Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Dependence in Patients Who Received Xyrem ® on Prescription
Completed
- Conditions
- Narcolepsy
- Registration Number
- NCT00244465
- Lead Sponsor
- UCB Pharma
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 750
Inclusion Criteria
- Patients who received Xyrem ® on prescription
Exclusion Criteria
- No limitations
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of risk for development adverse events, withdrawal syndrome and potential for dependence, abuse, overdose and misuse of Xyrem®. Obtaining information about adherence to Xyrem® prescribing information regarding indication and dosage. 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
9
🇦🇹Graz, Austria
5
🇦🇹Innsbruck, Austria
12
🇧🇪Antwerpen, Belgium
28
🇧🇪Brugge, Belgium
13
🇧🇪Brussels, Belgium
34
🇧🇪Gent, Belgium
35
🇧🇪Leuven, Belgium
10
🇧🇪Liege, Belgium
16
🇨🇿Praha 2, Czech Republic
24
🇩🇪Berlin, Germany
Scroll for more (31 remaining)9🇦🇹Graz, Austria