Clinical Trial 52994

Winter Park, FL 32789


Idiopathic Hypersomnia (IH) - Sleep Disorders - Winter Park FL (Metro Orlando)
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SDX 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


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


Not be a sleep walker or have Rapid Eye Movement (REM) sleep behavior


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

Qualified Participants May Receive:

Compensation up to $2,100

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.