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NCT07096674PHASE2Recruiting

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

Centessa Pharmaceuticals (UK) Limited

Start Date

8/12/2025

Completion Date

4/30/2026

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

Age Range: 18 years to 65 years

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

Interventions

DRUG

ORX750

DRUG

ORX750

DRUG

ORX750

Interested in This Trial?

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Conditions

Narcolepsy Type 1Narcolepsy Type 2Idiopathic Hypersomnia

Locations

Auburn, alabama

Auburn, Alabama 36832

United States

Santa Ana, California

Santa Ana, California 92705

United States

Miami, Florida

Miami, Florida 33176

United States

Orlando, Florida

Orlando, Florida 32807

United States

Winter Park, FL

Winter Park, Florida 32789

United States

Stockbridge, GA

Atlanta, Georgia 30281

United States

Atlanta, Georgia

Atlanta, Georgia 30328

United States

Sterling Heights, Michigan

Sterling Heights, Michigan 48314

United States

Hendersen, Navada

Henderson, Nevada 89052

United States

Henderson, Nevada

Henderson, Nevada 89052

United States

Denver, North Carolina

Denver, North Carolina 28037

United States

Huntersville, North Carolina

Huntersville, North Carolina 28070

United States

Cincinnati, Ohio

Cincinnati, Ohio 45245

United States

Dublin

Dublin, Ohio 43017

United States

Abington, Pennsylvania

Abington, Pennsylvania 19046

United States

Willow Grove, Pennsylvania

Willow Grove, Pennsylvania 19090

United States

North Charleston, South Carolina

North Charleston, South Carolina 29406-9196

United States

Austin, Texas

Austin, Texas 30328

United States

El Paso, Texas

El Paso, Texas 79912

United States

Toronto

Toronto, Ontario M5S 3A3

Canada

Bologna

Bologna, BO 40139

Italy

Verona

Verona, VR 37134

Italy

Móstoles, Madrid

Móstoles, Madrid 28938

Spain

Álava, Spain

Álava, 01004

Spain