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

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

Narcolepsy With Cataplexy Clinical Trial

Official title:
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.

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00345800
Study type	Interventional
Source	UCB Pharma
Contact
Status	Completed
Phase	Phase 1
Start date	April 10, 2006
Completion date	January 22, 2008

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