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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00244465
First received: October 24, 2005
Last updated: July 4, 2014
Last verified: July 2014
  Purpose

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 Phase
Narcolepsy
Phase 4

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: May 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
7
Barcelona, Spain
11
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
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, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00244465     History of Changes
Other Study ID Numbers: C00302
Study First Received: October 24, 2005
Last Updated: July 4, 2014
Health Authority: European Union: European Medicines Agency

Keywords provided by UCB, Inc.:
Narcolepsy
Cataplexy
Oxybate
Xyrem
Misuse
Safety

Additional relevant MeSH terms:
Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Sodium Oxybate
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014