NCT00559169

Brief Summary

One in 3 epilepsy patients have refractory seizures. This drug resistance is likely related to the over expression of multidrug resistance proteins (MDR). Progesterone is a known inhibitor of MDRs and the low level of this hormone during the menstrual cycle may exacerbate seizures, perhaps explaining catamenial epilepsy; i.e. seizures occurring during the menstrual cycle. Verapamil suppresses seizures in animal models of epilepsy perhaps by inhibiting MDRs and thus may help patients with refractory seizures. If the study shows improved seizure control, the results will help establish the role of MDRs in refractory epilepsy.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2007

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 8, 2010

Status Verified

November 1, 2007

First QC Date

November 14, 2007

Last Update Submit

April 7, 2010

Conditions

Catamenial Epilepsy

Keywords

epilepsyseizuresmenstrual cycle

Outcome Measures

Primary Outcomes (1)

  • the percent reduction in seizure frequency

    3 months

Interventions

verapamil hyrochlorideDRUG

80 mg daily by mouth, 5 days prior to menses for 3 months

Also known as: apo-verap, isoptin

Eligibility Criteria

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

You may qualify if:

  • females
  • at least 2 seizures per month
  • more than 50% of the seizures occur 7 days before or 7 days after the onset of menses
  • patient of the Toronto Western Hospital Epilepsy Clinic

You may not qualify if:

  • cardiovascular history

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

Study Officials

  • Danielle Andrade, MD

    College of Physicians and Surgeons of Ontario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 14, 2007

First Posted

November 16, 2007

Study Start

February 1, 2009

Study Completion

December 1, 2010

Last Updated

April 8, 2010

Record last verified: 2007-11

Locations

CA(1)