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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier:
NCT00345800
First received: June 28, 2006
Last updated: June 18, 2015
Last verified: June 2015
  Purpose
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.

Condition Intervention Phase
Narcolepsy With Cataplexy
Drug: Sodium Oxybate (Xyrem)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • The insulin-like growth factor 1 (IGF-1) measured in fasting conditions at Baseline (Visit 2) [ Time Frame: Baseline (Visit 2) - approximately 1 day ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The circadian rhythm of the growth hormone (GH) measured at Baseline (Visit 2) [ Time Frame: Baseline (Visit 2) - approximately 1 day ] [ Designated as safety issue: No ]
  • The circadian rhythm of the growth hormone (GH) measured at Visit 3 [ Time Frame: Visit 3 (approximately 1 month) ] [ Designated as safety issue: No ]
  • The circadian rhythm of the growth hormone (GH) measured at Visit 4 [ Time Frame: Visit 4 (approximately 3 months) ] [ Designated as safety issue: No ]
  • Cortisol measured at Baseline (Visit 2) [ Time Frame: Baseline (Visit 2) - approximately 1 day ] [ Designated as safety issue: No ]
  • Cortisol measured at Visit 3 [ Time Frame: Visit 3 (approximately 1 month) ] [ Designated as safety issue: No ]
  • Cortisol measured at Visit 4 [ Time Frame: Visit 4 (approximately 3 months) ] [ Designated as safety issue: No ]
  • The adrenocorticotropic hormone (ACTH) measured in fasting conditions at Baseline (Visit 2) [ Time Frame: Baseline (Visit 2) - approximately 1 day ] [ Designated as safety issue: No ]
  • The adrenocorticotropic hormone (ACTH) measured in fasting conditions at Visit 3 [ Time Frame: Visit 3 (approximately 1 month) ] [ Designated as safety issue: No ]
  • The adrenocorticotropic hormone (ACTH) measured in fasting conditions at Visit 4 [ Time Frame: Visit 4 (approximately 3 months) ] [ Designated as safety issue: No ]
  • The dehydroepiandrosterone sulfate (DHEA-S) measured in fasting conditions at Baseline (Visit 2) [ Time Frame: Baseline (Visit 2) - approximately 1 day ] [ Designated as safety issue: No ]
  • The dehydroepiandrosterone sulfate (DHEA-S) measured in fasting conditions at Visit 3 [ Time Frame: Visit 3 (approximately 1 month) ] [ Designated as safety issue: No ]
  • The dehydroepiandrosterone sulfate (DHEA-S) measured in fasting conditions at Visit 4 [ Time Frame: Visit 4 (approximately 3 months) ] [ Designated as safety issue: No ]
  • The prolactin measured in fasting conditions at Baseline (Visit 2) [ Time Frame: Baseline (Visit 2) - approximately 1 day ] [ Designated as safety issue: No ]
  • The prolactin measured in fasting conditions at Visit 3 [ Time Frame: Visit 3 (approximately 1 month) ] [ Designated as safety issue: No ]
  • The prolactin measured in fasting conditions at Visit 4 [ Time Frame: Visit 4 (approximately 3 months) ] [ Designated as safety issue: No ]
  • The thyroid stimulating hormone (TSH) measured in fasting conditions at Baseline (Visit 2) [ Time Frame: Baseline (Visit 2) - approximately 1 day ] [ Designated as safety issue: No ]
  • The thyroid stimulating hormone (TSH) measured in fasting conditions at Visit 3 [ Time Frame: Visit 3 (approximately 1 month) ] [ Designated as safety issue: No ]
  • The thyroid stimulating hormone (TSH) measured in fasting conditions at Visit 4 [ Time Frame: Visit 4 (approximately 3 months) ] [ Designated as safety issue: No ]
  • The total thyroxin (T4) measured in fasting conditions at Baseline (Visit 2) [ Time Frame: Baseline (Visit 2) - approximately 1 day ] [ Designated as safety issue: No ]
  • The total thyroxin (T4) measured in fasting conditions at Visit 3 [ Time Frame: Visit 3 (approximately 1 month) ] [ Designated as safety issue: No ]
  • The total thyroxin (T4) measured in fasting conditions at Visit 4 [ Time Frame: Visit 4 (approximately 3 months) ] [ Designated as safety issue: No ]
  • The osmolality measured in fasting conditions at Baseline (Visit 2) [ Time Frame: Baseline (Visit 2) - approximately 1 day ] [ Designated as safety issue: No ]
  • The osmolality measured in fasting conditions at Visit 3 [ Time Frame: Visit 3 (approximately 1 month) ] [ Designated as safety issue: No ]
  • The osmolality measured in fasting conditions at Visit 4 [ Time Frame: Visit 4 (approximately 3 months) ] [ Designated as safety issue: No ]
  • Electrolytes (Na, K, Ca, P) measured in fasting conditions at Baseline (Visit 2) [ Time Frame: Baseline (Visit 2) - approximately 1 day ] [ Designated as safety issue: No ]
  • Electrolytes (Na, K, Ca, P) measured in fasting conditions at Visit 3 [ Time Frame: Visit 3 (approximately 1 month) ] [ Designated as safety issue: No ]
  • Electrolytes (Na, K, Ca, P) measured in fasting conditions at Visit 4 [ Time Frame: Visit 4 (approximately 3 months) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: April 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sodium Oxybate
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
Drug: 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
Other Name: Xyrem

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Narcoleptic patients with cataplexy

Exclusion Criteria:

  • Subjects not diagnosed with narcolepsy with cataplexy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345800

Locations
Belgium
Liège, Belgium
Sponsors and Collaborators
UCB Pharma SA
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Responsible Party: UCB Pharma SA
ClinicalTrials.gov Identifier: NCT00345800     History of Changes
Other Study ID Numbers: C00301  2005-004417-15 
Study First Received: June 28, 2006
Last Updated: June 18, 2015
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by UCB Pharma:
Endocrine Evaluation cataplexy
sodium oxybate (xyrem)

Additional relevant MeSH terms:
Narcolepsy
Cataplexy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Sodium Oxybate
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2016