MedPath

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
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Exclusion Criteria
  • No limitations
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod

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

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