Completed
PHASE1
INTERVENTIONAL
NCT00345800
Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
View on ClinicalTrials.gov
Updated Dec 15, 2025
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.
Interventions
Name:
Sodium Oxybate (Xyrem)
Type:
DRUG
Description:
* 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 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
Description:
An assay of IGF-1 was done from blood sampled about 10 hours after bedtime on Visit 2.
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)
Description:
An assay of IGF-1 was done from blood sampled about 10 hours postdose on 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)
Description:
An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 4.
Trial Information
NCT ID
NCT00345800
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
UCB Pharma SA
Last Updated
December 15, 2025