A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Open Label Long Term Extension Study
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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) |
|
Recruiting Locations
Site Number 1
Huntersville 4472370, North Carolina 4482348 28070
Huntersville 4472370, North Carolina 4482348 28070
More Details
- NCT ID
- NCT07096674
- Status
- Recruiting
- Sponsor
- Centessa Pharmaceuticals (UK) Limited