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

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:

Genetics Home Reference related topics: narcolepsy

MedlinePlus related topics: Club Drugs

Drug Information available for: Sodium Oxybate

Genetic and Rare Diseases Information Center resources: Narcolepsy

U.S. FDA Resources

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


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

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 ( EudraCT Number )
Study First Received:	June 28, 2006
Last Updated:	June 18, 2015

Keywords provided by UCB Pharma ( UCB Pharma SA ):


Endocrine Evaluation cataplexy sodium oxybate (xyrem)

Additional relevant MeSH terms:


Sleep Disorders, Intrinsic Narcolepsy Cataplexy Disorders of Excessive Somnolence 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 September 21, 2017