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This study has been withdrawn prior to enrollment.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 )

First Received on November 14, 2007. Last Updated on April 7, 2010 History of Changes

Sponsor:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00559169

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:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Menstruation Seizures

Drug Information available for: Verapamil Diltiazem hydrochloride Dexverapamil Diltiazem Diltiazem malate Verapamil hydrochloride

U.S. FDA Resources

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:

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

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
Diltiazem
Vasodilator Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents

ClinicalTrials.gov processed this record on February 13, 2012