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

Available At:

Clinical Site Partners Orlando
1788 W. Fairbanks Ave
Winter Park, FL 32789
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If you or someone you care for is interested in participating and lives within 50 miles of the location shown, please complete the form below and click 'Submit'

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.