A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy
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|ClinicalTrials.gov Identifier: NCT02221869|
Recruitment Status : Active, not recruiting
First Posted : August 21, 2014
Last Update Posted : June 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Narcolepsy With Cataplexy||Drug: Xyrem||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Actual Study Start Date :||October 1, 2014|
|Actual Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||June 2019|
Active Xyrem at a dose ≤9 g/night
Placebo Comparator: Xyrem Placebo
Xyrem placebo at a volume and regimen equivalent to the stable dose of Xyrem.
- Efficacy of Xyrem [ Time Frame: 2 Weeks ]Change in weekly number of cataplexy attacks (2 weeks). Two week double-blind comparison
- Xyrem Safety In Participants [ Time Frame: Up to 52 weeks ]Adverse events will be summarized by treatment Group and by dose.
- To Evaluate the efficacy of xyrem in the treatment of excessive daytimne sleepiness (EDS) in pediatric subjects with narcolepsy with cataplexy [ Time Frame: 2 Weeks ]Clinical Global Impression of Change (CGIc) for cataplexy severity. Change in the Epworth Sleepiness Scale for CHildren and Adolescents (ESS [CHAD}) score
- Overnight PK Sampling [ Time Frame: 2 Nights ]Overnight PK sampling for evaluation of AUC, Cmax, Tmax for subjects willing to participate in this part of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221869
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