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A Study to Analyze Concept Elicitation and Content Validation for Narcolepsy Type 2 and Idiopathic Hypersomnia
Scottsdale/Phoenix, AZ; Rochester, MN
This study will involve in-depth, qualitative interviews with adults who have a diagnosis of NT2 (N = 15), who meet the agreed inclusion/exclusion criteria. All interviews will be undertaken in the United States (US). Each participant will take part in two interviews; each interview will last approximately 75 minutes, and interviews will be completed within seven days of each other. The interviews will be semi-structured, using a discussion guide, and all will be conducted by a trained interviewer. The interviews will be conducted via telephone, or face-to-face using a web-assisted platform.
Interview 1 will consist of a concept elicitation (CE) ...
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A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety and efficacy of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
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A Study of Childhood Onset Narcolepsy
Rochester, MN
The purpose of this study is to evaluate the clinical presentations, polysomnographic features, treatment patterns of all children with narcolepsy in multiple CTSA (Clinical and Translational Science Award) centers.Comparison between recent cases (2009-June 30, 2012) and old cases (prior to 2009) will be performed. To assess the role of infection and other triggering factors in early onset Narcolepsy.
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A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety and effectiveness of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
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A Study to Provide Treatment with Pitolisant to Adult Patients in the U.S. with Excessive Daytime Sleepiness Associated with Narcolepsy with or without Cataplexy
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
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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Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
Scottsdale/Phoenix, AZ
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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Long-term Outcomes of Secondary Narcolepsy in Childhood and Adolescence
Rochester, MN
The purpose of this study is to document the long-term outcomes of secondary (symptomatic) narcolepsy in the pediatric patient population at the Mayo Clinic using chart review and mailed questionnaire.
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A Study to Evaluate Safety, and Efficacy of SUVN-G3031 in Patients With Narcolepsy With and Without Cataplexy
Scottsdale/Phoenix, AZ
Primary objective: To evaluate the effectiveness of SUVN-G3031 compared with placebo as measured by an improvement in the Maintenance of Wakefulness Test (MWT) score. Secondary objectives: To evaluate the effectiveness of SUVN-G3031 compared with placebo as measured by subjective measures including an improvement in the Clinical Global Impression of Severity (CGI-S) score related to excessive daytime sleepiness (EDS) and the change in total Epworth Sleepiness Scale (ESS) score.
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A Study of the Safety and Effectiveness of JZP-110 in the Treatment of Excessive Sleepiness in Patients with Narcolepsy
Scottsdale/Phoenix, AZ
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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Does Narcolepsy/Idiopathic Hypersomnia and Their Treatment(s) Alter Blood Pressure and Cognition
Scottsdale/Phoenix, AZ; Rochester, MN
The objectives of this study are to demonstrate that patients with CNS hypersomnias exhibit cardiovascular and cognitive disturbances, and to demonstrate that CNS medications medications impact these cardiovascular and cognitive disturbances.
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A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA
Scottsdale/Phoenix, AZ
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.