RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2025-08-12
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07096674

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Is willing and able to adhere to additional protocol requirements
  1. * Development of any new disease/disorder that in the opinion of the investigator would make the participant unable to continue the study
  2. * Unable to refrain from excluded medications, including those used for treatment of narcolepsy or idiopathic hypersomnia

Contacts and Locations

Study Contact

Orexin Centessa Program Lead
CONTACT
617-468-5770
ORX750-LTE@centessa.com

Study Locations (Sites)

Site Number 1
Huntersville, North Carolina, 28070
United States

Collaborators and Investigators

Sponsor: Centessa Pharmaceuticals (UK) Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-12
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2025-08-12
Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

  • NT1
  • NT2
  • IH
  • Narcolepsy
  • Narcolepsy Type 1
  • Narcolepsy Type 2
  • Idiopathic Hypersomnia
  • Excessive Daytime Sleepiness
  • Orexin Receptor 2 agonist

Additional Relevant MeSH Terms

  • Narcolepsy Type 1
  • Narcolepsy Type 2
  • Idiopathic Hypersomnia