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

Part of paid clinical trials in Auburn, Alabama.

Sponsor
Centessa Pharmaceuticals (UK) Limited
Study ID
NCT07096674
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Idiopathic Hypersomnia
  • Narcolepsy Type 1
  • Narcolepsy Type 2

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Aug 12, 2025
Status verified
Apr 2026
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Narcolepsy Type 1
    Narcolepsy Type 1 (Open Label)
  • Experimental: Narcolepsy Type 2
    Narcolepsy Type 2 (Open Label)
  • Experimental: Idiopathic Hypersomnia
    Idiopathic Hypersomnia (Open Label)

Primary Outcome Measure

Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs [ Time Frame: Up to day 70 ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Auburn, alabamaAuburnAlabama36832-
Santa Ana, CaliforniaSanta AnaCalifornia92705-
Miami, FloridaMiamiFlorida33176-
Orlando, FloridaOrlandoFlorida32807-
Winter Park, FLWinter ParkFlorida32789-
Atlanta, GeorgiaAtlantaGeorgia30328-
Stockbridge, GAAtlantaGeorgia30281-
Sterling Heights, MichiganSterling HeightsMichigan48314-
Hendersen, NavadaHendersonNevada89052-
Henderson, NevadaHendersonNevada89052-
Denver, North CarolinaDenverNorth Carolina28037-
Huntersville, North CarolinaHuntersvilleNorth Carolina28070-
Cincinnati, OhioCincinnatiOhio45245-
DublinDublinOhio43017-
Abington, PennsylvaniaAbingtonPennsylvania19046-
Willow Grove, PennsylvaniaWillow GrovePennsylvania19090-
North Charleston, South CarolinaNorth CharlestonSouth Carolina29406-9196-
Austin, TexasAustinTexas30328-
El Paso, TexasEl PasoTexas79912-

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By research site
Auburn, alabama· Auburn, ALSanta Ana, California· Santa Ana, CAMiami, Florida· Miami, FLOrlando, Florida· Orlando, FLWinter Park, FL· Winter Park, FLAtlanta, Georgia· Atlanta, GA

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