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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy, Tonic-Clonic

Intervention: lamotrigine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: % change from Baseline in average monthly PGTC seizure frequency

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

Eligibility

Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

GSK Investigational Site, Buenos Aires C1428AQK, Argentina

GSK Investigational Site, Buenos Aires 1221, Argentina

GSK Investigational Site, Buenos Aires 1181, Argentina

GSK Investigational Site, Capital Federal, Argentina

GSK Investigational Site, Alabaster, Alabama 35007, United States

GSK Investigational Site, Northport, Alabama 35476, United States

GSK Investigational Site, Little Rock, Arkansas 72205, United States

GSK Investigational Site, Bakersfield, California 93309, United States

GSK Investigational Site, Denver, Colorado 80218, United States

GSK Investigational Site, Gainsville, Florida 32611, United States

GSK Investigational Site, Orlando, Florida 32835, United States

GSK Investigational Site, Panama City, Florida 32405, United States

GSK Investigational Site, West Palm Beach, Florida 33407, United States

GSK Investigational Site, Atlanta, Georgia 30309, United States

GSK Investigational Site, Atlanta, Georgia 30338, United States

GSK Investigational Site, Atlanta, Georgia 30342, United States

GSK Investigational Site, Augusta, Georgia 30912, United States

GSK Investigational Site, Boise, Idaho 83712, United States

GSK Investigational Site, Idaho Falls, Idaho 83404, United States

GSK Investigational Site, Springfield, Illinois 62702, United States

GSK Investigational Site, Wichita, Kansas 67214, United States

GSK Investigational Site, Crestview Hills, Kentucky 41017, United States

GSK Investigational Site, Lexington, Kentucky 40503, United States

GSK Investigational Site, San Isidro, Lima Lima 27, Peru

GSK Investigational Site, Baltimore, Maryland 21201, United States

GSK Investigational Site, Sharon, Massachusetts 02067, United States

GSK Investigational Site, Farmington Hills, Michigan 48334, United States

GSK Investigational Site, St. Cloud, Minnesota 56303, United States

GSK Investigational Site, Kansas City, Missouri 64108, United States

GSK Investigational Site, Cherry Hill, New Jersey 8034, United States

GSK Investigational Site, Medford, New Jersey 08055, United States

GSK Investigational Site, Asheville, North Carolina 28801, United States

GSK Investigational Site, Greenville, North Carolina 27834, United States

GSK Investigational Site, Raleigh, North Carolina 27607, United States

GSK Investigational Site, Winston-Salem, North Carolina 27157, United States

GSK Investigational Site, Canton, Ohio 44718, United States

GSK Investigational Site, Cleveland, Ohio 44195, United States

GSK Investigational Site, Toledo, Ohio 43614-5809, United States

GSK Investigational Site, Oklahoma City, Oklahoma 73104, United States

GSK Investigational Site, Medford, Oregon 97504-8456, United States

GSK Investigational Site, Portland, Oregon 97201-2984, United States

GSK Investigational Site, Natrona Heights, Pennsylvania 15065, United States

GSK Investigational Site, Santiago, Región Metro De Santiago, Chile

GSK Investigational Site, Spartanburg, South Carolina 29303, United States

GSK Investigational Site, Germantown, Tennessee 38138, United States

GSK Investigational Site, Nashville, Tennessee 37212, United States

GSK Investigational Site, Arlington, Texas 76015, United States

GSK Investigational Site, San Antonio, Texas 78229, United States

GSK Investigational Site, Salt Lake City, Utah 84102, United States

GSK Investigational Site, Salt Lake City, Utah 84113, United States

GSK Investigational Site, Valparaiso, Valparaíso 2341131, Chile

GSK Investigational Site, Bennington, Vermont 05201, United States

GSK Investigational Site, Newport News, Virginia 23601, United States

GSK Investigational Site, Madison, Wisconsin 53715, United States

Additional Information

Starting date: December 2000
Last updated: August 20, 2013

Page last updated: August 23, 2015

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