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Single Center, Therapeutic Exploratory Clinical Trial to Evaluate the Safety of Sodium Oxybate (Xyrem) 500 mg/mL Oral Solution on Potential Endocrine Changes at Currently Labeled Therapeutic Dose Regimens (4.5 - 9 g/Day Divided Into Two Equal Doses) During 12 Weeks of Treatment of Cataplexy in Adult Patients With Narcolepsy.

Trial Profile

Single Center, Therapeutic Exploratory Clinical Trial to Evaluate the Safety of Sodium Oxybate (Xyrem) 500 mg/mL Oral Solution on Potential Endocrine Changes at Currently Labeled Therapeutic Dose Regimens (4.5 - 9 g/Day Divided Into Two Equal Doses) During 12 Weeks of Treatment of Cataplexy in Adult Patients With Narcolepsy.

Completed
Phase of Trial: Phase IV

Latest Information Update: 26 Jun 2015

At a glance

  • Drugs Sodium oxybate (Primary)
  • Indications Cataplexy
  • Focus Pharmacodynamics
  • Sponsors UCB
  • Most Recent Events

    • 31 Aug 2018 Biomarkers information updated
    • 20 Oct 2009 Actual end date (Jan 2008) added as reported by ClinicalTrials.gov.
    • 04 Jan 2008 Status changed from recruiting to in progress.
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