Verapamil and Catamenial Epilepsy

This study has been withdrawn prior to enrollment.
(protocol changed and a new study using verapamil in epilepsy will be started in the near future)
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00559169
First received: November 14, 2007
Last updated: April 7, 2010
Last verified: November 2007
  Purpose

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.


Condition Intervention
Catamenial Epilepsy
Drug: verapamil hyrochloride

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Verapamil in Refractory Catamenial Epilepsy

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • the percent reduction in seizure frequency [ Time Frame: 3 months ]

Estimated Enrollment: 12
Study Start Date: February 2009
Estimated Study Completion Date: December 2010
Intervention Details:
    Drug: verapamil hyrochloride
    80 mg daily by mouth, 5 days prior to menses for 3 months
    Other Name: apo-verap, isoptin
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559169

Locations
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Danielle Andrade, MD College of Physicians and Surgeons of Ontario
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00559169     History of Changes
Other Study ID Numbers: UHN-TWH-VER-001
Study First Received: November 14, 2007
Last Updated: April 7, 2010
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
epilepsy
seizures
menstrual cycle

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Verapamil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014