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

Purpose

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).

Conditions

  • Narcolepsy Type 1
  • Narcolepsy Type 2
  • Idiopathic Hypersomnia

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Open Label Long Term Extension Study
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Narcolepsy Type 1 		Narcolepsy Type 1 (Open Label)
  • Drug: ORX750
    Oral ORX750
Experimental
Narcolepsy Type 2 		Narcolepsy Type 2 (Open Label)
  • Drug: ORX750
    Oral ORX750
Experimental
Idiopathic Hypersomnia 		Idiopathic Hypersomnia (Open Label)
  • Drug: ORX750
    Oral ORX750

Recruiting Locations

Site Number 1
Huntersville 4472370, North Carolina 4482348 28070

More Details

NCT ID
NCT07096674
Status
Recruiting
Sponsor
Centessa Pharmaceuticals (UK) Limited

Study Contact

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

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center