Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345800
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2006-06-28
Brief Title:
Exploratory Clinical Study to Evaluate Sodium Oxybate Xyrem on Potential Endocrine Changes
Sponsor:
UCB Pharma SA
Organization:
UCB Pharma
Study Overview
Official Title:
Single Center Therapeutic Exploratory Clinical Trial to Evaluate the Safety of Sodium Oxybate Xyrem 500 mgmL Oral Solution on Potential Endocrine Changes at Currently Labeled Therapeutic Dose Regimens 45 - 9 gDay Divided Into Two Equal Doses During 12 Weeks of Treatment of Cataplexy in Adult Patients With Narcolepsy
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-004417-15 | EUDRACT_NUMBER | None | None |