N/A
Completed N=1,234
An Observational Study to Evaluate Long-term Retention Rate of Topiramate in Participants With Epilepsy
Source: ClinicalTrials.gov NCT01682681 ↗Enrolled (actual)
1,234
Serious AEs
0.7%
Results posted
Aug 2013
Primary outcomePrimary: Percentage of Participants Retained to Topiramate Treatment — 71.56 Percentage of participants
Summary
The purpose of this study is to evaluate the long-term retention rate of topiramate in participants with epilepsy (seizure disorder).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Retained to Topiramate Treatment |
71.56 | — |
| SECONDARY Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs) |
749 | — |
| SECONDARY Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy |
507; 64; 661 | — |
| SECONDARY Percentage of Participants Without Seizure |
40.50 | — |
| SECONDARY Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More |
84.20 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with all type of epilepsy
- Participants with more than 2 episodes of seizure during last 1 year
- Participants who can comply with the visit schedule and are willing and able to complete evaluation procedures specified in the protocol during the treatment period
- Female participants with child bearing potential and who use proper contraceptive methods during the study period
Exclusion Criteria
- Participants who have known hypersensitivity reaction or allergy to the study drug
- Participants who have taken topiramate within the three months of study start
- Participants who are determined not to be suitable for the clinical study participation by an Investigator's discretion
- Pregnant and nursing female participants
Data sourced from ClinicalTrials.gov (NCT01682681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.