- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00559169
Verapamil and Catamenial Epilepsy
April 7, 2010 updated by: University Health Network, Toronto
Study of Verapamil in Refractory Catamenial Epilepsy
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 Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5T 2S8
- Toronto Western Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the percent reduction in seizure frequency
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Danielle Andrade, MD, College of Physicians and Surgeons of Ontario
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Study Completion (Anticipated)
December 1, 2010
Study Registration Dates
First Submitted
November 14, 2007
First Submitted That Met QC Criteria
November 14, 2007
First Posted (Estimate)
November 16, 2007
Study Record Updates
Last Update Posted (Estimate)
April 8, 2010
Last Update Submitted That Met QC Criteria
April 7, 2010
Last Verified
November 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Epilepsy
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Verapamil
Other Study ID Numbers
- UHN-TWH-VER-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Catamenial Epilepsy
-
University of FloridaEisai Inc.Recruiting
-
Marinus PharmaceuticalsCompletedPartial Epilepsy | Catamenial EpilepsyUnited States
-
Johns Hopkins UniversityVitaflo International, LtdCompletedEpilepsy | Seizure | Catamenial Epilepsy | Medically Resistant Epilepsy | Medically Resistant SeizuresUnited States
-
NaviFUS CorporationTaipei Veterans General Hospital, TaiwanCompletedDrug Resistant Epilepsy | Epilepsy, Drug Resistant | Intractable Epilepsy | Refractory Epilepsy | Drug Refractory Epilepsy | Epilepsy, Drug Refractory | Epilepsy, Intractable | Medication Resistant EpilepsyTaiwan
-
Great Ormond Street Hospital for Children NHS Foundation...Active, not recruitingEpilepsies, Partial | Intractable Epilepsy | Focal Epilepsy | Refractory Epilepsy | Epilepsy Intractable | Epilepsy in Children | Epilepsy, FocalUnited Kingdom
-
University of British ColumbiaTerminatedJuvenile Myoclonic Epilepsy | Childhood Absence Epilepsy | Juvenile Absence EpilepsyCanada
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruiting
-
Neuroelectrics CorporationRecruitingEpilepsy | Seizures | Refractory Epilepsy | Epilepsy, Tonic-Clonic | Epilepsy in Children | Seizures, Focal | Focal SeizureSpain, United States, France, Belgium
-
Oslo University HospitalCompletedEpilepsy | Generalized Epilepsy | Focal EpilepsyNorway
-
UCB Pharma SACompletedEpilepsy, Tonic-clonicPoland, Sweden, Hungary, Czechia
Clinical Trials on verapamil hyrochloride
-
Synerx Pharma, LLCCompleted
-
Bristol-Myers SquibbCompleted
-
University of PittsburghNational Institute of Mental Health (NIMH)Completed
-
60 Degrees Pharmaceuticals LLCNot yet recruiting
-
Benjamin BleierTerminated
-
Medical University of GrazJuvenile Diabetes Research FoundationRecruitingDiabetes Mellitus, Type 1United Kingdom, Belgium, Poland, Austria, France, Germany, Italy
-
Center Laboratories, Inc.TerminatedEpisodic Cluster HeadacheUnited Kingdom
-
AbbottCompletedHypertension | Diabetes
-
Shandong Suncadia Medicine Co., Ltd.Not yet recruitingObstructive Hypertrophic Cardiomyopathy