Verapamil and Catamenial Epilepsy

Catamenial Epilepsy Clinical Trial

Official title:

Study of Verapamil in Refractory Catamenial Epilepsy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00559169
• Other study ID #: UHN-TWH-VER-001
• Status: Withdrawn
• Phase: N/A
• First received: November 14, 2007
• Last updated: April 7, 2010
• Start date: February 2009
• Est. completion date: December 2010

Study information

• Verified date: November 2007
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 12
• Est. completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Catamenial Epilepsy
• Epilepsy

Intervention

Drug:
• verapamil hyrochloride
80 mg daily by mouth, 5 days prior to menses for 3 months

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percent reduction in seizure frequency		3 months