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 2, Placebo-Controlled, Double-Blind, Randomized Withdrawal Study to Determine the Safety and Efficacy of Oral SDX in Patients with Idiopathic Hypersomnia (IH)

Date Added
April 5th, 2023
PRO Number
Pro00127155
Researcher
Thomas Uhde

List of Studies


Keywords
Sleep Disorders
Summary

The current study will investigate the safety, efficacy and pharmacokinetics of serdexmethylphenidate (SDX) compared to placebo in subjects with Idiopathic Hypersomnia (IH). The study may inform about the best dosing regimen, optimal dose range, duration of treatment, and secondary endpoints for a future Phase 3 study.

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



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