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


Brief 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.

Intervention / Treatment

Condition or Disease

  • Narcolepsy


Study Design

Status: Completed
Study results: No Results Available
Age: Child, Adult, Older Adult
Enrollment: 750 (ACTUAL)
Funded by: Industry
Time Perspective: Prospective
Observational Model: Cohort


Clinical Trial Dates

Start date: May 01, 2006
Primary Completion: Sep 01, 2016 ACTUAL
Completion Date: Sep 01, 2016 ACTUAL
Study First Posted: Oct 26, 2005 ESTIMATED
Results First Posted: Aug 30, 2020
Last Updated: Sep 05, 2016

Sponsors / Collaborators

Lead Sponsor: UCB Pharma
Lead sponsor is responsible party
Responsible Party: N/A

Eligibility Criteria

Sex: All
Age Groups: Child / Adult / Older Adult
Healthy Volunteers: Yes

Inclusion Criteria:

* Patients who received Xyrem ® on prescription

Exclusion Criteria:

* No limitations

Primary Outcomes
  • 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

More Details

NCT Number: NCT00244465
Other IDs: C00302
Study URL: https://clinicaltrials.gov/study/NCT00244465
Last updated: Sep 29, 2023