A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants with Narcolepsy Followed by an Open-label Extension

Date Added
August 28th, 2026
PRO Number
Pro00152132
Researcher
Thomas Uhde

List of Studies


Keywords
Drug Studies, Sleep Disorders
Summary

The 16-week main phase of the study is designed to assess the efficacy and safety of the once daily pitolisant, administered orally upon wakening, in comparison to a placebo. This study includes overnight sleep studies. The effects of HBS-301 on excessive daytime sleepiness, fatigue, and cataplexy (NT1 population only) will be examined.

After the main phase period, there is an option to be in the second part of the study, which will span 1 year. During this period, subjects will receive open label of the active drug, HBS-301.

Institution
MUSC
Recruitment Contact
Brooke Cameron
(843) 876-9262
camerobr@musc.edu

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants with Idiopathic Hypersomnia (IH) Followed by an Open-label Extension

Date Added
July 31st, 2026
PRO Number
Pro00149917
Researcher
Thomas Uhde

List of Studies


Keywords
Drug Studies, Sleep Disorders
Summary

The 16-week main phase of the study is designed to assess the efficacy and safety of the once daily pitolisant, administered orally upon wakening, in comparison to a placebo. The effects of HBS-301 on excessive daytime sleepiness, sleep inertia (slow to wake up/groggy), and fatigue will be examined.

After the main phase period, there is an option to be in the second part of the study, which will span 1 year. During this period, subjects will receive open label of the active drug, HBS-301.

Institution
MUSC
Recruitment Contact
Brooke Cameron
(843) 876-9262
camerobr@musc.edu

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of E2086 in Adults with Narcolepsy

Date Added
June 24th, 2026
PRO Number
Pro00150132
Researcher
Thomas Uhde

List of Studies


Keywords
Drug Studies, Sleep Disorders
Summary

The 18 week study is designed to assess the efficacy and safety of the once daily E2086, in narcolepsy Type 1 and Type 2. Administered upon wakening, 3 different doses will be compared to a placebo. This study requires overnight sleep studies. The effects of E2086 on mean sleep latencies will be examined.

Institution
MUSC
Recruitment Contact
Brooke Cameron
(843) 876-9262
camerobr@musc.edu

An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients with Schizophrenia, Bipolar Disorder, or Autism Spectrum Disorder

Date Added
August 21st, 2025
PRO Number
Pro00140167
Researcher
Thomas Uhde

List of Studies


Keywords
Autism
Summary

Currently, there are no FDA-approved medications for the treatment of irritability associated with Autism Spectrum Disorder (ASD). This study is designed to look at the usefulness and safety of lumateperone (CAPLYTA) for the treatment of irritability associated with ASD among pediatric participants between the ages of 5 to 17 years. The study will last approximately 26 weeks and the participants will receive the study drug, lumateperone.

Institution
MUSC
Recruitment Contact
Jelissa Suarez
843-876-9262
suarezj@musc.edu

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated with Autism Spectrum Disorder in Pediatric Patients 5 to 17 years of Age

Date Added
March 25th, 2025
PRO Number
Pro00142895
Researcher
Thomas Uhde

List of Studies


Keywords
Autism
Summary

Currently, there are no FDA-approved medications for the treatment of irritability associated with Autism Spectrum Disorder (ASD). This study is designed to look at the efficacy and safety of lumateperone (CAPLYTA) for the treatment of irritability associated with ASD among pediatric participants between the ages of 5 to 17 years.

It is a 6-week study, and the study drug will be compared to a placebo. Following this study, there will be an opportunity to participate in an open-label extension study where all participants will be on the active study medicine.

Institution
MUSC
Recruitment Contact
Jelissa Suarez
843-876-9262
suarezj@musc.edu

A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated with Shift Work Disorder

Date Added
November 1st, 2024
PRO Number
Pro00138871
Researcher
Thomas Uhde

List of Studies


Keywords
Sleep Disorders
Summary

The study is designed to look at the usefulness and safety of Solriamfetol (versus placebo) for the treatment of excessive sleepiness associated with shift work disorder (SWD). Study staff nor the participants will know if they are receiving a study drug or placebo. Participants will be male or female subjects 18-65 years old with a diagnosis of SWD. The study will last approximately 17 weeks, with 6 in-person visits and 8 remote visits for each participant.

Institution
MUSC
Recruitment Contact
Jelissa Suarez
843-876-9262
suarezj@musc.edu



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