A Phase 2, Long-term Extension Study of the Safety and Efficacy of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia Who Completed a Sponsored ORX750 Clinical Trial
Centessa Pharmaceuticals (UK) Limited
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
- Age range
- 18–65 years
- Sex
- All
- 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
Interventions
- DrugORX750
Oral ORX750
- DrugORX750
Oral ORX750
- DrugORX750
Oral ORX750
Locations (24)
- Auburn, alabamaAuburn, Alabama
- Santa Ana, CaliforniaSanta Ana, California
- Miami, FloridaMiami, Florida
- Orlando, FloridaOrlando, Florida
- Winter Park, FLWinter Park, Florida
- Stockbridge, GAAtlanta, Georgia