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.
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.
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.
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.
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.
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.