drugset / Trial / NCT00345800

Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes

NCT00345800

Phase 1 Completed 25 enrolled UCB Pharma
NaSingle-groupOpen-labelTreatment

Summary

To monitor for endocrine changes in response to treatment of cataplexy with Xyrem, to focus on the hypothalamic pituitary axis and to confirm the safety of Xyrem on potential endocrine changes.

Timeline

Start
2006-04-10
Primary completion
2008-01-22
Completion
2008-01-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Oxybate Unknown 4.5 g Oral
Subject Sodium Oxybate Unknown 9 g Oral