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

Epilepsy, Tonic-Clonic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00043901
• Other study ID #: LAM40097
• Status: Completed
• Phase: Phase 4
• First received: August 14, 2002
• Last updated: March 31, 2017
• Start date: December 1, 2000
• Est. completion date: March 1, 2005

Study information

• Verified date: March 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: March 1, 2005
• Est. primary completion date: November 1, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Generalized
• Epilepsy, Tonic-Clonic
• Seizures

Intervention

Drug:
• lamotrigine

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Capital Federal
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Valparaiso	Valparaíso
Peru	GSK Investigational Site	San Isidro	Lima
United States	GSK Investigational Site	Alabaster	Alabama
United States	GSK Investigational Site	Albany	New York
United States	GSK Investigational Site	Arlington	Texas
United States	GSK Investigational Site	Asheville	North Carolina
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Augusta	Georgia
United States	GSK Investigational Site	Bakersfield	California
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bennington	Vermont
United States	GSK Investigational Site	Boise	Idaho
United States	GSK Investigational Site	Canton	Ohio
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Cherry Hill	New Jersey
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Crestview Hills	Kentucky
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Danville	Pennsylvania
United States	GSK Investigational Site	Danville	Virginia
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Farmington Hills	Michigan
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Gainsville	Florida
United States	GSK Investigational Site	Germantown	Tennessee
United States	GSK Investigational Site	Greenville	North Carolina
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Idaho Falls	Idaho
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Irvine	California
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Marshfield	Wisconsin
United States	GSK Investigational Site	Medford	New Jersey
United States	GSK Investigational Site	Medford	Oregon
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	Mount Vernon	New York
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	Natrona Heights	Pennsylvania
United States	GSK Investigational Site	New Brunswick	New Jersey
United States	GSK Investigational Site	Newark	Delaware
United States	GSK Investigational Site	Newport News	Virginia
United States	GSK Investigational Site	Newton	Massachusetts
United States	GSK Investigational Site	Northport	Alabama
United States	GSK Investigational Site	Northridge	California
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Panama City	Florida
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Sharon	Massachusetts
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Springfield	Missouri
United States	GSK Investigational Site	Springfield	Illinois
United States	GSK Investigational Site	St. Cloud	Minnesota
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Tallahassee	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	Wichita	Kansas
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Chile,  Peru, 

References & Publications (1)

Biton V, Sackellares JC, Vuong A, Hammer AE, Barrett PS, Messenheimer JA. Double-blind, placebo-controlled study of lamotrigine in primary generalized tonic-clonic seizures. Neurology. 2005 Dec 13;65(11):1737-43. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% change from Baseline in average monthly PGTC seizure frequency
Secondary	Proportion of subjects with >/= 25%, 50%, 75% or 100% reduction in PGTC seizures %change from Baseline in average monthly seizure frequency.

External 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.