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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00345800
First Posted: June 29, 2006
Last Update Posted: June 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )
  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
Intervention Model: Single Group Assignment
Masking: None (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 ( UCB Pharma SA ):

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 ]
  • 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) ]

Secondary Outcome Measures:
  • 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) ]

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

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Narcoleptic patients with cataplexy

Exclusion Criteria:

  • Subjects not diagnosed with narcolepsy with cataplexy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( EudraCT Number )
First Submitted: June 28, 2006
First Posted: June 29, 2006
Last Update Posted: June 19, 2015
Last Verified: June 2015

Keywords provided by UCB Pharma ( UCB Pharma SA ):
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