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.
The circadian rhythm of the growth hormone (GH) measured at Baseline (Visit 2)The circadian rhythm of the growth hormone (GH) measured at Visit 3
The circadian rhythm of the growth hormone (GH) measured at Visit 4
Cortisol measured at Baseline (Visit 2)
Cortisol measured at Visit 3
Cortisol measured at Visit 4
The adrenocorticotropic hormone (ACTH) measured in fasting conditions at Baseline (Visit 2)
The adrenocorticotropic hormone (ACTH) measured in fasting conditions at Visit 3
The adrenocorticotropic hormone (ACTH) measured in fasting conditions at Visit 4
The dehydroepiandrosterone sulfate (DHEA-S) measured in fasting conditions at Baseline (Visit 2)
The dehydroepiandrosterone sulfate (DHEA-S) measured in fasting conditions at Visit 3
The dehydroepiandrosterone sulfate (DHEA-S) measured in fasting conditions at Visit 4
The prolactin measured in fasting conditions at Baseline (Visit 2)
The prolactin measured in fasting conditions at Visit 3
The prolactin measured in fasting conditions at Visit 4
The thyroid stimulating hormone (TSH) measured in fasting conditions at Baseline (Visit 2)
The thyroid stimulating hormone (TSH) measured in fasting conditions at Visit 3
The thyroid stimulating hormone (TSH) measured in fasting conditions at Visit 4
The total thyroxin (T4) measured in fasting conditions at Baseline (Visit 2)
The total thyroxin (T4) measured in fasting conditions at Visit 3
The total thyroxin (T4) measured in fasting conditions at Visit 4
The osmolality measured in fasting conditions at Baseline (Visit 2)
The osmolality measured in fasting conditions at Visit 3
The osmolality measured in fasting conditions at Visit 4
Electrolytes (Na, K, Ca, P) measured in fasting conditions at Baseline (Visit 2)
Electrolytes (Na, K, Ca, P) measured in fasting conditions at Visit 3
Electrolytes (Na, K, Ca, P) measured in fasting conditions at Visit 4
The number of patients reporting at least one Adverse Event (AE) during the course of the study
The number of patient withdrawal due to Adverse Events (AEs) during the course of the study
The number of patients reporting at least one Serious Adverse Event (SAE) during the course of the study
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.