A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of Pitolisant in Adult Patients with Idiopathic Hypersomnia

Date Added
November 16th, 2022
PRO Number
Pro00121341
Researcher
Thomas Uhde

List of Studies


Keywords
Sleep Disorders
Summary

The study is designed to look at the usefulness and safety of pitolisant or placebo for the 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. The study staff nor the participants will know if they are receiving the study drug or a placebo. Participants will be male or female 18 or older with a diagnosis of Idiopathic Hypersomnia (IH). The study treatment period from screening to follow-up will last approximately 16 weeks, requiring five visits and seven telephone calls.

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

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 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

Odor Disturbances: Clinical Care Registry

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

List of Studies


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



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