Verapamil and Catamenial Epilepsy

April 7, 2010 updated by: University Health Network, Toronto

Study of Verapamil in Refractory Catamenial Epilepsy

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the percent reduction in seizure frequency
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Danielle Andrade, MD, College of Physicians and Surgeons of Ontario

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

November 14, 2007

First Submitted That Met QC Criteria

November 14, 2007

First Posted (Estimate)

November 16, 2007

Study Record Updates

Last Update Posted (Estimate)

April 8, 2010

Last Update Submitted That Met QC Criteria

April 7, 2010

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN-TWH-VER-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Catamenial Epilepsy

Clinical Trials on verapamil hyrochloride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe