Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00345800

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 IV

MedlinePlus related topics: Club Drugs

Drug Information available for: Sodium oxybate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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.

Further study details as provided by UCB:

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) ]

Secondary Outcome Measures:

Circadian rhythm, GH, cortisol, ACTH, DHEA-S, Prolactin, TSH, T4, electrolytes (NA, K, CA, P) and osmolality [ Time Frame: 3 months ]
Frequency, severity, nature and duration of adverse events reported by the subjects during the whole duration of the study [ Time Frame: 3 months ]
Physical examination abnormalities evaluated at each visit [ Time Frame: 3 months ]
Vital signs evaluated at each visit. [ Time Frame: 3 months ]
Calculation of BMI at each visit [ Time Frame: 3 months ]

Estimated 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
1: Experimental 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

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

Locations

Belgium

Liège, Belgium

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	C00301, EudraCT Number:, 2005-004417-15
Study First Received:	June 28, 2006
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00345800
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by UCB:

Endocrine Evaluation cataplexy
sodium oxybate (xyrem)

Study placed in the following topic categories:

Cataplexy
Mental Disorders
Narcolepsy
Dyssomnias
Sleep Disorders

Disorders of Excessive Somnolence
Sodium Oxybate
Gelineau's syndrome
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Anesthetics, Intravenous
Adjuvants, Anesthesia
Anesthetics, General
Therapeutic Uses
Physiological Effects of Drugs

Nervous System Diseases
Central Nervous System Depressants
Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009