RecruitingPhase 2NCT07096674

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


Sponsor

Centessa Pharmaceuticals (UK) Limited

Enrollment

90 participants

Start Date

Aug 12, 2025

Study Type

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

Min Age: 18 YearsMax Age: 65 Years

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

DRUGORX750

Oral ORX750

DRUGORX750

Oral ORX750

DRUGORX750

Oral ORX750


Locations(14)

Auburn, alabama

Auburn, Alabama, United States

Santa Ana, California

Santa Ana, California, United States

Miami, Florida

Miami, Florida, United States

Atlanta, Georgia

Atlanta, Georgia, United States

Atlanta, Georgia

Atlanta, Georgia, United States

Sterling Heights, Michigan

Sterling Heights, Michigan, United States

Hendersen, Navada

Henderson, Nevada, United States

Denver, North Carolina

Denver, North Carolina, United States

Huntersville, North Carolina

Huntersville, North Carolina, United States

Cincinnati, Ohio

Cincinnati, Ohio, United States

Willow Grove, Pennsylvania

Willow Grove, Pennsylvania, United States

North Charleston, South Carolina

North Charleston, South Carolina, United States

Austin, Texas

Austin, Texas, United States

El Paso, Texas

El Paso, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07096674


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