Study of Verapamil in Refractory Epilepsy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University Health Network, Toronto.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01126307
First received: May 17, 2010
Last updated: May 18, 2010
Last verified: March 2010
  Purpose

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


Condition Intervention
Epilepsy
Seizures
Drug: Verapamil
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • percentage reduction of seizure frequency [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    after 3 months of treartment compared to baseline


Estimated Enrollment: 16
Study Start Date: June 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: verapamil
verapamil 80mg tid
Drug: Verapamil
80 mg tid
Other Name: Isoptin
Placebo Comparator: placebo sugar pill
placebo tid
Drug: placebo
placebo tid

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126307

Contacts
Contact: Nina Politzer, BScN 416 603-5800 ext 2446 nina.politzer@uhn.on.ca

Locations
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Dr. Danielle Andrade, Toronto Western Hospital
ClinicalTrials.gov Identifier: NCT01126307     History of Changes
Other Study ID Numbers: UHN REB # 10-0024-A
Study First Received: May 17, 2010
Last Updated: May 18, 2010
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
refractory epilepsy- greater than 4 seizures in 2 month baseline period

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Verapamil
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on October 16, 2014