Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Dependence in Patients Who Received Xyrem ® on Prescription | Not Recruiting
Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Dependence in Patients Who Received Xyrem ® on Prescription

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Narcolepsy
Unfortunately contact details are not available for this trial.
Primary Contact Details
Not Recruiting
Recruitment Status
NCT00244465
Primary Trial ID Number
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.
Research Details
    Sorry, this information is not available
Phase
Phase 4
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Study Type
Observational
Intervention
Sorry, this information is not available
Intervention Type
See Interventions above
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.; 12 months
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
N/A - N/A
Who Can Participate
Patients
Number of Participants
750
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Patients who received Xyrem ® on prescription
  • Exclusion Criteria:
  • - No limitations
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Leicester
Cambridge
26
Essex
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Austria, Belgium, Czech Republic, Germany, Ireland, Italy, Spain, Switzerland, United Kingdom
Scientific 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.
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
C00302
Sponsor(s)
UCB Pharma
Key Dates

Recruitment Start Date

May 2006

Recruitment End Date

Aug 2017

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

24 Oct 2005

Last Updated

30 Jun 2015