Study of Verapamil in Refractory Epilepsy

Not Applicable

• Conditions: Seizures; Epilepsy
• Interventions: Drug: Verapamil; Drug: placebo

• Registration Number: NCT01126307
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Status Verified: 2010-03
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-18
• Last Update Submitted: 2010-05-18
• Study First Posted: 2010-05-19
• Last Update Posted: 2010-05-19
• Study Start: 2010-06
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
verapamil	Verapamil	verapamil 80mg tid
placebo sugar pill	placebo	placebo tid

Primary Outcome Measures

Name	Time	Method
percentage reduction of seizure frequency	3 months	after 3 months of treartment compared to baseline

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada