A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ORX750, ORX750, ORX750.
- Who it may be relevant to
- Registry conditions: Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, Italy, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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).
Interventions
- Drug ORX750
Oral ORX750 - Drug ORX750
Oral ORX750 - Drug ORX750
Oral ORX750
Primary outcome measures
- Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs [Time frame: Up to day 70]
- Abnormal Laboratory Tests [Time frame: Up to day 70]
- Abnormal Vital Signs [Time frame: Up to day 70]
- Abnormal ECG [Time frame: Up to day 70]
- Suicidal Ideation or Behavior [Time frame: Up to day 70]
Secondary outcome measures (7)
- Cmax [Time frame: Up to day 63]
- Tmax [Time frame: Up to day 63]
- AUClast [Time frame: Up to day 63]
- Cmax,ss [Time frame: Up to day 63]
- AUCτ [Time frame: Up to day 63]
- Maintenance of Wakefulness Test [Time frame: Up to day 63]
- Epworth Sleepiness Scale [Time frame: Up to day 63]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 19 centers
- Auburn, alabama — Auburn
- Santa Ana, California — Santa Ana
- Miami, Florida — Miami
- Orlando, Florida — Orlando
- Winter Park, FL — Winter Park
- Stockbridge, GA — Atlanta
- Atlanta, Georgia — Atlanta
- Sterling Heights, Michigan — Sterling Heights
- … and 11 more centers
Italy · 2 centers
- Bologna — Bologna
- Verona — Verona
Spain · 2 centers
- Móstoles, Madrid — Móstoles
- Álava, Spain — Álava
Canada · 1 center
- Toronto — Toronto
Identifiers
NCT: NCT07096674 · ORX750-202