Harmony Biosciences Management, Inc.

This study looks at the long-term safety and effectiveness of pitolisant in adults with idiopathic hypersomnia, a condition causing excessive daytime sleepiness. Participants had already completed a previous study. The goal is to see if pitolisant remains safe and helps control s…

This phase 2 trial tests whether pitolisant, a wake-promoting drug, can reduce excessive daytime sleepiness in adults aged 18 to 65 with myotonic dystrophy type 1. Participants receive either pitolisant or a placebo for a period, and researchers measure changes in sleepiness, fat…

This study tested a cannabidiol (CBD) gel, called ZYN002, applied to the skin in 215 children, teens, and young adults with Fragile X syndrome. The goal was to see if it could improve behavioral symptoms like irritability and social withdrawal. Participants received either the CB…

This phase 2 study tested whether pitolisant, a drug that promotes wakefulness, can safely reduce excessive daytime sleepiness in people with Prader-Willi syndrome. The trial enrolled 65 participants aged 6 to 65 and compared pitolisant to a placebo over 11 weeks, followed by an …

This study tested a gel called ZYN002, applied to the skin, in 20 children and teens (ages 4-17) with 22q11.2 deletion syndrome. The main goal was to see if the gel is safe and tolerable over 38 weeks. Researchers also looked at whether it could improve behavior and other symptom…

This early-phase study tested a new slow-release form of pitolisant (HBS-201) in 46 adults with narcolepsy. The goal was to see if starting at a full dose is tolerable. Participants took the drug for 14 days, and researchers tracked side effects and dropouts.

This study looked at how a gel called ZYN002 affects the way the body processes other drugs. Twenty-nine healthy adults took ZYN002 along with several common medications to see if there were any changes in drug levels. The goal was to understand potential interactions so doctors …