A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentessa Pharmaceuticals (UK) Limited
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ORX750
- ORX750
- ORX750
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov