Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Narcolepsy With Cataplexy
Intervention: Sodium Oxybate (Xyrem) (Drug)
Phase: Phase 4
Sponsored by: UCB
Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)
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
Official title: Single Center, Therapeutic Exploratory Clinical Trial to Evaluate the Safety of Sodium Oxybate on Potential Endocrine Changes at Currently Labeled Therapeutic Dose Regimens in the Treatment of Cataplexy in Adult Patients With Narcolepsy.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: to monitor for endocrine changes in response to treatment of cataplexy with Xyrem eg: IGF-1.
Circadian rhythm, GH, cortisol, ACTH, DHEA-S, Prolactin, TSH, T4, electrolytes (NA, K, CA, P) and osmolality
Frequency, severity, nature and duration of adverse events reported by the subjects during the whole duration of the study
Physical examination abnormalities evaluated at each visit
Vital signs evaluated at each visit.
Calculation of BMI at each visit
Minimum age: 18 Years.
Maximum age: 65 Years.
- Narcoleptic patients with cataplexy
- Subjects not diagnosed with narcolepsy with cataplexy
Locations and Contacts
Starting date: April 2006
Ending date: January 2008
Last updated: April 28, 2008