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

Last updated: April 15, 2026
Sponsor: Centessa Pharmaceuticals (UK) Limited
Overall Status: Active - Recruiting

Phase

2

Condition

Sleep Disorders

Narcolepsy

Idiopathic Hypersomnia

Treatment

ORX750

Clinical Study ID

NCT07096674
ORX750-202
  • Ages 18-65
  • All Genders

Study 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

Inclusion Criteria:

  • Diagnosis of narcolepsy (NT1 or NT2) or IH who was eligible for and completed thefull treatment period in the eligible parent study ORX750-0201 (CRYSTAL-1)

  • Is willing and able to adhere to additional protocol requirements

Exclusion

Exclusion Criteria:

  • Development of any new disease/disorder that in the opinion of the investigatorwould make the participant unable to continue the study

  • Unable to refrain from excluded medications, including those used for treatment ofnarcolepsy or idiopathic hypersomnia

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: ORX750
Phase: 2
Study Start date:
August 12, 2025
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • Toronto

    Toronto, Ontario M5S 3A3
    Canada

    Active - Recruiting

  • Bologna

    Bologna, BO 40139
    Italy

    Active - Recruiting

  • Verona

    Verona, VR 37134
    Italy

    Active - Recruiting

  • Móstoles, Madrid

    Móstoles, Madrid 28938
    Spain

    Active - Recruiting

  • Álava, Spain

    Álava, 01004
    Spain

    Active - Recruiting

  • Auburn, alabama

    Auburn, Alabama 36832
    United States

    Active - Recruiting

  • Santa Ana, California

    Santa Ana, California 92705
    United States

    Active - Recruiting

  • Miami, Florida

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Orlando, Florida

    Orlando, Florida 32807
    United States

    Active - Recruiting

  • Winter Park, FL

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Atlanta, Georgia

    Atlanta, Georgia 30328
    United States

    Active - Recruiting

  • Stockbridge, GA

    Atlanta, Georgia 30281
    United States

    Active - Recruiting

  • Sterling Heights, Michigan

    Sterling Heights, Michigan 48314
    United States

    Active - Recruiting

  • Hendersen, Navada

    Henderson, Nevada 89052
    United States

    Active - Recruiting

  • Henderson, Nevada

    Henderson, Nevada 89052
    United States

    Active - Recruiting

  • Denver, North Carolina

    Denver, North Carolina 28037
    United States

    Active - Recruiting

  • Huntersville, North Carolina

    Huntersville, North Carolina 28070
    United States

    Active - Recruiting

  • Site Number 1

    Huntersville, North Carolina 28070
    United States

    Active - Recruiting

  • Cincinnati, Ohio

    Cincinnati, Ohio 45245
    United States

    Active - Recruiting

  • Dublin

    Dublin, Ohio 43017
    United States

    Active - Recruiting

  • Abington, Pennsylvania

    Abington, Pennsylvania 19046
    United States

    Active - Recruiting

  • Willow Grove, Pennsylvania

    Willow Grove, Pennsylvania 19090
    United States

    Active - Recruiting

  • North Charleston, South Carolina

    North Charleston, South Carolina 29406-9196
    United States

    Active - Recruiting

  • Austin, Texas

    Austin, Texas 30328
    United States

    Active - Recruiting

  • El Paso, Texas

    El Paso, Texas 79912
    United States

    Active - Recruiting

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