A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
NCT07096674 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-04-16
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).
Conditions
- Narcolepsy Type 1
- Narcolepsy Type 2
- Idiopathic Hypersomnia
Interventions
- DRUG
-
ORX750
Oral ORX750
- DRUG
-
ORX750
Oral ORX750
- DRUG
-
ORX750
Oral ORX750
Sponsors & Collaborators
-
Centessa Pharmaceuticals (UK) Limited
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-12
- Primary Completion
- 2026-04-30
- Completion
- 2026-04-30
- FDA Drug
- Yes
Countries
- United States
- Canada
- Italy
- Spain
Study Locations
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