A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2

Date Added
October 1st, 2026
PRO Number
Pro00150148
Researcher
Thomas Uhde

List of Studies


Keywords
Drug Studies, Sleep Disorders
Summary

The 12 week study is designed to assess the efficacy and safety of the twice daily ALKS2680, in narcolepsy Type 2. Administered upon wakening and a second time 3-5 hours later, 3 different doses will be compared to a placebo. The effects of ALKS2680 on excessive daytime sleepiness and sleep quality will be examined during overnight and daytime sleep studies.

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

Date Added
October 1st, 2026
PRO Number
Pro00150142
Researcher
Thomas Uhde

List of Studies


Keywords
Drug Studies, Sleep Disorders
Summary

The 12 week study is designed to assess the efficacy and safety of the twice daily ALKS2680, in narcolepsy Type 1. Administered upon wakening and a second time 5-7 hours later, 2 different doses (6mg and 10mg) will be compared to a placebo. The effects of ALKS2680 on excessive daytime sleepiness and sleep quality will be examined during overnight and daytime sleep studies.

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 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

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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