Epilepsy, Seizures
Conditions
Keywords
refractory epilepsy- greater than 4 seizures in 2 month baseline period
Brief summary
Epilepsy is one of the most common chronic neurological diseases, affecting 300,000 Canadians. One in 3 epilepsy patients have refractory seizures meaning that all antiseizure drugs fail to control their seizures. This drug resistance in epilepsy may be related to the over expression of multidrug resistance proteins (MDR). Varapamil inhibits MDR. We propose to add verapamil/placebo to patients' anti epilepsy medication for 3 months. Patients who receive placebo will have verapamil added for 3 months after the completion of the double-blind treatment period. Seizure frequency/severity will be tracked. Blood samples for DNA will be collected. There will be 9 clinic visits over 32 weeks. ECG and echocardiogram will be done at baseline and repeated if necessary
Detailed description
This open label study will consist of three phases: baseline, Double-blind treatment and open-label-treatment. There are 9 visits over 32 weeks. During the baseline period, the number of seizures will be recorded during 2 months while the patient is on a dose of antiseizure drug(s) that was previously established to provide better seizure control. Blood work, including blood for DNA baseline ECG and echocardiogram will be done and may be repeated if necessary. During the 3 months of double-blind treatment phase, verapamil/placebo will be added to the current medications. Visits are every 4 weeks. Vital signs, seizure counts and adverse events will be evaluated. All patients who received placebo will be offered 3 months of open-label treatment with verapamil.
Interventions
80 mg tid
placebo tid
Sponsors
Study design
Eligibility
Inclusion criteria
* 1\. patients in whom seizures are not controlled by their antiseizure medication; * 2\. must have at least 2 seizures per month.
Exclusion criteria
* Exclusion: patients with cardiovascular problems that could be adversely affected by verapamil
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage reduction of seizure frequency | 3 months | after 3 months of treartment compared to baseline |
Countries
Canada