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CompletedNCT00043914Updated Oct 9, 2017

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

A Phase 4 interventional study of lamotrigine in Epilepsy, sponsored by GlaxoSmithKline. Completed. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2017-10-09.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jan 2002, registered Aug 2002).
Phase
Phase 4
Study type
Interventional
Enrollment
72
Allocation
Not applicable
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Epilepsy

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Keywords

  • epilepsy
  • monotherapy conversion
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 72 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
72 participants

Interventions

  • Druglamotrigine
06

What researchers measure

Primary outcomes

  1. Drug levels of lamotrigine.

Secondary outcomes

  1. This study has no secondary outcome measures.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 15652736 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00043914
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Aug 16, 2002
Start date
Jan 14, 2002
Primary completion
Jan 29, 2003
Completion
Jan 29, 2003
Last update
Oct 9, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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