A Phase 2, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 2 mg and 4 mg SUVN-G3031 Compared to Placebo in Patients

Date Added
April 27th, 2022
PRO Number
Pro00116906
Researcher
Thomas Uhde

List of Studies


Keywords
Sleep Disorders
Summary

The study is designed to look at the usefulness and safety of SUVN-G3031 or placebo for the treatment of excessive daytime sleepiness. Study staff nor the participants will know if they are receiving a study drug or placebo. Participants will be male or female subjects 18-50 years old with a diagnosis of narcolepsy. The study will last approximately 3 to 7 weeks with 5 visits for an individual subject. Study drug will be administered as a pill.

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

A Study to Assess the Long-term Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects with Narcolepsy

Date Added
February 14th, 2022
PRO Number
Pro00116774
Researcher
Thomas Uhde

List of Studies


Keywords
Sleep Disorders
Summary

The study is designed to look at the usefulness and safety of AXS-12 or placebo for the treatment of Narcolepsy. The open-label treatment period is 24 weeks, which will be followed by a double-blind treatment period of 4 weeks, for a total of up to 28 weeks with 13 visits. Narcolepsy is a chronic sleep disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep. Study staff nor the participants will know if they are receiving a study drug or placebo. Participants will be male or female subjects 15-75 years old with a diagnosis of narcolepsy. Study drug will be administered as a pill.

Institution
MUSC
Recruitment Contact
Richard Simmons
8437927439
simmr@musc.edu

A Phase 4 Multicenter, Open-label, Single-arm Study of Safety, Tolerability, Effectiveness and Treatment Optimization in Participants Switching From Xyrem to XYWAV for the Treatment of Narcolepsy

Date Added
January 24th, 2022
PRO Number
Pro00110337
Researcher
Thomas Uhde

List of Studies


Keywords
Sleep Disorders
Summary

The study is designed to look at the usefulness and safety of switching patients from Xyrem to XYWAV in the treatment of narcolepsy. Narcolepsy is a chronic sleep disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep. Participants will be male or female subjects 18 to 80 years old. An estimated total of 100 participants are expected to be enrolled in this study. The study treatment period from screening to follow-up will last approximately 17 weeks.

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

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects with Narcolepsy

Date Added
December 13th, 2021
PRO Number
Pro00113095
Researcher
Thomas Uhde

List of Studies


Keywords
Sleep Disorders
Summary

The study is designed to look at the usefulness and safety of AXS-12 or placebo for the treatment of Narcolepsy. Narcolepsy is a chronic sleep disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep. Study staff nor the participants will know if they are receiving a study drug or placebo. Participants will be male or female subjects 15-75 years old with a diagnosis of narcolepsy. The study will last approximately 28 weeks with 8 visits for an individual subject. Study drug will be administered as a pill.

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

Suvorexant for insomnia in treatment seeking adults with alcohol use disorder (AUD)

Date Added
November 3rd, 2020
PRO Number
Pro00102366
Researcher
Thomas Uhde

List of Studies


Keywords
Alcohol, Sleep Disorders
Summary

The purpose of this study is to evaluate the safety and effectiveness of suvorexant versus placebo (an inactive substance) on individuals with alcohol use disorder experiencing insomnia during abstinence. Participants will be 18 years of age or older. Twenty-four participants will have a 50:50 chance to the study drug or placebo. The study participation will last approximately six weeks, requiring four visits.

Institution
MUSC
Recruitment Contact
Richard Simmons
8437927439
simmr@MUSC.edu

Development of the Sleep Research Data Repository (SRDR)

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

List of Studies


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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