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.
Phase of Trial: Phase IV
Latest Information Update: 26 Jun 2015
At a glance
- Drugs Sodium oxybate (Primary)
- Indications Cataplexy
- Focus Pharmacodynamics
- Sponsors UCB
- 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.