Clinical trial NCT00345800: Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
Official title: Single Center, Therapeutic Exploratory Clinical Trial to Evaluate the Safety of Sodium Oxybate (Xyrem) 500 mg/mL Oral Solution on Potential Endocrine Changes at Currently Labeled Therapeutic Dose Regimens (4.5 - 9 g/Day Divided Into Two Equal Doses) During 12 Weeks of Treatment of Cataplexy in Adult Patients With Narcolepsy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Narcolepsy With Cataplexy
Keywords: Endocrine Evaluation cataplexy
sodium oxybate (xyrem)
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-06-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

* Narcoleptic patients with cataplexy

Exclusion Criteria:

* Subjects not diagnosed with narcolepsy with cataplexy

Exclusion Criteria:

Primary outcomes:
measure: The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2)
timeFrame: Baseline (Visit 2) - approximately 1 day
measure: The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 1 Month of Treatment (Visit 3)
timeFrame: After 1 month of treatment (Visit 3)
measure: The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 3 Months of Treatment (Visit 4)
timeFrame: After 3 months of treatment (Visit 4)
Secondary outcomes:
measure: The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2)
timeFrame: Baseline (Visit 2) - approximately 1 day
measure: The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 3
timeFrame: Visit 3 (approximately 1 month)
measure: The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 4
timeFrame: Visit 4 (approximately 3 months)
measure: Cortisol Measured at Baseline (Visit 2)
timeFrame: Baseline (Visit 2) - approximately 1 day
measure: Cortisol Measured at Visit 3
timeFrame: Visit 3 (approximately 1 month)
measure: Cortisol Measured at Visit 4
timeFrame: Visit 4 (approximately 3 months)
measure: The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Baseline (Visit 2)
timeFrame: Baseline (Visit 2) - approximately 1 day
measure: The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 3
timeFrame: Visit 3 (approximately 1 month)
measure: The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 4
timeFrame: Visit 4 (approximately 3 months)
measure: The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Baseline (Visit 2)
timeFrame: Baseline (Visit 2) - approximately 1 day
measure: The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 3
timeFrame: Visit 3 (approximately 1 month)
measure: The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 4
timeFrame: Visit 4 (approximately 3 months)
measure: The Prolactin Measured in Fasting Conditions at Baseline (Visit 2)
timeFrame: Baseline (Visit 2) - approximately 1 day
measure: The Prolactin Measured in Fasting Conditions at Visit 3
timeFrame: Visit 3 (approximately 1 month)
measure: The Prolactin Measured in Fasting Conditions at Visit 4
timeFrame: Visit 4 (approximately 3 months)
measure: The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Baseline (Visit 2)
timeFrame: Baseline (Visit 2) - approximately 1 day
measure: The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 3
timeFrame: Visit 3 (approximately 1 month)
measure: The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 4
timeFrame: Visit 4 (approximately 3 months)
measure: The Total Thyroxin (T4) Measured in Fasting Conditions at Baseline (Visit 2)
timeFrame: Baseline (Visit 2) - approximately 1 day
measure: The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 3
timeFrame: Visit 3 (approximately 1 month)
measure: The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 4
timeFrame: Visit 4 (approximately 3 months)
measure: The Osmolality Measured in Fasting Conditions at Baseline (Visit 2)
timeFrame: Baseline (Visit 2) - approximately 1 day
measure: The Osmolality Measured in Fasting Conditions at Visit 3
timeFrame: Visit 3 (approximately 1 month)
measure: The Osmolality Measured in Fasting Conditions at Visit 4
timeFrame: Visit 4 (approximately 3 months)
measure: Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Baseline (Visit 2)
timeFrame: Baseline (Visit 2) - approximately 1 day
measure: The Electrolyte Phosphate (P) Measured in Fasting Conditions at Baseline (Visit 2)
timeFrame: Baseline (Visit 2) - approximately 1 day
measure: Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 3
timeFrame: Visit 3 (approximately 1 month)
measure: The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 3
timeFrame: Visit 3 (approximately 1 month)
measure: Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 4
timeFrame: Visit 4 (approximately 3 months)
measure: The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 4
timeFrame: Visit 4 (approximately 3 months)
measure: The Number of Patients Reporting at Least One Adverse Event (AE) During the Course of the Study
timeFrame: Visit 1 through the end of the study (approximately 4 months)
measure: The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study
timeFrame: Visit 1 through the end of the study (approximately 4 months)
measure: The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study
timeFrame: Visit 1 through the end of the study (approximately 4 months)
Other outcomes:
Locations:
city: Liège
country: Belgium
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: