Jan 25 2023
INTUNE: A Clinical Study in Adults with Idiopathic Hypersomnia (IH)
h in Clinical Trial
NOW ENROLLING for adults with IH: CLICK HERE
The INTUNE study is being conducted by Harmony Biosciences to evaluate the safety and efficacy of pitolisant, an investigational medication for treating excessive daytime sleepiness (EDS) in people with idiopathic hypersomnia age ≥18 years.
This study is also evaluating the effect of pitolisant on overall symptoms and severity of IH, sleep inertia, cognition, and general sleep-related impairment.
This clinical study consists of a screening period (up to 28 days), an 8-week Open-Label Phase in which all eligible study participants will receive pitolisant, followed by a 4-week Double-Blind Randomized Withdrawal Phase in which study participants and doctors won’t know who is receiving pitolisant or placebo (a tablet that does not contain study drug).
For more information or to find a participating clinical site visit: NCT05156047 or www.intuneihstudy.com
Contact Harmony Biosciences by email at firstname.lastname@example.org