| DEC-NET Serial number ES544 |
| |
| Published online | 08/05/2006 8.57.00 |
| Last updated | 24/04/2006 9.12.28 |
| |
| Other protocol ID number | JAN-TOP-2003-01 |
| Current trial status | Open (actively recruiting new participants) |
Major Disease
(ICD9 class) | Epilepsy |
| Experimental drug |
Topiramate
Treatment regimen (dosage and duration)
|
| Gender | Both |
| Age (range) | >11 years |
Eligibility criteria |
| Inclusion criteria |
| Epilepsy of any cause treated with topiramate in monotherapy as the labelling conditions |
| Exclusion criteria |
| Hypersensitive to active or other components of the product |
Trial design/methodology |
| Phase | 4 |
| Kind of study | Safety
|
| Design | Observacional |
| Purpose of study |
| To evaluate tolerability and safety of topiramate in monotherapy in patients with epilepsy in clinical practice |
| Primary outcomes |
| Adverse events /toxicity |
| Secondary outcomes |
| Effectiveness (convulsive crisis, treatment adherence and global clinical improvement) |
| Summary of study design, objectives, and ongoing research findings |
| Multicentre, observational, prospective and open-label study to evaluate tolerability and safety of topiramate in monotherapy in patients with epilepsy in clinical practice. |
