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
ClinicalTrials.gov Identifier:
NCT00345800
First received: June 28, 2006
Last updated: May 3, 2012
Last verified: May 2012
  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 on Potential Endocrine Changes at Currently Labeled Therapeutic Dose Regimens in the Treatment of Cataplexy in Adult Patients With Narcolepsy.

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • to monitor for endocrine changes in response to treatment of cataplexy with Xyrem eg: IGF-1. [ Time Frame: baseline, month 1 and month 3 (8 hours after bedtime dose) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Circadian rhythm, GH, cortisol, ACTH, DHEA-S, Prolactin, TSH, T4, electrolytes (NA, K, CA, P) and osmolality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Frequency, severity, nature and duration of adverse events reported by the subjects during the whole duration of the study [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Physical examination abnormalities evaluated at each visit [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Vital signs evaluated at each visit. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Calculation of BMI at each visit [ Time Frame: 3 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: 1
Xyrem Treatment
Drug: Sodium Oxybate (Xyrem)
500 mg/mL oral solution from 4.5 to 9g/day divided into two equal doses during 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
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
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00345800     History of Changes
Other Study ID Numbers: C00301, EudraCT Number:, 2005-004417-15
Study First Received: June 28, 2006
Last Updated: May 3, 2012
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 Disorders
Nervous System Diseases
Mental Disorders
Sodium Oxybate
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014