Date: 2014-12-02
Type of information: Initiation of patient enrollment
phase: 3
Announcement: initiation of patient enrollment
Company: Jazz Pharmaceuticals (Ireland)
Product: Xyrem® (sodium oxybate)
Action mechanism:
Disease: children and adolescents aged seven to 17 who have narcolepsy with cataplexy
Therapeutic area: CNS diseases - Neurological diseases
Country: USA, Europe
Trial
details: The Xyrem Pediatric Narcolepsy Study is a 52-week, Phase 3 randomized, double-blind, open-label, multicenter clinical trial that will evaluate the safety, efficacy and pharmacokinetics of Xyrem in patients aged seven to 17. The trial will enroll up to 100 pediatric patients globally at sites in the U.S. and several countries in Europe. (NCT02221869)
Latest
news: * On December 2, 2014, Jazz Pharmaceuticals announced that the first patients have been enrolled in a Phase 3 clinical trial to assess the safety and efficacy of Xyrem® (sodium oxybate) in children and adolescents aged seven to 17 who have narcolepsy with cataplexy.
Xyrem® is the only FDA approved treatment for narcolepsy with cataplexy in adults. The FDA approval was based on clinical data in primarily adult patients. While there has been a great deal of interest from the narcolepsy community to understand the utility of Xyrem in children or adolescents, there are no published randomized, placebo-controlled trials of Xyrem in pediatric patients. Given the limited knowledge about the use of Xyrem in children or adolescents, Jazz Pharmaceuticals worked with the FDA and key thought leaders to determine the viability of a clinical study to assess Xyrem in children and adolescents. Based on this work, the FDA submitted a Pediatric Written Request to Jazz Pharmaceuticals.
