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Clinical trial Recruiting at 24 sites Phase 2 Interventional Ages 18 to 65

Long-term ORX750 treatment for people with narcolepsy or idiopathic hypersomnia

Official title: 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

Run by Centessa Pharmaceuticals (UK) Limited · NCT07096674 · Data updated 2026-11-12

This open-label extension will try continued ORX750 treatment in people with narcolepsy or idiopathic hypersomnia who completed the earlier ORX750 parent study.

More Idiopathic Hypersomnia trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment90 (estimated)
SponsorCentessa Pharmaceuticals (UK) Limited
Industry-sponsored
Locations24 sites (Auburn, Alabama and 23 other locations)
StatusRecruiting
StartedAugust 12, 2025
Main results expectedApril 30, 2026
Study endsApril 30, 2026
Registry record updatedApril 16, 2026
Trial IDNCT07096674 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are people with narcolepsy type 1 or 2 or idiopathic hypersomnia who completed the full treatment period of the parent ORX750-0201 (CRYSTAL-1) study and can follow the protocol.

Probably not a fit

People who did not finish the parent study, who develop new medical conditions that prevent continued participation, or who cannot stop excluded medications are unlikely to join or benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This long-term extension enrolls participants who completed the parent ORX750-0201 (CRYSTAL-1) study to receive open-label ORX750 with ongoing monitoring. The main focus is collecting long-term safety and tolerability data, with additional measures of symptomatic benefit over time. Participants will attend regular clinic visits for examinations, adverse event monitoring, and efficacy assessments. New medical conditions or use of excluded medications may disqualify continued participation.

Why it matters

Potential benefit: If successful, long-term ORX750 could offer a well-tolerated treatment option that reduces daytime sleepiness and other symptoms for people with narcolepsy or idiopathic hypersomnia.

How similar studies have gone: Earlier-phase studies of ORX750 and other orexin-targeting drugs have shown promising short-term effects on wakefulness, but long-term outcomes remain limited.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Auburn, alabama
    Auburn, Alabama, United States     Recruiting
  • Santa Ana, California
    Santa Ana, California, United States     Recruiting
  • Miami, Florida
    Miami, Florida, United States     Recruiting
  • Orlando, Florida
    Orlando, Florida, United States     Recruiting
  • Winter Park, FL
    Winter Park, Florida, United States     Recruiting
  • Stockbridge, GA
    Atlanta, Georgia, United States     Recruiting
Show 18 more locations
  • Atlanta, Georgia
    Atlanta, Georgia, United States     Recruiting
  • Sterling Heights, Michigan
    Sterling Heights, Michigan, United States     Recruiting
  • Hendersen, Navada
    Henderson, Nevada, United States     Recruiting
  • Henderson, Nevada
    Henderson, Nevada, United States     Recruiting
  • Denver, North Carolina
    Denver, North Carolina, United States     Recruiting
  • Huntersville, North Carolina
    Huntersville, North Carolina, United States     Recruiting
  • Cincinnati, Ohio
    Cincinnati, Ohio, United States     Recruiting
  • Dublin
    Dublin, Ohio, United States     Recruiting
  • Abington, Pennsylvania
    Abington, Pennsylvania, United States     Recruiting
  • Willow Grove, Pennsylvania
    Willow Grove, Pennsylvania, United States     Recruiting
  • North Charleston, South Carolina
    North Charleston, South Carolina, United States     Recruiting
  • Austin, Texas
    Austin, Texas, United States     Recruiting
  • El Paso, Texas
    El Paso, Texas, United States     Recruiting
  • Toronto
    Toronto, Ontario, Canada     Recruiting
  • Bologna
    Bologna, Bo, Italy     Recruiting
  • Verona
    Verona, Vr, Italy     Recruiting
  • Móstoles, Madrid
    Móstoles, Madrid, Spain     Recruiting
  • Álava, Spain
    Álava, Spain     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Narcolepsy Type 1 15Narcolepsy Type 2 7Idiopathic Hypersomnia 16Centessa Pharmaceuticals (UK) Limited 3
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.