Measurement Of Serum Levels Of Two Antiepileptic Drugs Du... | NCT00043914

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

NCT00043914

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Oct 9, 2017Actual

Enrollment

Phase

Phase 4

Conditions

Epilepsy

Interventions

lamotrigine

Countries

Not provided

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

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2002Actual

Primary Completion Date

Jan 29, 2003Actual

Completion Date

Jan 29, 2003Actual

First Submitted Date

Aug 14, 2002

First Submission Date that Met QC Criteria

Aug 15, 2002

First Posted Date

Aug 16, 2002Estimated

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

Oct 6, 2017

Last Update Posted Date

Oct 9, 2017Actual

Description Module

Brief Summary

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

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
lamotrigine	Drug

Measure	Description	Time Frame
Drug levels of lamotrigine.

Measure	Description	Time Frame
This study has no secondary outcome measures.

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15652736	Result	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.

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D014227	Triazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds