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 Save

Date Added
August 28th, 2018
PRO Number
Pro00077667
Researcher
Thomas Uhde

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Keywords
Sleep Disorders
Summary

The study is designed to assess the efficiency and safety of a once nightly formulation of sodium oxybate for extended-release oral suspension or a placebo for the treatment of excessive daytime sleepiness and cataplexy, sudden and uncontrollable muscle weakness or paralysis, in subjects with narcolepsy. Study staff nor participants will know if they are receiving study drug or placebo. Participants will be male or female subjects 18 years of age or older. A total of 264 study subjects will be randomized across all sites with 132 randomized to the study drug and 132 to the placebo drug. The study treatment period from screening to follow-up will last approximately 17 weeks. Requiring 9 visits with 4 overnight stays.

Institution
MUSC
Recruitment Contact
Richard Simmons
843-792-7439
simmr@MUSC.edu

Development of the Sleep Research Data Repository (SRDR) Save

Date Added
March 1st, 2011
PRO Number
Pro00009339
Researcher
Thomas Uhde

Silhouette
Keywords
Anxiety, Genetics, Mental Health, Psychiatry, Sleep Disorders, Stress Disorders
Summary

The Sleep Research Data Repository (SRDR) aimed to systematically collect, analyze and store for future research sleep and sleep disorders related biological and psychological information. It will include sleep physiological measurements and the results of interviews, questionnaires, and laboratory tests. The SRDR will contain sleep related information obtained from healthy subjects and patients with psychiatric, substance abuse, neurological disorders, or any medical conditions associated with sleep disturbances. SRDR data will be made available to current and future IRB-approved investigators associated with this protocol.

Institution
MUSC
Recruitment Contact
Richard Simmons
843-792-7439
simmr@musc.edu

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