Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
- Registration Number
- NCT00345800
- Lead Sponsor
- UCB Pharma SA
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria:
- Narcoleptic patients with cataplexy
- Subjects not diagnosed with narcolepsy with cataplexy
Exclusion Criteria:
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sodium Oxybate Sodium Oxybate (Xyrem) * 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
- Primary Outcome Measures
Name Time Method The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 1 Month of Treatment (Visit 3) After 1 month of treatment (Visit 3) An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 3.
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2) Baseline (Visit 2) - approximately 1 day An assay of IGF-1 was done from blood sampled about 10 hours after bedtime on Visit 2.
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 3 Months of Treatment (Visit 4) After 3 months of treatment (Visit 4) An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 4.
- Secondary Outcome Measures
Name Time Method The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 3 Visit 3 (approximately 1 month) Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying GH.
Cortisol Measured at Visit 4 Visit 4 (approximately 3 months) Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying cortisol.
The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 3 Visit 3 (approximately 1 month) An assay of T4 was done from blood sampled about 10 hours postdose on Visit 3.
The Osmolality Measured in Fasting Conditions at Visit 4 Visit 4 (approximately 3 months) An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 4.
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Baseline (Visit 2) Baseline (Visit 2) - approximately 1 day An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2.
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Baseline (Visit 2) Baseline (Visit 2) - approximately 1 day An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2.
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 4 Visit 4 (approximately 3 months) An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 4.
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Baseline (Visit 2) Baseline (Visit 2) - approximately 1 day An assay of DHEA-S was done from blood sampled about 10 hours after bedtime on Visit 2.
The Prolactin Measured in Fasting Conditions at Visit 3 Visit 3 (approximately 1 month) An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 3.
The Total Thyroxin (T4) Measured in Fasting Conditions at Baseline (Visit 2) Baseline (Visit 2) - approximately 1 day An assay of T4 was done from blood sampled about 10 hours after bedtime on Visit 2.
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 4 Visit 4 (approximately 3 months) An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4.
The Prolactin Measured in Fasting Conditions at Visit 4 Visit 4 (approximately 3 months) An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 4.
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 4 Visit 4 (approximately 3 months) An assay of TSH was done from blood sampled about 10 hours postdose on Visit 4.
The Number of Patients Reporting at Least One Adverse Event (AE) During the Course of the Study Visit 1 through the end of the study (approximately 4 months) 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.
The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2) Baseline (Visit 2) - approximately 1 day 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.
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Baseline (Visit 2) Baseline (Visit 2) - approximately 1 day An assay of ACTH was done from blood sampled about 10 hours after bedtime on Visit 2.
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 3 Visit 3 (approximately 1 month) An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 3.
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Baseline (Visit 2) Baseline (Visit 2) - approximately 1 day An assay of TSH was done from blood sampled about 10 hours after bedtime on Visit 2.
The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 4 Visit 4 (approximately 3 months) An assay of T4 was done from blood sampled about 10 hours postdose on Visit 4.
The Osmolality Measured in Fasting Conditions at Baseline (Visit 2) Baseline (Visit 2) - approximately 1 day An assay of osmolality was done from blood sampled about 10 hours after bedtime on Visit 2.
The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 4 Visit 4 (approximately 3 months) Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying GH.
Cortisol Measured at Baseline (Visit 2) Baseline (Visit 2) - approximately 1 day 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.
Cortisol Measured at Visit 3 Visit 3 (approximately 1 month) Blood was sampled predose and and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying cortisol.
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 3 Visit 3 (approximately 1 month) An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 3.
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 4 Visit 4 (approximately 3 months) An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 4.
The Prolactin Measured in Fasting Conditions at Baseline (Visit 2) Baseline (Visit 2) - approximately 1 day An assay of prolactin was done from blood sampled about 10 hours after bedtime on Visit 2.
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 3 Visit 3 (approximately 1 month) An assay of TSH was done from blood sampled about 10 hours postdose on Visit 3.
The Osmolality Measured in Fasting Conditions at Visit 3 Visit 3 (approximately 1 month) An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 3.
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 3 Visit 3 (approximately 1 month) An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3.
The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study Visit 1 through the end of the study (approximately 4 months) 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
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 3 Visit 3 (approximately 1 month) An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3.
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 4 Visit 4 (approximately 3 months) An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4.
The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study Visit 1 through the end of the study (approximately 4 months) 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.