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.
Study Design
| Study type: | OBSERVATIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | Child, Adult, Older Adult |
| Enrollment: | 750 (ACTUAL) |
| Funded by: | Industry |
| Time Perspective: | Prospective |
| Observational Model: | Cohort |
Masking |
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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
Location
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
* Patients who received Xyrem ® on prescription
Exclusion Criteria:
* No limitations
Primary Outcomes
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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