30
Participants
Start Date
June 28, 2021
Primary Completion Date
October 6, 2023
Study Completion Date
October 31, 2024
Pitolisant Oral Tablet
"Pitolisant 4.45 mg tablets: white, round, plain, biconvex film-coated tablet, 3.7 mm in diameter. Each tablet contains 5 mg of pitolisant hydrochloride equivalent to 4.45 mg of pitolisant.~Pitolisant 17.8 mg tablets: white, round, plain, biconvex film-coated tablet, 7.5 mm in diameter. Each tablet contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant."
Placebo oral tablet
Matching placebo tablets will be provided for each strength of active pitolisant film-coated tablets.
University of Rochester Medical Center, Rochester
University of Pennsylvania, Philadelphia
Kennedy Krieger Institute Center for Genetic Muscle Disorders, Baltimore
Wake Forest, Winston-Salem
University of North Carolina, Chapel Hill
Rare Disease Research, Atlanta
University of South Florida, Tampa
Indiana University, Indianapolis
University of Minnesota, Minneapolis
University of Colorado School of Medicine, Aurora
UCI Center for Clinical Research, Irvine
The Ottawa Hospital, Ottawa
Hôpital de Chicoutimi, Chicoutimi
Harmony Biosciences Management, Inc.
INDUSTRY