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A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
Scottsdale/Phoenix, Ariz.
The purpose of this study istoevaluate the effectiveness and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.
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A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects With Narcolepsy (REST-ON)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine whether FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
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A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [(R)-2-amino-3 Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea
Scottsdale/Phoenix, Ariz.
This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.
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A Randomized, Placebo-Controlled, Double blind, Crossover Study of Oral BTD-001 in Adults with Idiopathic Hypersomnia (ARISE2)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the safety, tolerability and effectiveness of BTD-001 in subjects with idiopathic hypersomnia (IH) as reflected by changes in mental fogginess, sleep, functional, and quality-of-life measures.
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A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-Amino-3-Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy
Scottsdale/Phoenix, Ariz.
The purpose of this study is to assess the safety and effectiveness of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.
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A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep Apnea (OSA) (OSA)
Scottsdale/Phoenix, Ariz.
This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
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An Open Label Expanded Access Program Intended to Provide Treatment With HBS-101 (Pitolisant) to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy
Jacksonville, Fla.,
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to provide access to treatment with pitolisant while a U.S. New Drug Application (NDA) is being prepared and submitted for review for marketing approval. This program will be open to adult patients in the U.S. with Excessive Daytime Sleepiness (EDS) associated with narcolepsy, with or without cataplexy. Pitolisant will be made available through treating physicians participating in the program.
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Can a Sleep Health ‘App’ Help First-Time Users of Positive Airway Pressure Therapy for Sleep Apnea
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to test the usefullness and initial effectiveness of an mHealth smartphone app to increase use of positive airway pressure (PAP) therapy in obstructive sleep apnea (OSA) patients treated at the Mayo Clinic Arizona Center for Sleep Medicine.
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The Significance of the Home Sleep Environment: The Effect of Dogs in the Bedroom on Human Sleep
Scottsdale/Phoenix, Ariz.
The purpose of this study is to assess with objective data if the presence of a dog in the bedroom disturbs their human's sleep.
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