Study of the Efficacy and Safety of Xyrem in Pediatric Subjects with Narcolepsy with Cataplexy

Update Il y a 4 ans
Reference: EUCTR2014-001389-93

Woman and Man

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Extract

Primary objectives are: 1) To evaluate the efficacy of Xyrem (sodium oxybate) oral solution in the treatment of cataplexy in pediatric subjects with narcolepsy 2) To evaluate the safety of Xyrem in the treatment of cataplexy in pediatric subjects with narcolepsy for up to one year (and potentially more than one year in some subjects participating in a continuation of the open-label safety evaluation)


Inclusion criteria

  • Narcolepsy with Cataplexy