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

Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Narcolepsy With Cataplexy

Intervention: Sodium Oxybate (Xyrem) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: UCB Pharma SA

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)

Summary

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.

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

The insulin-like growth factor 1 (IGF-1) measured in fasting conditions at Baseline (Visit 2)

The insulin-like growth factor 1 (IGF-1) measured in fasting conditions 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)

Secondary outcome:

The circadian rhythm of the growth hormone (GH) measured at Baseline (Visit 2)

The circadian rhythm of the growth hormone (GH) measured at Visit 3

The circadian rhythm of the growth hormone (GH) measured at Visit 4

Cortisol measured at Baseline (Visit 2)

Cortisol measured at Visit 3

Cortisol measured at Visit 4

The adrenocorticotropic hormone (ACTH) measured in fasting conditions at Baseline (Visit 2)

The adrenocorticotropic hormone (ACTH) measured in fasting conditions at Visit 3

The adrenocorticotropic hormone (ACTH) measured in fasting conditions at Visit 4

The dehydroepiandrosterone sulfate (DHEA-S) measured in fasting conditions at Baseline (Visit 2)

The dehydroepiandrosterone sulfate (DHEA-S) measured in fasting conditions at Visit 3

The dehydroepiandrosterone sulfate (DHEA-S) measured in fasting conditions at Visit 4

The prolactin measured in fasting conditions at Baseline (Visit 2)

The prolactin measured in fasting conditions at Visit 3

The prolactin measured in fasting conditions at Visit 4

The thyroid stimulating hormone (TSH) measured in fasting conditions at Baseline (Visit 2)

The thyroid stimulating hormone (TSH) measured in fasting conditions at Visit 3

The thyroid stimulating hormone (TSH) measured in fasting conditions at Visit 4

The total thyroxin (T4) measured in fasting conditions at Baseline (Visit 2)

The total thyroxin (T4) measured in fasting conditions at Visit 3

The total thyroxin (T4) measured in fasting conditions at Visit 4

The osmolality measured in fasting conditions at Baseline (Visit 2)

The osmolality measured in fasting conditions at Visit 3

The osmolality measured in fasting conditions at Visit 4

Electrolytes (Na, K, Ca, P) measured in fasting conditions at Baseline (Visit 2)

Electrolytes (Na, K, Ca, P) measured in fasting conditions at Visit 3

Electrolytes (Na, K, Ca, P) measured in fasting conditions at Visit 4

The number of patients reporting at least one Adverse Event (AE) during the course of the study

The number of patient withdrawal due to Adverse Events (AEs) during the course of the study

The number of patients reporting at least one Serious Adverse Event (SAE) during the course of the study

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Narcoleptic patients with cataplexy

Exclusion Criteria:

- Subjects not diagnosed with narcolepsy with cataplexy

Locations and Contacts

Li├Ęge, Belgium
Additional Information

Starting date: April 2006
Last updated: June 18, 2015

Page last updated: August 23, 2015

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