Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Dependence in Patients Who Received Xyrem ® on Prescription
- 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
- Patients who received Xyrem ® on prescription
- 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)
22
🇩🇪Bremen, Germany
4
🇮🇪Dublin 7, Ireland
24
🇩🇪Berlin, Germany
13
🇧🇪Brussels, Belgium
40
🇪🇸Baracaldo, Spain
26
🇬🇧Essex, United Kingdom
17
🇪🇸Castellon, Spain
31
🇩🇪Ulm, Germany
32
🇪🇸Granada, Spain
2
🇬🇧Cambridge, United Kingdom
29
🇪🇸Madrid, Spain
19
🇩🇪Hofheim/Taunus, Germany
36
🇪🇸San Sebastian, Spain
7
🇪🇸Barcelona, Spain
23
🇩🇪Münster, Germany
15
🇪🇸Madrid, Spain
11
🇪🇸Barcelona, Spain
1
🇩🇪Schwalmstadt, Germany
20
🇩🇪Regensburg, Germany
30
🇪🇸Vitoria, Spain
21
🇩🇪Westerstede, Germany
18
🇮🇹Bologna, Italy
27
🇬🇧Leicester, United Kingdom
14
🇪🇸Sevilla, Spain
34
🇧🇪Gent, Belgium
35
🇧🇪Leuven, Belgium
5
🇦🇹Innsbruck, Austria
28
🇧🇪Brugge, Belgium
33
🇨🇭Bern, Switzerland
12
🇧🇪Antwerpen, Belgium
41
🇨🇭Barmelweid, Switzerland
9
🇦🇹Graz, Austria
10
🇧🇪Liege, Belgium
16
🇨🇿Praha 2, Czech Republic
6
🇨🇭Zürich, Switzerland
25
🇩🇪Berlin, Germany
42
🇩🇪Katzenelnbogen, Germany
37
🇪🇸Sevilla, Spain
39
🇪🇸Palma de Mallorca, Spain
43
🇪🇸Vitoria, Spain
38
🇪🇸Vigo, Spain