Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Dependence in Patients Who Received Xyrem ® on Prescription
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.
1 other identifier
observational
750
9 countries
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2006
Longer than P75 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2005
CompletedFirst Posted
Study publicly available on registry
October 26, 2005
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedSeptember 7, 2016
September 1, 2016
10.3 years
October 24, 2005
September 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
Patients being treated with Xyrem®.
You may qualify if:
- Patients who received Xyrem ® on prescription
You may not qualify if:
- No limitations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (41)
9
Graz, Austria
5
Innsbruck, Austria
12
Antwerp, Belgium
28
Bruges, Belgium
13
Brussels, Belgium
34
Ghent, Belgium
35
Leuven, Belgium
10
Liège, Belgium
16
Prague, Czechia
24
Berlin, Germany
25
Berlin, Germany
22
Bremen, Germany
19
Hofheim/Taunus, Germany
42
Katzenelnbogen, Germany
23
Münster, Germany
20
Regensburg, Germany
1
Schwalmstadt, Germany
31
Ulm, Germany
21
Westerstede, Germany
4
Dublin, Ireland
18
Bologna, Italy
40
Barakaldo, Spain
11
Barcelona, Spain
7
Barcelona, Spain
17
Castellon, Spain
36
Donostia / San Sebastian, Spain
32
Granada, Spain
15
Madrid, Spain
29
Madrid, Spain
39
Palma de Mallorca, Spain
14
Seville, Spain
37
Seville, Spain
38
Vigo, Spain
30
Vitoria-Gasteiz, Spain
43
Vitoria-Gasteiz, Spain
41
Barmelweid, Switzerland
33
Bern, Switzerland
6
Zurich, Switzerland
2
Cambridge, United Kingdom
26
Essex, United Kingdom
27
Leicester, United Kingdom
Related Publications (1)
Mayer G, Plazzi G, Iranzo A, Ortega-Albas J, Quinnell T, Pesch H, Serralheiro P, Schlit AF, Wuiame D, Bentz JWG. Long-term compliance, safety, and tolerability of sodium oxybate treatment in patients with narcolepsy type 1: a postauthorization, noninterventional surveillance study. Sleep. 2018 Sep 1;41(9). doi: 10.1093/sleep/zsy128.
PMID: 29986085DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 877 822 9493 (UCB)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2005
First Posted
October 26, 2005
Study Start
May 1, 2006
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
September 7, 2016
Record last verified: 2016-09