A Study to Look at Antiepileptic Drug Levels While on Lamictal or Depakote With or Without an Oral Contraceptive

NCT ID: NCT00296413

Last Updated: 2017-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-02-28

Brief Summary

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Some antiseizure medication levels are affected by hormones. This study is being done to determine if blood levels of lamotrigine or valproate are affected by the hormones in the birth control pill or the menstrual cycle itself.

Detailed Description

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Participants will be given informed consent and will be asked to have two blood draws at specific times of the menstrual cycle or if on a birth control pill, during the active and inactive pill phases.

Conditions

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Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Valproate monotherapy

No interventions assigned to this group

2

Valproate monotherapy with combined oral contraceptive

No interventions assigned to this group

3

Lamotrigine monotherapy

No interventions assigned to this group

4

Lamotrigine monotherapy with combined oral contraceptive

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Must be a female between 13-45 years of age
* Must have a history of seizures
* Must be taking either lamotrigine (Lamictal) or valproate (Depakote) with or without a birth control pill

Exclusion Criteria

* Must not be on antidepressant medication, tranquilizers, or other forms of hormonal therapy other than the birth control pill
Minimum Eligible Age

13 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rhode Island Hospital

OTHER

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Andrew Herzog

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew G. Herzog, M.D., M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2005P000379

Identifier Type: -

Identifier Source: org_study_id

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