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...
Date First Received: November 14, 2007
Last Updated: November 14, 2007
Verified by: University Health Network, Toronto, November 2007
Clinical Trial Phase: N/A | Start Date: February 2008
Overall Status: Not yet recruiting
Estimated Enrollment: 12
Brief Summary
Official Title: “Study of Verapamil in Refractory Catamenial Epilepsy”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: verapamil hyrochloride
- 80 mg daily by mouth, 5 days prior to menses for 3 months
Outcome Measures for this Clinical Trial
Primary Measures
- the percent reduction in seizure frequency
- Time Frame: 3 months
- Time Frame: 3 months
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 60 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University Health Network, Toronto
Overall Clinical Trial Officials and Contacts
Danielle Andrade, MD Principal Investigator College of Physicians and Surgeons of Ontario
Overall Contact: Nina Politzer, BScN 416 603-5800 nina.politzer@uhn.on.ca
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00559169
Study ID Number: UHN-TWH-VER-001
ClinicalTrials.gov Identifier: NCT00559169
Health Authority: Canada: Health Canada
Clinical Trials Authorship and Review
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