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Clinical Trials in the USA / NCT07096674
Recruiting Phase 2

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)

ORX750 →ORX750 →ORX750 →

ORX750: Oral ORX750

ORX750: Oral ORX750

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
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

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)

FacilityCityRegionStatus
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 to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence Recruiting
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 of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age Recruiting

Other trials for the same condition

A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence Recruiting
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia Recruiting
A Study of TAK-360 in Adults With Idiopathic Hypersomnia Recruiting
A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions Recruiting
A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304) 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