Click image to enlargeSDX is a prodrug of dexmethylphenidate (d-MPH). SDX behaves as a prototypical prodrug that is devoid of pharmacological effects until metabolized to active d-MPH. Central nervous system (CNS) stimulants, including d-MPH products, are being used off-label by patients with IH. The potential advantage of SDX-derived d-MPH is its unique PK profile with rising d-MPH plasma concentrations at approximately 3 hours postdose followed by a broad peak from approximately 8 to 12 hours postdose (without sharp exposure spikes), and a gradual decline after the peak. The optimal dose of SDX will be determined for each participant by titration based on individual tolerability and response during the 5-week SDX-only Open-Label Titration period (OLTP), after which 2/3 of the participants will continue to receive SDX and 1/3 of the participants will receive placebo (withdrawal design) in the 2-week Double-Blind Withdrawal Period (DBWP)
To qualify for this study, participants must:
Be 18 years old
BMI must be <35
Symptoms of Idiopathic Hypersomnia include feeling excessively tired
during the day despite a full night's sleep
Average a nightly Total Sleep Time (TST) of greater than or equal to 7
hours
If currently treated with nicotine replacement therapy, must be on same
regimen and dose for at least 2 months
Not have a current diagnosis of sleep apnea including treatment with CPAP
therapy
Not be a sleep walker or have Rapid Eye Movement (REM) sleep behavior
disorder
Periodic Limb Movement Disorder (PLMD) diagnosis older than 10 years
with current (last 60 days) treatment and/or symptoms of rhythmic
movements involving one or both legs during sleep
Not be a night shift worker or variable shifts 2 or more times per week
Not have any planned travel during the study that includes more than 3
time zones, or planned travel that includes 3 time zones on more than 2
occasions during the study
Not go to sleep for the night later than 1 am at a frequency of more than
once per week
Not currently have or have had a Major Depressive episode within 1 year
Have current or past substance abuse
Not have participated in a clinical study within the last 30 days
Not be pregnant or breastfeeding if female
If you are a woman of childbearing potential or a man whose partner is of
childbearing potential, you must agree to use effective birth control
Other criteria apply. You must call <site contact info> to verify eligibility