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Study of Verapamil in Refractory Epilepsy

Primary Purpose

Epilepsy, Seizures

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Verapamil
placebo
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring refractory epilepsy- greater than 4 seizures in 2 month baseline period

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

verapamil

placebo sugar pill

Arm Description

verapamil 80mg tid

placebo tid

Outcomes

Primary Outcome Measures

percentage reduction of seizure frequency
after 3 months of treartment compared to baseline

Secondary Outcome Measures

Full Information

First Posted
May 17, 2010
Last Updated
May 18, 2010
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01126307
Brief Title
Study of Verapamil in Refractory Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Seizures
Keywords
refractory epilepsy- greater than 4 seizures in 2 month baseline period

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
verapamil
Arm Type
Active Comparator
Arm Description
verapamil 80mg tid
Arm Title
placebo sugar pill
Arm Type
Placebo Comparator
Arm Description
placebo tid
Intervention Type
Drug
Intervention Name(s)
Verapamil
Other Intervention Name(s)
Isoptin
Intervention Description
80 mg tid
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo tid
Primary Outcome Measure Information:
Title
percentage reduction of seizure frequency
Description
after 3 months of treartment compared to baseline
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Politzer, BScN
Phone
416 603-5800
Ext
2446
Email
nina.politzer@uhn.on.ca
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

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Study of Verapamil in Refractory Epilepsy

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