Clinical Trial: Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Regi

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 Summary:
Sponsor: UCB Pharma SA

Current Primary Outcome:

  • The insulin-like growth factor 1 (IGF-1) measured in fasting conditions at Baseline (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) [ 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) [ Time Frame: After 3 months of treatment (Visit 4) ]


Original Primary Outcome: to monitor for endocrine changes in response to treatment of cataplexy with xyrem.

Current Secondary Outcome:

  • The circadian rhythm of the growth hormone (GH) measured at Baseline (Visit 2) [ Time Frame: Baseline (Visit 2) - approximately 1 day ]
  • The circadian rhythm of the growth hormone (GH) measured at Visit 3 [ Time Frame: Visit 3 (approximately 1 month) ]
  • The circadian rhythm of the growth hormone (GH) measured at Visit 4 [ Time Frame: Visit 4 (approximately 3 months) ]
  • Cortisol measured at Baseline (Visit 2) [ Time Frame: Baseline (Visit 2) - approximately 1 day ]
  • Cortisol measured at Visit 3 [ Time Frame: Visit 3 (approximately 1 month) ]
  • Cortisol measured at Visit 4 [ Time Frame: Visit 4 (approximately 3 months) ]
  • The adrenocorticotropic hormone (ACTH) measured in fasting conditions at Baseline (Visit 2) [ Time Frame: Baseline (Visit 2) - approximately 1 day ]
  • The adrenocorticotropic hormone (ACTH) measured in fasting conditions at Visit 3 [ Time Frame: Visit 3 (approximately 1 month) ]
  • The adrenocorticotropic hormone (ACTH) measured in fasting conditions at Visit 4 [ Time Frame: Visit 4 (approximately 3 months) ]
  • The dehydroepiandrosterone sulfate (DHEA-S) measured in fasting conditions at Baseline (Visit 2) [ Time Frame: Baseline (Visit 2) - approximately 1 day ]
  • The dehydroepiandrosterone sulfate (DHEA-S) measured in fasting conditions at Visit 3 [ Time Frame: Visit 3 (approximately 1 month) ]
  • The dehydroepiandrosterone sulfate (DHEA-S) measured in fasting conditions at Visit 4 [ Time Frame: Visit 4 (approximately 3 months) ]
  • The prolactin measured in fasting conditions at Baseline (Visit 2) [ Time Frame: Baseline (Visit 2) - approximately 1 day ]
  • The prolactin measured in fasting conditions at Visit 3 [ Time Frame: Visit 3 (approximately 1 month) ]
  • The prolactin measured in fasting conditions at Visit 4 [ Time Frame: Visit 4 (approximately 3 months) ]
  • The thyroid stimulating hormone (TSH) measured in fasting conditions at Baseline (Visit 2) [ Time Frame: Baseline (Visit 2) - approximately 1 day ]
  • The thyroid stimulating hormone (TSH) measured in fasting conditions at Visit 3 [ Time Frame: Visit 3 (approximately 1 month) ]
  • The thyroid stimulating hormone (TSH) measured in fasting conditions at Visit 4 [ Time Frame: Visit 4 (approximately 3 months) ]
  • The total thyroxin (T4) measured in fasting conditions at Baseline (Visit 2) [ Time Frame: Baseline (Visit 2) - approximately 1 day ]
  • The total thyroxin (T4) measured in fasting conditions at Visit 3 [ Time Frame: Visit 3 (approximately 1 month) ]
  • The total thyroxin (T4) measured in fasting conditions at Visit 4 [ Time Frame: Visit 4 (approximately 3 months) ]
  • The osmolality measured in fasting conditions at Baseline (Visit 2) [ Time Frame: Baseline (Visit 2) - approximately 1 day ]
  • The osmolality measured in fasting conditions at Visit 3 [ Time Frame: Visit 3 (approximately 1 month) ]
  • The osmolality measured in fasting conditions at Visit 4 [ Time Frame: Visit 4 (approximately 3 months) ]
  • Electrolytes (Na, K, Ca, P) measured in fasting conditions at Baseline (Visit 2) [ Time Frame: Baseline (Visit 2) - approximately 1 day ]
  • Electrolytes (Na, K, Ca, P) measured in fasting conditions at Visit 3 [ Time Frame: Visit 3 (approximately 1 month) ]
  • Electrolytes (Na, K, Ca, P) measured in fasting conditions at 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 [ 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 [ 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 [ Time Frame: Visit 1 through the end of the study (approximately 4 months) ]


Original Secondary Outcome: General tolerability

Information By: UCB Pharma

Dates:
Date Received: June 28, 2006
Date Started: April 2006
Date Completion:
Last Updated: June 18, 2015
Last Verified: June 2015