50
Participants
Start Date
December 28, 2022
Primary Completion Date
February 28, 2024
Study Completion Date
March 21, 2024
Serdexmethylphenidate
Participants randomized to active drug will receive their optimized dose according to a dosing regimen set by randomization at the start of the OLTP. The 4 possible oral SDX doses are 80, 160, 240, or 320 mg/day. The optimal SDX dose will be determined during the 5-week OLTP preceding the 2-week DBWP.
Placebo
Participants randomized to placebo will receive matching placebo capsules to the optimized dose established at the end of the OLTP, according to a dosing regimen set by randomization at the start of the OLTP.
Thomas Jefferson University, Philadelphia
Brian Abaluck, LLC, Malvern
Mid-Atlantic Epilepsy and Sleep Center - Bethesda, Bethesda
TPMG Clinical Research - Williamsburg, Williamsburg
Clinical Research of Gastonia (CRG), Gastonia
Bogan Sleep Consultants, Columbia
Medical University Of South Carolina (MUSC) - Institute Of Psychiatry (IOP), Charleston
Clinical Research Institute - Stockbridge, Stockbridge
Global Research Associates, Atlanta
Neurotrials Research, Inc, Atlanta
Clinical Site Partners, LLC - Winter Park, Winter Park
New Generation of Medical Trials, Hialeah
Angels Clinical Research, Miami
Ivetmar Medical Group, Miami
Somnology Research Associates, Miami
Clinical Trial Services, Corp, Miami
Pasadena Center for Medical Research, St. Petersburg
Saint Francis Sleep Allergy and Lung Institute LLC, Clearwater
Sleep Disorders Center Of Alabama, Birmingham
Lakeview Clinical Research, Guntersville
Amr Daphne, Daphne
Ohio Sleep Medicine Institute, Dublin
Intrepid Research, Cincinnati
Clinical Neurophysiology Services PC, Sterling Heights
Henry Ford Health - Columbus, Novi
Western Michigan University Homer Stryker Md School of Medicine, Kalamazoo
Clayton Sleep Institute, Llc, St Louis
The University of Kansas Medical Center Research Institution Inc., Kansas City
University of Missouri School Of Medicine, Columbia
Barrett Clinic, La Vista
Dfw Clinical Research Associates, Fort Worth
Houston Clinical Research Associates, Houston
Sleep Therapy & Research Center, San Antonio
Futuresearch Trials Of Neurology, Austin
Delta Waves, Inc., Colorado Springs
SOCAL Clinical Research, Huntington Beach
SDS Clinical Trials, Inc, Santa Ana
Stanford University, Redwood City
Sleep Medicine Specialists of California, San Ramon
Neurocare, Inc., Newton
Global Medical Institutes LLC- Princeton Medical Institute, Lawrence
Lead Sponsor
Rho, Inc.
INDUSTRY
Zevra Therapeutics
INDUSTRY