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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
* Active Substance: Sodium Oxybate * Pharmaceutical form: Oral Solution * Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks * Route of administration: Oral
Unnamed facility
Liège, Belgium
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of IGF-1 was done from blood sampled about 10 hours after bedtime on Visit 2.
Time frame: Baseline (Visit 2) - approximately 1 day
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 1 Month of Treatment (Visit 3)
An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 3.
Time frame: After 1 month of treatment (Visit 3)
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 3 Months of Treatment (Visit 4)
An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 4.
Time frame: After 3 months of treatment (Visit 4)
The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2)
Blood was sampled at Baseline (Visit 2) at bedtime 10:00 pm and 1, 2, 4, 8, 12, 16, and 20 hours after bedtime for assaying GH.
Time frame: Baseline (Visit 2) - approximately 1 day
The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 3
Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying GH.
Time frame: Visit 3 (approximately 1 month)
The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 4
Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying GH.
Time frame: Visit 4 (approximately 3 months)
Cortisol Measured at Baseline (Visit 2)
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Blood was sampled at Baseline (Visit 2) at bedtime 10:00 pm and 1, 2, 4, 8, 12, 16, and 20 hours after bedtime for assaying cortisol.
Time frame: Baseline (Visit 2) - approximately 1 day
Cortisol Measured at Visit 3
Blood was sampled predose and and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying cortisol.
Time frame: Visit 3 (approximately 1 month)
Cortisol Measured at Visit 4
Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying cortisol.
Time frame: Visit 4 (approximately 3 months)
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of ACTH was done from blood sampled about 10 hours after bedtime on Visit 2.
Time frame: Baseline (Visit 2) - approximately 1 day
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 3
An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 3.
Time frame: Visit 3 (approximately 1 month)
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 4
An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 4.
Time frame: Visit 4 (approximately 3 months)
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of DHEA-S was done from blood sampled about 10 hours after bedtime on Visit 2.
Time frame: Baseline (Visit 2) - approximately 1 day
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 3
An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 3.
Time frame: Visit 3 (approximately 1 month)
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 4
An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 4.
Time frame: Visit 4 (approximately 3 months)
The Prolactin Measured in Fasting Conditions at Baseline (Visit 2)
An assay of prolactin was done from blood sampled about 10 hours after bedtime on Visit 2.
Time frame: Baseline (Visit 2) - approximately 1 day
The Prolactin Measured in Fasting Conditions at Visit 3
An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 3.
Time frame: Visit 3 (approximately 1 month)
The Prolactin Measured in Fasting Conditions at Visit 4
An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 4.
Time frame: Visit 4 (approximately 3 months)
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of TSH was done from blood sampled about 10 hours after bedtime on Visit 2.
Time frame: Baseline (Visit 2) - approximately 1 day
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 3
An assay of TSH was done from blood sampled about 10 hours postdose on Visit 3.
Time frame: Visit 3 (approximately 1 month)
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 4
An assay of TSH was done from blood sampled about 10 hours postdose on Visit 4.
Time frame: Visit 4 (approximately 3 months)
The Total Thyroxin (T4) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of T4 was done from blood sampled about 10 hours after bedtime on Visit 2.
Time frame: Baseline (Visit 2) - approximately 1 day
The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 3
An assay of T4 was done from blood sampled about 10 hours postdose on Visit 3.
Time frame: Visit 3 (approximately 1 month)
The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 4
An assay of T4 was done from blood sampled about 10 hours postdose on Visit 4.
Time frame: Visit 4 (approximately 3 months)
The Osmolality Measured in Fasting Conditions at Baseline (Visit 2)
An assay of osmolality was done from blood sampled about 10 hours after bedtime on Visit 2.
Time frame: Baseline (Visit 2) - approximately 1 day
The Osmolality Measured in Fasting Conditions at Visit 3
An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 3.
Time frame: Visit 3 (approximately 1 month)
The Osmolality Measured in Fasting Conditions at Visit 4
An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 4.
Time frame: Visit 4 (approximately 3 months)
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2.
Time frame: Baseline (Visit 2) - approximately 1 day
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2.
Time frame: Baseline (Visit 2) - approximately 1 day
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 3
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3.
Time frame: Visit 3 (approximately 1 month)
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 3
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3.
Time frame: Visit 3 (approximately 1 month)
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 4
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4.
Time frame: Visit 4 (approximately 3 months)
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 4
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4.
Time frame: Visit 4 (approximately 3 months)
The Number of Patients Reporting at Least One Adverse Event (AE) During the Course of the Study
An AE was classified as a treatment-emergent AE (TEAE) if its onset date and time was on or after the first study drug administration. Number of subjects with at least one TEAE is reported below.
Time frame: Visit 1 through the end of the study (approximately 4 months)
The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study
An AE was classified as a treatment-emergent AE (TEAE) if its onset date and time was on or after the first study drug administration. Number of subjects with TEAE that led to temporarily discontinuation of study drug is reported below.
Time frame: Visit 1 through the end of the study (approximately 4 months)
The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study
A Serious Adverse Event is any untoward medical occurrence that at any dose • results in death, • is life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect
Time frame: Visit 1 through the end of the study (approximately 4 months)