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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Auburn, alabama
Auburn, Alabama, United States
Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: Up to day 70
Abnormal Laboratory Tests
Number of Participants With Abnormal Changes From Baseline in Laboratory Tests
Time frame: Up to day 70
Abnormal Vital Signs
Number of Participants With Abnormal Change From Baseline in Vital Signs
Time frame: Up to day 70
Abnormal ECG
Number of Participants With Abnormal Change From Baseline in Electrocardiograms (ECG)
Time frame: Up to day 70
Suicidal Ideation or Behavior
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to day 70
Cmax
Cmax: Maximum Observed Plasma Concentration for ORX750
Time frame: Up to day 63
Tmax
Tmax: Time of Maximum Concentration for ORX750
Time frame: Up to day 63
AUClast
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX750
Time frame: Up to day 63
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Santa Ana, California
Santa Ana, California, United States
RECRUITINGMiami, Florida
Miami, Florida, United States
RECRUITINGOrlando, Florida
Orlando, Florida, United States
RECRUITINGWinter Park, FL
Winter Park, Florida, United States
RECRUITINGStockbridge, GA
Atlanta, Georgia, United States
RECRUITINGAtlanta, Georgia
Atlanta, Georgia, United States
RECRUITINGSterling Heights, Michigan
Sterling Heights, Michigan, United States
RECRUITINGHendersen, Navada
Henderson, Nevada, United States
RECRUITINGHenderson, Nevada
Henderson, Nevada, United States
RECRUITING...and 14 more locations
Cmax,ss
Cmax,ss: Maximum Observed Concentration at Steady State for ORX750
Time frame: Up to day 63
AUCτ
AUCτ: Area Under the Concentration-time Curve During a Dosing Interval at Steady State for ORX750
Time frame: Up to day 63
Maintenance of Wakefulness Test
Change From Baseline in Mean sleep latency (average of the first 4 trials) in the Maintenance of Wakefulness Test (MWT)
Time frame: Up to day 63
Epworth Sleepiness Scale
Change From Baseline in Epworth Sleepiness Scale (ESS)
Time frame: Up to day 63