Verapamil and Catamenial Epilepsy | NCT00559169

Studies
Verapamil and Catamenial Epilepsy

NCT00559169

Sponsor

University Health Network, Toronto

Status

Withdrawn

Last Update Posted

Apr 8, 2010Estimated

Enrollment

12Estimated

Phase

Not Applicable

Conditions

Catamenial Epilepsy

Interventions

verapamil hyrochloride

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

protocol changed and a new study using verapamil in epilepsy will be started in the near future

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Not provided

Completion Date

Dec 2010Estimated

First Submitted Date

Nov 14, 2007

First Submission Date that Met QC Criteria

Nov 14, 2007

First Posted Date

Nov 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2010

Last Update Posted Date

Apr 8, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
verapamil hyrochloride	Drug	80 mg daily by mouth, 5 days prior to menses for 3 months		apo-verap, isoptin

Measure	Description	Time Frame
the percent reduction in seizure frequency		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

cardiovascular history

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Danielle Andrade, MD	College of Physicians and Surgeons of Ontario	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Toronto Western Hospital		Toronto	Ontario	M5T 2S8	Canada

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy
D012640	Seizures

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014700	Verapamil

Ancestor Terms

ID	Term
D010627	Phenethylamines
D005021	Ethylamines
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided