Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures - Tabular View

Tracking Information

First Received Date ^ICMJE

June 6, 2005

Last Updated Date

August 27, 2009

Start Date ^ICMJE

October 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The efficacy of LAMICTAL extended-release therapy will be measured by the percentage change from Baseline in partial seizure frequency during the double-blind treatment phase. [ Time Frame: 24 Weeks ]

Original Primary Outcome Measures ^ICMJE

The efficacy of LAMICTAL extended-release therapy will be measured by the percentage change from Baseline in partial seizure frequency during the double-blind treatment phase.

Change History

Complete list of historical versions of study NCT00113165 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Reduction in partial seizure frequency during portions of double-blind phase (=25%,=50%,=75%,100%). Time to 50% reduction in partial seizure frequency. Adverse events. Weight change. Health outcomes questionnaires. Population Pharmacokinetics [ Time Frame: 24 Weeks ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures

Official Title ^ICMJE

A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects With Partial Seizures

Brief Summary

This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of partial seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Drug: LAMICTAL extended-release

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

204

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion criteria:

Diagnosis of epilepsy with partial seizures for more than 24 weeks.
Must experience at least 8 partial seizures during an 8-week Baseline Phase.
Must currently be receiving treatment with a stable regimen of one or two antiepileptic drugs for at least four weeks.
Patient or parent/caregiver must be willing and able to maintain a written daily seizure diary.

Exclusion criteria:

Previous treatment with lamotrigine.
Exhibits any primary generalized seizures.
Receiving treatment with felbamate or currently following the ketogenic diet.
Pregnant, breastfeeding, or planning to become pregnant.

Gender

Both

Ages

13 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Brazil, Chile, Germany, India, Puerto Rico, Russian Federation, Ukraine

Administrative Information

NCT ID ^ICMJE

NCT00113165

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

LAM100034

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP