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Verapamil and Catamenial Epilepsy

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ClinicalTrials.gov Identifier: NCT00559169
Recruitment Status : Withdrawn (protocol changed and a new study using verapamil in epilepsy will be started in the near future)
First Posted : November 16, 2007
Last Update Posted : April 8, 2010
Sponsor:
Information provided by:
University Health Network, Toronto

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2009
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures


Intervention Details:
  • Drug: verapamil hyrochloride
    80 mg daily by mouth, 5 days prior to menses for 3 months
    Other Name: apo-verap, isoptin


Primary Outcome Measures :
  1. the percent reduction in seizure frequency [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559169


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

ClinicalTrials.gov Identifier: NCT00559169     History of Changes
Other Study ID Numbers: UHN-TWH-VER-001
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: April 8, 2010
Last Verified: November 2007

Keywords provided by University Health Network, Toronto:
epilepsy
seizures
menstrual cycle

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Verapamil
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents