Summary:
The primary objectives of this study are:
- To evaluate the efficacy of Xyrem (sodium oxybate) oral solution in the treatment of cataplexy in pediatric subjects with narcolepsy.
- To evaluate the safety of Xyrem in the treatment of cataplexy in pediatric subjects with Narcolepsy for up to one year.
The secondary objectives of the study are:
- To evaluate the efficacy of Xyrem in the treatment of excessive daytime sleepiness (EDS) in pediatric subjects with narcolepsy with cataplexy.
- To characterize the pharmacokinetics (PK) of Xyrem in pediatric subjects (ages 7-17 years) with narcolepsy with cataplexy.
- To evaluate the safety of titrating Xyrem in pediatric subjects to an effective and tolerable dose.
Qualified Participants Must:
• Be children and adolescents who are diagnosed with narcolepsy with cataplexy
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Be currently treated with Xyrem or are Xyrem naïve, with or without concomitant stable stimulant use
Qualified Participants May Receive:
Subjects will receive reimbursement for taking part in this research study.