Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
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ClinicalTrials.gov Identifier: NCT00345800 |
Recruitment Status
:
Completed
First Posted
: June 29, 2006
Last Update Posted
: June 19, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Narcolepsy With Cataplexy | Drug: Sodium Oxybate (Xyrem) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
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. |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | January 2008 |
Actual Study Completion Date : | January 2008 |

Arm | Intervention/treatment |
---|---|
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
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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
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- 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) ]
- 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) ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Narcoleptic patients with cataplexy
Exclusion Criteria:
- Subjects not diagnosed with narcolepsy with cataplexy

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
Belgium | |
Liège, Belgium |
Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Responsible Party: | UCB Pharma SA |
ClinicalTrials.gov Identifier: | NCT00345800 History of Changes |
Other Study ID Numbers: |
C00301 2005-004417-15 ( EudraCT Number ) |
First Posted: | June 29, 2006 Key Record Dates |
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:
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 |