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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

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

Auburn, alabama
Auburn, Alabama 36832

Santa Ana, California
Santa Ana, California 92705

Miami, Florida
Miami, Florida 33176

Orlando, Florida
Orlando, Florida 32807

Winter Park, FL
Winter Park, Florida 32789

Stockbridge, GA
Atlanta, Georgia 30281

Atlanta, Georgia
Atlanta, Georgia 30328

Sterling Heights, Michigan
Sterling Heights, Michigan 48314

Hendersen, Navada
Henderson, Nevada 89052

Henderson, Nevada
Henderson, Nevada 89052

Denver, North Carolina
Denver, North Carolina 28037

Huntersville, North Carolina
Huntersville, North Carolina 28070

Cincinnati, Ohio
Cincinnati, Ohio 45245

Dublin
Dublin, Ohio 43017

Abington, Pennsylvania
Abington, Pennsylvania 19046

Willow Grove, Pennsylvania
Willow Grove, Pennsylvania 19090

North Charleston, South Carolina
North Charleston, South Carolina 29406-9196

Austin, Texas
Austin, Texas 30328

El Paso, Texas
El Paso, Texas 79912

More Details

Status
Recruiting
Sponsor
Centessa Pharmaceuticals (UK) Limited

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.