Verapamil and Catamenial Epilepsy

This study is not yet open for participant recruitment.

Verified by University Health Network, Toronto, November 2007

First Received: November 14, 2007 No Changes Posted

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:	Treatment, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
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 2008
Estimated Study Completion Date:	December 2010

Intervention Details:

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

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

Contacts

Contact: Nina Politzer, BScN	416 603-5800 ext 2446	nina.politzer@uhn.on.ca
Contact: Danielle Andrade, MD	416 603-5927	danielle.andrade@uhn.on.ca

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

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

Keywords provided by University Health Network, Toronto:

epilepsy
seizures
menstrual cycle

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Central Nervous System Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents
Brain Diseases

Pharmacologic Actions
Membrane Transport Modulators
Verapamil
Epilepsy
Therapeutic Uses
Diltiazem
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on November 09, 2009