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 Save

Date Added
November 13th, 2018
PRO Number
Pro00082995
Researcher
Thomas Uhde

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Keywords
Sleep Disorders
Summary

The study is designed to look at the usefulness and safety of an oxybate mixed-salts oral solution or placebo for treatment of Idiopathic Hypersomnia. Idiopathic Hypersomnia (IH) is a sleep disorder in which a person is excessively sleepy during the day and has great difficulty being awakened from sleep. Study staff nor participants will know if they are receiving study drug or placebo. Participants will be male or female subjects 18-70 years old with a diagnosis of Idiopathic Hypersomnia (IH) within the last five years, and not due to other medical conditions such as Narcolepsy, restless leg syndrome, and uncontrolled hypothyroidism. A minimum of 140 study subjects will be randomized across all sites with 72 randomized to the study drug and 72 to the placebo drug. The study treatment period from screening to follow-up will last approximately 42 weeks, requiring nine visits. An overnight stay might be required to confirm the diagnosis of IH.

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

Odor Disturbances: Clinical Care Registry Save

Date Added
September 26th, 2018
PRO Number
Pro00080333
Researcher
Thomas Uhde

List of Studies


Profiles_link
Keywords
ADD/ADHD, Adolescents, Aging, Allergy, Alzheimers, Anxiety, Asthma, Autism, Autoimmune disease, Central Nervous System, Chronic Fatigue, Depression, Environmental Factors, Fibromyalgia, Inflammation, Memory Loss, Nervous System, Parkinsons, Psychiatry
Summary

Candidates for this study may or may not report disturbances in odor perception as their primary reason for seeking treatment at MUSC. This study is designed to collect long term, observational data from patients who are being treated with routine clinical care in health clinics at MUSC. Data from clinical questionnaires will be de-identified and stored in a database.

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

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

List of Studies


Profiles_link
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

List of Studies


Profiles_link
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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