Verapamil and Catamenial Epilepsy

NCT ID: NCT00559169

Last Updated: 2010-04-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-12-31

Brief Summary

One in 3 epilepsy patients have refractory seizures. This drug resistance is likely related to the over expression of multidrug resistance proteins (MDR). Progesterone is a known inhibitor of MDRs and the low level of this hormone during the menstrual cycle may exacerbate seizures, perhaps explaining catamenial epilepsy; i.e. seizures occurring during the menstrual cycle. Verapamil suppresses seizures in animal models of epilepsy perhaps by inhibiting MDRs and thus may help patients with refractory seizures. If the study shows improved seizure control, the results will help establish the role of MDRs in refractory epilepsy.

Conditions

Catamenial Epilepsy

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

verapamil hyrochloride

80 mg daily by mouth, 5 days prior to menses for 3 months

Intervention Type: DRUG

Other Intervention Names

apo-verap, isoptin

Eligibility Criteria

Inclusion Criteria

• females
• at least 2 seizures per month
• more than 50% of the seizures occur 7 days before or 7 days after the onset of menses
• patient of the Toronto Western Hospital Epilepsy Clinic

Exclusion Criteria

• cardiovascular history

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

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Principal Investigators

Danielle Andrade, MD

Role: PRINCIPAL_INVESTIGATOR

College of Physicians and Surgeons of Ontario

Locations

Toronto Western Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN-TWH-VER-001

Identifier Type: -

Identifier Source: org_study_id