Overview

This trial is active, not recruiting.

Condition narcolepsy
Phase phase 4
Sponsor UCB Pharma
Start date May 2006
End date August 2017
Trial size 750 participants
Trial identifier NCT00244465, C00302

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients who received Xyrem ® on prescription Exclusion Criteria: - No limitations

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by UCB Pharma.