Study of Verapamil in Refractory Epilepsy

University Health Network, Toronto

Status: Unknown

Conditions: Seizures; Epilepsy

Treatments: Drug: Verapamil; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01126307

UHN REB # 10-0024-A

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

16 participants in 2 patient groups, including a placebo group

verapamil

Active Comparator group

Description:

verapamil 80mg tid

Treatment:

Drug: Verapamil

placebo sugar pill

Placebo Comparator group

Description:

placebo tid

Treatment:

Drug: placebo