Phase 4
Completed N=55
First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients
Source: ClinicalTrials.gov NCT01627860 ↗Enrolled (actual)
55
Serious AEs
3.6%
Results posted
May 2013
Primary outcomePrimary: Seizure Free Rate: Percentage of Participants Who Did Not Have Any Seizure Episode Within the Last Month of the Maintenance Period (ie, Month 4). — 88.57; 65.00 Percentage of participants — p=0.0759
Summary
The purpose of this study is to examine seizure control and tolerability of Topiramate after either transitioning from previous antiepileptic drug (AED) or adding on to previous AED.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seizure Free Rate: Percentage of Participants Who Did Not Have Any Seizure Episode Within the Last Month of the Maintenance Period (ie, Month 4). |
88.57; 65.00 | 0.0759 |
| SECONDARY Seizure Frequency: Percent Change of Seizure Frequency by the ANCOVA Model During the Month 4 |
-55.3; -75.8 | 0.7102 |
| SECONDARY Dosage Administration of Topamax During Month 4 |
182.46; 178.57 | — |
Eligibility Criteria
Inclusion Criteria
- Must be diagnosed with seizure disorder
- Have been receiving concomitant therapy with one antiepileptic drug (AED), at stable dose prior to trial entry
- Must be dissatisfied with the current treatment
Exclusion Criteria
- Have treatable cause of seizures (eg, metabolic disturbance, toxic exposure, an active infection, or neoplasm)
- Have grade IV astrocytomas, eg, Glioblastoma multiforme (GBM) or metastases with progression
- Have seizures occurring only in clustered patterns defined as numerous seizures occurring in less than 30 min
- Have had history (within past six months) of a psychiatric or mood disorder requiring electroconvulsive therapy, major tranquilizers, or monoamine oxidase inhibitors
- Have had schizophrenic or history of exhibiting psychotic symptomatology
- Inability to take medication or maintain a seizure calendar, independently or with assistance
Data sourced from ClinicalTrials.gov (NCT01627860). 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.