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Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Dependence in Patients Who Received Xyrem ® on Prescription

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ClinicalTrials.gov Identifier: NCT00244465
Recruitment Status : Completed
First Posted : October 26, 2005
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Narcolepsy

Study Type : Observational
Actual Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : May 2006
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Club Drugs




Primary Outcome Measures :
  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. [ Time Frame: 12 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients being treated with Xyrem®.
Criteria

Inclusion Criteria:

  • Patients who received Xyrem ® on prescription

Exclusion Criteria:

  • No limitations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00244465


  Hide Study Locations
Locations
Austria
9
Graz, Austria
5
Innsbruck, Austria
Belgium
12
Antwerpen, Belgium
28
Brugge, Belgium
13
Brussels, Belgium
34
Gent, Belgium
35
Leuven, Belgium
10
Liege, Belgium
Czech Republic
16
Praha 2, Czech Republic
Germany
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
Ireland
4
Dublin 7, Ireland
Italy
18
Bologna, Italy
Spain
40
Baracaldo, Spain
11
Barcelona, Spain
7
Barcelona, Spain
17
Castellon, Spain
32
Granada, Spain
15
Madrid, Spain
29
Madrid, Spain
39
Palma de Mallorca, Spain
36
San Sebastian, Spain
14
Sevilla, Spain
37
Sevilla, Spain
38
Vigo, Spain
30
Vitoria, Spain
43
Vitoria, Spain
Switzerland
41
Barmelweid, Switzerland
33
Bern, Switzerland
6
Zürich, Switzerland
United Kingdom
2
Cambridge, United Kingdom
26
Essex, United Kingdom
27
Leicester, United Kingdom
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Cares +1 877 822 9493 (UCB)

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00244465     History of Changes
Other Study ID Numbers: C00302
First Posted: October 26, 2005    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016

Keywords provided by UCB Pharma:
Narcolepsy
Cataplexy
Oxybate
Xyrem
Misuse
Safety

Additional relevant MeSH terms:
Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders