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

NCT00043914 | Completed Phase 4

• 1 other identifier: LAM40013
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epilepsy

Keywords

epilepsy; monotherapy conversion

Outcome Measures

Primary Outcomes (1)

• Drug levels of lamotrigine.

Secondary Outcomes (1)

• This study has no secondary outcome measures.

Interventions

lamotrigine DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• 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.

  PMID: 15652736 RESULT

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Epilepsy

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2002
• First Posted: August 16, 2002
• Study Start: January 14, 2002
• Primary Completion: January 29, 2003
• Study Completion: January 29, 2003
• Last Updated: October 9, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share