RecruitingPhase 2

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

United States90 participantsStarted 2025-08-12

Plain-language 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).

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

Timeframe: Up to day 70

Abnormal Laboratory Tests

Timeframe: Up to day 70

Abnormal Vital Signs

Timeframe: Up to day 70

Abnormal ECG

Timeframe: Up to day 70

Suicidal Ideation or Behavior

Timeframe: Up to day 70

Trial details

NCT IDNCT07096674

SponsorCentessa Pharmaceuticals (UK) Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-30

Contact for this trial

Orexin Centessa Program Lead

617-468-5770 ORX750-LTE@centessa.com

View on ClinicalTrials.gov More Narcolepsy Type 1 trials