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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00244465
First Posted: October 26, 2005
Last Update Posted: September 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma
  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 Pharma:

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 ]

Enrollment: 750
Study Start Date: May 2006
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
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


  Show 41 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Cares +1 877 822 9493 (UCB)
  More Information

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00244465     History of Changes
Other Study ID Numbers: C00302
First Submitted: October 24, 2005
First Posted: October 26, 2005
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