Ohio, United States (enrolling)
• Dublin — Dublin, Ohio, United States (enrolling)
• Abington, Pennsylvania — Abington, Pennsylvania, United States (enrolling)
• Willow Grove, Pennsylvania — Willow Grove, Pennsylvania, United States (enrolling)
• North Charleston, South Carolina — North Charleston, South Carolina, United States (enrolling)
• Austin, Texas — Austin, Texas, United States (enrolling)
• El Paso, Texas — El Paso, Texas, United States (enrolling)
• Toronto — Toronto, Ontario, Canada (enrolling)
• Bologna — Bologna, BO, Italy (enrolling)
• Verona — Verona, VR, Italy (enrolling)
• Móstoles, Madrid — Móstoles, Madrid, Spain (enrolling)
• Álava, Spain — Álava, Spain (enrolling)

Full record on ClinicalTrials.gov

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