- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01126307
Study of Verapamil in Refractory Epilepsy
May 18, 2010 updated by: University Health Network, Toronto
Epilepsy is one of the most common chronic neurological diseases, affecting 300,000 Canadians.
One in 3 epilepsy patients have refractory seizures meaning that all antiseizure drugs fail to control their seizures.
This drug resistance in epilepsy may be related to the over expression of multidrug resistance proteins (MDR).
Varapamil inhibits MDR.
We propose to add verapamil/placebo to patients' anti epilepsy medication for 3 months.
Patients who receive placebo will have verapamil added for 3 months after the completion of the double-blind treatment period.
Seizure frequency/severity will be tracked.
Blood samples for DNA will be collected.
There will be 9 clinic visits over 32 weeks.
ECG and echocardiogram will be done at baseline and repeated if necessary
Study Overview
Detailed Description
This open label study will consist of three phases: baseline, Double-blind treatment and open-label-treatment.
There are 9 visits over 32 weeks.
During the baseline period, the number of seizures will be recorded during 2 months while the patient is on a dose of antiseizure drug(s) that was previously established to provide better seizure control.
Blood work, including blood for DNA baseline ECG and echocardiogram will be done and may be repeated if necessary.
During the 3 months of double-blind treatment phase, verapamil/placebo will be added to the current medications.
Visits are every 4 weeks.
Vital signs, seizure counts and adverse events will be evaluated.
All patients who received placebo will be offered 3 months of open-label treatment with verapamil.
Study Type
Interventional
Enrollment (Anticipated)
16
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
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Ontario
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Toronto, Ontario, Canada, M5T 2S8
- Toronto Western Hospital
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-
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
16 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 1. patients in whom seizures are not controlled by their antiseizure medication;
- 2. must have at least 2 seizures per month.
Exclusion Criteria:
- Exclusion: patients with cardiovascular problems that could be adversely affected by verapamil
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: verapamil
verapamil 80mg tid
|
80 mg tid
Other Names:
|
Placebo Comparator: placebo sugar pill
placebo tid
|
placebo tid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percentage reduction of seizure frequency
Time Frame: 3 months
|
after 3 months of treartment compared to baseline
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
June 1, 2010
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
May 17, 2010
First Submitted That Met QC Criteria
May 18, 2010
First Posted (Estimate)
May 19, 2010
Study Record Updates
Last Update Posted (Estimate)
May 19, 2010
Last Update Submitted That Met QC Criteria
May 18, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Epilepsy
- Seizures
- 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 REB # 10-0024-A
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.
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