Verapamil and Catamenial Epilepsy

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00559169
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Duration (Months): 21.9
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Catamenial Epilepsy	Drug: verapamil hyrochloride	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study of Verapamil in Refractory Catamenial Epilepsy
• Study Start Date: Feb 1, 2009
• Anticipated Study Completion Date: Dec 1, 2010

Outcome Measures

Primary Outcome Measures

1. the percent reduction in seizure frequency [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00559169
• Other Study ID Numbers: UHN-TWH-VER-001
• First Posted: Nov 16, 2007
• Last Update Posted: Apr 8, 2010
• Last Verified: Nov 1, 2007

• Keywords provided by , ,: epilepsy; seizures; menstrual cycle
• Additional relevant MeSH terms: Epilepsy; Verapamil

Study Results

No Results Posted as of Apr 8, 2010