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

This study is not yet open for patient recruitment.
Verified by UCB Pharma October 2005

Sponsored by: UCB Pharma
Information provided by: UCB Pharma
ClinicalTrials.gov Identifier: NCT00244465

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 IV

MedlinePlus related topics:  Sleep Disorders

Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study

Official Title: Post-Marketing Non-Interventional Pharmacoepidemiology Study to Evaluate Long-Term Safety, Tolerability and Compliance in Administration of Xyrem ® (Sodium Oxybate) in Regular Clinical Practice

Further study details as provided by UCB Pharma:

Expected Total Enrollment:  1000

Study start: March 2006

Eligibility

Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Patient s who received Xyrem ® on prescription

Exclusion Criteria:

  • No limitations

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00244465

UCB - Clinical Trial Call Center      +1 877 822 9493 

Study chairs or principal investigators

Sonja Buyle, MD,  Study Director,  UCB Pharma   

More Information

Study ID Numbers:  C00302
Last Updated:  December 8, 2005
Record first received:  October 24, 2005
ClinicalTrials.gov Identifier:  NCT00244465
Health Authority: European Union: European Medicines Agency
ClinicalTrials.gov processed this record on 2006-01-10

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