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

NCT07096674 · tracked via the Priya Life Science USA tracker

Sponsor

Centessa Pharmaceuticals (UK) Limited

Phase

Phase 2

Started

2025-08-12

Last updated

2026-04-16

Condition(s) studied

Narcolepsy Type 1Narcolepsy Type 2Idiopathic Hypersomnia

Investigational drug(s) / intervention(s)

ORX750ORX750ORX750

ORX750: Oral ORX750

Study summary

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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs — Up to day 70
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Abnormal Laboratory Tests — Up to day 70
Number of Participants With Abnormal Changes From Baseline in Laboratory Tests
Abnormal Vital Signs — Up to day 70
Number of Participants With Abnormal Change From Baseline in Vital Signs
Abnormal ECG — Up to day 70
Number of Participants With Abnormal Change From Baseline in Electrocardiograms (ECG)
Suicidal Ideation or Behavior — Up to day 70
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)

Trial sites (24)

Facility	City	Region	Status
Auburn, alabama	Auburn	Alabama	Recruiting
Santa Ana, California	Santa Ana	California	Recruiting
Miami, Florida	Miami	Florida	Recruiting
Orlando, Florida	Orlando	Florida	Recruiting
Winter Park, FL	Winter Park	Florida	Recruiting
Stockbridge, GA	Atlanta	Georgia	Recruiting
Atlanta, Georgia	Atlanta	Georgia	Recruiting
Sterling Heights, Michigan	Sterling Heights	Michigan	Recruiting
Hendersen, Navada	Henderson	Nevada	Recruiting
Henderson, Nevada	Henderson	Nevada	Recruiting
Denver, North Carolina	Denver	North Carolina	Recruiting
Huntersville, North Carolina	Huntersville	North Carolina	Recruiting
Cincinnati, Ohio	Cincinnati	Ohio	Recruiting
Dublin	Dublin	Ohio	Recruiting
Abington, Pennsylvania	Abington	Pennsylvania	Recruiting
Willow Grove, Pennsylvania	Willow Grove	Pennsylvania	Recruiting
North Charleston, South Carolina	North Charleston	South Carolina	Recruiting
Austin, Texas	Austin	Texas	Recruiting
El Paso, Texas	El Paso	Texas	Recruiting
Toronto	Toronto	Ontario	Recruiting
Bologna	Bologna	BO	Recruiting
Verona	Verona	VR	Recruiting
Móstoles, Madrid	Móstoles	Madrid	Recruiting
Álava, Spain	Álava	Spain	Recruiting

More Centessa Pharmaceuticals (UK) Limited trials in the USA

A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years Recruiting

A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia Recruiting

A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence Recruiting

A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age Recruiting

Other trials for the same condition

A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions Recruiting

A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia Recruiting

A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy) Recruiting

A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia Recruiting

A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07096674 on ClinicalTrials.gov ↗ ← All trials in the USA