Back to resultsVerapamil and Catamenial Epilepsy
Primary Purpose
Catamenial Epilepsy
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
verapamil hyrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Catamenial Epilepsy focused on measuring epilepsy, seizures, menstrual cycle
Eligibility 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
Sites / Locations
- Toronto Western Hospital
Outcomes
Primary Outcome Measures
the percent reduction in seizure frequency
Secondary Outcome Measures
Full Information
NCT ID
NCT00559169
First Posted
November 14, 2007
Last Updated
April 7, 2010
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT00559169
Brief Title
Verapamil and Catamenial Epilepsy
Official Title
Study of Verapamil in Refractory Catamenial Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Withdrawn
Why Stopped
protocol changed and a new study using verapamil in epilepsy will be started in the near future
Study Start Date
February 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catamenial Epilepsy
Keywords
epilepsy, seizures, menstrual cycle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
verapamil hyrochloride
Other Intervention Name(s)
apo-verap, isoptin
Intervention Description
80 mg daily by mouth, 5 days prior to menses for 3 months
Primary Outcome Measure Information:
Title
the percent reduction in seizure frequency
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Andrade, MD
Organizational Affiliation
College of Physicians and Surgeons of Ontario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Verapamil and Catamenial Epilepsy
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