Study of Verapamil in Refractory Epilepsy

NCT ID: NCT01126307

Last Updated: 2010-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-12-31

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.

Conditions

Epilepsy; Seizures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

verapamil

verapamil 80mg tid

Group Type: ACTIVE_COMPARATOR

Verapamil

Intervention Type: DRUG

80 mg tid

placebo sugar pill

placebo tid

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo tid

Interventions

Verapamil

80 mg tid

Intervention Type: DRUG

placebo

placebo tid

Intervention Type: DRUG

Other Intervention Names

Isoptin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Toronto Western Hospital

Locations

Toronto Western Hospital

Toronto, Ontario, Canada

Countries

Canada

Central Contacts

Nina Politzer, BScN

Role: CONTACT

nina.politzer@uhn.on.ca

416 603-5800 ext. 2446

Other Identifiers

UHN REB # 10-0024-A

Identifier Type: -

Identifier Source: org_study_id