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Measurement Of Serum Levels Of Two Antiepileptic Drugs During Conversion In Patients With Epilepsy

NCT ID: NCT00043914

Last Updated: 2017-10-09

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

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-14

Study Completion Date

2003-01-29

Brief Summary

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This study includes patients 16 years of age or older with a confident diagnosis of epilepsy who are currently treated with an antiepileptic drug (AED) monotherapy but require a change in therapy due to inadequate seizure control and/or unacceptable side effects.

Detailed Description

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Conditions

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Epilepsy

Keywords

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epilepsy monotherapy conversion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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lamotrigine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 16 years old or older.
* Have confident diagnosis of epilepsy.
* Have been on the medication valproate for at least 3 months and is currently on a stable daily dose.
* Male or female; females of child-bearing potential must have negative pregnancy test at screen and must agree to use an acceptable birth control method.

Exclusion Criteria

* A history of hypersensitivity to the drug being studied.
* Currently being treated with or has been treated in the past with the drug being studied.
* Undergoing polytherapy treatment with the medication valproate and one or more other antiepileptic drug(s).
* If undergoing treatment with vagal nerve stimulation, has had device implanted more than 30 days prior to enrollment.
* Has taken an investigational drug or the medication Felbatol within the previous 30 days.
* Is abusing alcohol and/or other substances.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Countries

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United States

References

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Sale ME, Natarajan S, Biton V, Vuong A, Hammer AE, Messenheimer JA, Blum D. A dosing algorithm for converting from valproate monotherapy to lamotrigine monotherapy in patients with epilepsy. Epilepsy Behav. 2005 Feb;6(1):63-70. doi: 10.1016/j.yebeh.2004.11.002.

Reference Type RESULT
PMID: 15652736 (View on PubMed)

Study Documents

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Document Type: Informed Consent Form

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Dataset Specification

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Study Protocol

View Document

Document Type: Clinical Study Report

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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LAM40013

Identifier Type: -

Identifier Source: org_study_id