Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug - Tabular View

Tracking Information

First Received Date ^ICMJE

August 14, 2002

Last Updated Date

October 29, 2009

Start Date ^ICMJE

December 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

% change from Baseline in average monthly PGTC seizure frequency

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00043901 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportion of subjects with >/= 25%, 50%, 75% or 100% reduction in PGTC seizures %change from Baseline in average monthly seizure frequency.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug

Official Title ^ICMJE

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Evaluation of Lamotrigine Adjunctive Therapy in Subjects Wtih Primary Generalized Tonic-Clonic Seizures

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of an investigational new drug for supplemental therapy in subjects with primary generalized tonic-clonic (PGTC) seizures.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Drug: lamotrigine

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

Enrollment ^ICMJE

104

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

INCLUSION CRITERIA:

Weigh at least 13kg.
Have a confident diagnosis of epilepsy with primary generalized tonic-clonic (PGTC) seizures with or without other generalized seizure types.
Currently being treated with an antiepileptic drug(s) (AED).
Benzodiazepines are allowed with some frequency restrictions.
Vagus nerve stimulation is allowed if in place for at least 6 months prior to starting the study with no changes to the settings having occured during the month immediately prior to starting the study, and if no changes will occur during all phases of the study.
History of primary generalized tonic-clonic seizures with no focal onset.
Have at least 1 primary generalized tonic-clonic (PGTC) seizure during the 8 consecutive weeks prior to the baseline period of the study.
Have at least 3 PGTC seizures occur anytime during the 8-week baseline phase of the study.
Females must agree to acceptable form of birth control.

EXCLUSION CRITERIA:

A history of partial seizures or interictal expression of partial seizures as evidenced by electroencephalogram.
Have Lennox-Gastaut syndrome.
Currently using or has previously used the drug being studied.
Is abusing alcohol and/or other substance(s).
Has taken an investigational drug during the 30 days prior to the study or plans to take an investigational drug anytime during the study.
Is receiving chronic (long-term) treatment with any medication that could influence seizure control.
Follows the ketogenic diet.
Is planning surgery to control seizures during the study.
Is suffering from acute or progressive neurological disease, severe psychiatric disease, or severe mental abnormality.
Has any clinically significant heart, kidney, or liver condition, or a condition that affects how drugs are absorbed, distributed, metabolized, or removed from the body.

Gender

Both

Ages

2 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, Chile, Peru

Administrative Information

NCT ID ^ICMJE

NCT00043901

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

LAM40097

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2009

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