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Study of Verapamil in Refractory Epilepsy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01126307
Enrollment
16
Registered
2010-05-19
Start date
2010-06-30
Completion date
2012-12-31
Last updated
2010-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Seizures

Keywords

refractory epilepsy- greater than 4 seizures in 2 month baseline period

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.

Interventions

DRUGVerapamil

80 mg tid

DRUGplacebo

placebo tid

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
percentage reduction of seizure frequency3 monthsafter 3 months of treartment compared to baseline

Countries

Canada

Contacts

Primary ContactNina Politzer, BScN
nina.politzer@uhn.on.ca416 603-5800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026