NCT01126307

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2010

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 19, 2010

Status Verified

March 1, 2010

Enrollment Period

2.5 years

First QC Date

May 17, 2010

Last Update Submit

May 18, 2010

Conditions

EpilepsySeizures

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • percentage reduction of seizure frequency

    after 3 months of treartment compared to baseline

    3 months

Study Arms (2)

verapamil

ACTIVE COMPARATOR

verapamil 80mg tid

Drug: Verapamil

placebo sugar pill

PLACEBO COMPARATOR

placebo tid

Drug: placebo

Interventions

VerapamilDRUG

80 mg tid

Also known as: Isoptin
verapamil
placeboDRUG

placebo tid

placebo sugar pill

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. patients in whom seizures are not controlled by their antiseizure medication;
  • \. must have at least 2 seizures per month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

EpilepsySeizures

Interventions

Verapamil

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic Chemicals

Central Study Contacts

Nina Politzer, BScN

CONTACT

416 603-5800nina.politzer@uhn.on.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 17, 2010

First Posted

May 19, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 19, 2010

Record last verified: 2010-03

Locations

CA(1)