Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
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.
2 other identifiers
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2006
CompletedFirst Submitted
Initial submission to the registry
June 28, 2006
CompletedFirst Posted
Study publicly available on registry
June 29, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 22, 2008
CompletedResults Posted
Study results publicly available
April 8, 2022
CompletedApril 8, 2022
February 1, 2022
1.8 years
June 28, 2006
February 8, 2018
February 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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)
An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 3.
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)
An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 4.
After 3 months of treatment (Visit 4)
Secondary Outcomes (33)
The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2)
Baseline (Visit 2) - approximately 1 day
The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 3
Visit 3 (approximately 1 month)
The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 4
Visit 4 (approximately 3 months)
Cortisol Measured at Baseline (Visit 2)
Baseline (Visit 2) - approximately 1 day
Cortisol Measured at Visit 3
Visit 3 (approximately 1 month)
- +28 more secondary outcomes
Study Arms (1)
Sodium Oxybate
EXPERIMENTAL* 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
Interventions
* 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
Eligibility Criteria
You may qualify if:
- Narcoleptic patients with cataplexy
You may not qualify if:
- Subjects not diagnosed with narcolepsy with cataplexy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharma SAlead
Study Sites (1)
Unknown Facility
Liège, Belgium
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 844 599 2273 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2006
First Posted
June 29, 2006
Study Start
April 10, 2006
Primary Completion
January 22, 2008
Study Completion
January 22, 2008
Last Updated
April 8, 2022
Results First Posted
April 8, 2022
Record last verified: 2022-02