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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

May 17, 2010
May 18, 2010
June 2010
December 2012   (final data collection date for primary outcome measure)
percentage reduction of seizure frequency [ Time Frame: 3 months ] [ Designated as safety issue: No ]
after 3 months of treartment compared to baseline
Same as current
Complete list of historical versions of study NCT01126307 on ClinicalTrials.gov Archive Site
Not Provided
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Study of Verapamil in Refractory Epilepsy
Not Provided

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Epilepsy
  • Seizures
  • Drug: Verapamil
    80 mg tid
    Other Name: Isoptin
  • Drug: placebo
    placebo tid
  • Active Comparator: verapamil
    verapamil 80mg tid
    Intervention: Drug: Verapamil
  • Placebo Comparator: placebo sugar pill
    placebo tid
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
16
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Nina Politzer, BScN 416 603-5800 ext 2446 nina.politzer@uhn.on.ca
Canada
 
NCT01126307
UHN REB # 10-0024-A
No
Dr. Danielle Andrade, Toronto Western Hospital
University Health Network, Toronto
Not Provided
Not Provided
University Health Network, Toronto
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP