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

Condition(s) targeted: Narcolepsy With Cataplexy

Intervention: Sodium Oxybate (Xyrem) (Drug)

Phase: Phase 4

Status: Completed

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 changes.

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.

Secondary outcome:

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. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Narcoleptic patients with cataplexy

Exclusion Criteria:

- Subjects not diagnosed with narcolepsy with cataplexy

Liège, Belgium

Starting date: April 2006
Ending date: January 2008
Last updated: April 28, 2008