Back to resultsExploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
Primary Purpose
Narcolepsy With Cataplexy
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Sodium Oxybate (Xyrem)
Sponsored by
About this trial
This is an interventional treatment trial for Narcolepsy With Cataplexy focused on measuring Endocrine Evaluation cataplexy, sodium oxybate (xyrem)
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria: Narcoleptic patients with cataplexy Exclusion Criteria: Subjects not diagnosed with narcolepsy with cataplexy Exclusion Criteria:
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sodium Oxybate
Arm Description
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
Outcomes
Primary Outcome Measures
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of IGF-1 was done from blood sampled about 10 hours after bedtime on Visit 2.
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 1 Month of Treatment (Visit 3)
An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 3.
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 3 Months of Treatment (Visit 4)
An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 4.
Secondary Outcome Measures
The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2)
Blood was sampled at Baseline (Visit 2) at bedtime 10:00 pm and 1, 2, 4, 8, 12, 16, and 20 hours after bedtime for assaying GH.
The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 3
Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying GH.
The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 4
Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying GH.
Cortisol Measured at Baseline (Visit 2)
Blood was sampled at Baseline (Visit 2) at bedtime 10:00 pm and 1, 2, 4, 8, 12, 16, and 20 hours after bedtime for assaying cortisol.
Cortisol Measured at Visit 3
Blood was sampled predose and and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying cortisol.
Cortisol Measured at Visit 4
Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying cortisol.
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of ACTH was done from blood sampled about 10 hours after bedtime on Visit 2.
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 3
An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 3.
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 4
An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 4.
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of DHEA-S was done from blood sampled about 10 hours after bedtime on Visit 2.
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 3
An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 3.
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 4
An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 4.
The Prolactin Measured in Fasting Conditions at Baseline (Visit 2)
An assay of prolactin was done from blood sampled about 10 hours after bedtime on Visit 2.
The Prolactin Measured in Fasting Conditions at Visit 3
An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 3.
The Prolactin Measured in Fasting Conditions at Visit 4
An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 4.
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of TSH was done from blood sampled about 10 hours after bedtime on Visit 2.
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 3
An assay of TSH was done from blood sampled about 10 hours postdose on Visit 3.
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 4
An assay of TSH was done from blood sampled about 10 hours postdose on Visit 4.
The Total Thyroxin (T4) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of T4 was done from blood sampled about 10 hours after bedtime on Visit 2.
The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 3
An assay of T4 was done from blood sampled about 10 hours postdose on Visit 3.
The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 4
An assay of T4 was done from blood sampled about 10 hours postdose on Visit 4.
The Osmolality Measured in Fasting Conditions at Baseline (Visit 2)
An assay of osmolality was done from blood sampled about 10 hours after bedtime on Visit 2.
The Osmolality Measured in Fasting Conditions at Visit 3
An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 3.
The Osmolality Measured in Fasting Conditions at Visit 4
An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 4.
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2.
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Baseline (Visit 2)
An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2.
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 3
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3.
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 3
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3.
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 4
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4.
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 4
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4.
The Number of Patients Reporting at Least One Adverse Event (AE) During the Course of the Study
An AE was classified as a treatment-emergent AE (TEAE) if its onset date and time was on or after the first study drug administration. Number of subjects with at least one TEAE is reported below.
The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study
An AE was classified as a treatment-emergent AE (TEAE) if its onset date and time was on or after the first study drug administration. Number of subjects with TEAE that led to temporarily discontinuation of study drug is reported below.
The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study
A Serious Adverse Event is any untoward medical occurrence that at any dose • results in death, • is life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00345800
Brief Title
Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
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 Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 10, 2006 (Actual)
Primary Completion Date
January 22, 2008 (Actual)
Study Completion Date
January 22, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma SA
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy With Cataplexy
Keywords
Endocrine Evaluation cataplexy, sodium oxybate (xyrem)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium Oxybate
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Sodium Oxybate (Xyrem)
Other Intervention Name(s)
Xyrem
Intervention Description
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
Primary Outcome Measure Information:
Title
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2)
Description
An assay of IGF-1 was done from blood sampled about 10 hours after bedtime on Visit 2.
Time Frame
Baseline (Visit 2) - approximately 1 day
Title
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 1 Month of Treatment (Visit 3)
Description
An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 3.
Time Frame
After 1 month of treatment (Visit 3)
Title
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 3 Months of Treatment (Visit 4)
Description
An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 4.
Time Frame
After 3 months of treatment (Visit 4)
Secondary Outcome Measure Information:
Title
The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2)
Description
Blood was sampled at Baseline (Visit 2) at bedtime 10:00 pm and 1, 2, 4, 8, 12, 16, and 20 hours after bedtime for assaying GH.
Time Frame
Baseline (Visit 2) - approximately 1 day
Title
The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 3
Description
Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying GH.
Time Frame
Visit 3 (approximately 1 month)
Title
The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 4
Description
Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying GH.
Time Frame
Visit 4 (approximately 3 months)
Title
Cortisol Measured at Baseline (Visit 2)
Description
Blood was sampled at Baseline (Visit 2) at bedtime 10:00 pm and 1, 2, 4, 8, 12, 16, and 20 hours after bedtime for assaying cortisol.
Time Frame
Baseline (Visit 2) - approximately 1 day
Title
Cortisol Measured at Visit 3
Description
Blood was sampled predose and and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 3 for assaying cortisol.
Time Frame
Visit 3 (approximately 1 month)
Title
Cortisol Measured at Visit 4
Description
Blood was sampled predose and 1, 2, 4, 8, 12, 16, and 20 hours postdose at Visit 4 for assaying cortisol.
Time Frame
Visit 4 (approximately 3 months)
Title
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Baseline (Visit 2)
Description
An assay of ACTH was done from blood sampled about 10 hours after bedtime on Visit 2.
Time Frame
Baseline (Visit 2) - approximately 1 day
Title
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 3
Description
An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 3.
Time Frame
Visit 3 (approximately 1 month)
Title
The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 4
Description
An assay of ACTH was done from blood sampled about 10 hours postdose on Visit 4.
Time Frame
Visit 4 (approximately 3 months)
Title
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Baseline (Visit 2)
Description
An assay of DHEA-S was done from blood sampled about 10 hours after bedtime on Visit 2.
Time Frame
Baseline (Visit 2) - approximately 1 day
Title
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 3
Description
An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 3.
Time Frame
Visit 3 (approximately 1 month)
Title
The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 4
Description
An assay of DHEA-S was done from blood sampled about 10 hours postdose on Visit 4.
Time Frame
Visit 4 (approximately 3 months)
Title
The Prolactin Measured in Fasting Conditions at Baseline (Visit 2)
Description
An assay of prolactin was done from blood sampled about 10 hours after bedtime on Visit 2.
Time Frame
Baseline (Visit 2) - approximately 1 day
Title
The Prolactin Measured in Fasting Conditions at Visit 3
Description
An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 3.
Time Frame
Visit 3 (approximately 1 month)
Title
The Prolactin Measured in Fasting Conditions at Visit 4
Description
An assay of prolactin was done from blood sampled about 10 hours postdose on Visit 4.
Time Frame
Visit 4 (approximately 3 months)
Title
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Baseline (Visit 2)
Description
An assay of TSH was done from blood sampled about 10 hours after bedtime on Visit 2.
Time Frame
Baseline (Visit 2) - approximately 1 day
Title
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 3
Description
An assay of TSH was done from blood sampled about 10 hours postdose on Visit 3.
Time Frame
Visit 3 (approximately 1 month)
Title
The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 4
Description
An assay of TSH was done from blood sampled about 10 hours postdose on Visit 4.
Time Frame
Visit 4 (approximately 3 months)
Title
The Total Thyroxin (T4) Measured in Fasting Conditions at Baseline (Visit 2)
Description
An assay of T4 was done from blood sampled about 10 hours after bedtime on Visit 2.
Time Frame
Baseline (Visit 2) - approximately 1 day
Title
The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 3
Description
An assay of T4 was done from blood sampled about 10 hours postdose on Visit 3.
Time Frame
Visit 3 (approximately 1 month)
Title
The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 4
Description
An assay of T4 was done from blood sampled about 10 hours postdose on Visit 4.
Time Frame
Visit 4 (approximately 3 months)
Title
The Osmolality Measured in Fasting Conditions at Baseline (Visit 2)
Description
An assay of osmolality was done from blood sampled about 10 hours after bedtime on Visit 2.
Time Frame
Baseline (Visit 2) - approximately 1 day
Title
The Osmolality Measured in Fasting Conditions at Visit 3
Description
An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 3.
Time Frame
Visit 3 (approximately 1 month)
Title
The Osmolality Measured in Fasting Conditions at Visit 4
Description
An assay of osmolality was done from blood sampled about 10 hours postdose on Visit 4.
Time Frame
Visit 4 (approximately 3 months)
Title
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Baseline (Visit 2)
Description
An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2.
Time Frame
Baseline (Visit 2) - approximately 1 day
Title
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Baseline (Visit 2)
Description
An assay of electrolytes was done from blood sampled about 10 hours after bedtime on Visit 2.
Time Frame
Baseline (Visit 2) - approximately 1 day
Title
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 3
Description
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3.
Time Frame
Visit 3 (approximately 1 month)
Title
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 3
Description
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 3.
Time Frame
Visit 3 (approximately 1 month)
Title
Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 4
Description
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4.
Time Frame
Visit 4 (approximately 3 months)
Title
The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 4
Description
An assay of electrolytes was done from blood sampled about 10 hours postdose on Visit 4.
Time Frame
Visit 4 (approximately 3 months)
Title
The Number of Patients Reporting at Least One Adverse Event (AE) During the Course of the Study
Description
An AE was classified as a treatment-emergent AE (TEAE) if its onset date and time was on or after the first study drug administration. Number of subjects with at least one TEAE is reported below.
Time Frame
Visit 1 through the end of the study (approximately 4 months)
Title
The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study
Description
An AE was classified as a treatment-emergent AE (TEAE) if its onset date and time was on or after the first study drug administration. Number of subjects with TEAE that led to temporarily discontinuation of study drug is reported below.
Time Frame
Visit 1 through the end of the study (approximately 4 months)
Title
The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study
Description
A Serious Adverse Event is any untoward medical occurrence that at any dose • results in death, • is life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect
Time Frame
Visit 1 through the end of the study (approximately 4 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria:
Narcoleptic patients with cataplexy
Exclusion Criteria:
Subjects not diagnosed with narcolepsy with cataplexy
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
+1 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
City
Liège
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000593/WC500057103.pdf
Description
Product Information
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
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