Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244465
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2005-10-24
Brief Title:
Observational Study to Evaluate Risks of Side Effects Drug Abuse and Dependence in Patients Who Received Xyrem on Prescription
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
Post Marketing Non-interventional Surveillance Pharmacoepidemiology Study PMSS to Evaluate Long-term Safety Tolerability and Compliance in Administration of Xyrem Sodium Oxybate Oral Solution in Patients Who Receive Treatment With This Medication in Regular Clinical Practice
Status:
COMPLETED
Status Verified Date:
2016-09
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:
Patients will be followed up for max 18 months Information on the Adverse Events and potential misuse or abuse of Xyrem will be collected
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