RECRUITING

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

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).

Study Overview

Study Details

Study overview

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).

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

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

Condition
Narcolepsy Type 1
Intervention / Treatment

-

Contacts and Locations

Huntersville

Site Number 1, Huntersville, North Carolina, United States, 28070

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Centessa Pharmaceuticals (UK) Limited,

Study Record Dates

2026-04-30