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

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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy, Tonic-Clonic
• Intervention / Treatment: Drug: lamotrigine

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1221
    • GSK Investigational Site
  • Buenos Aires, Argentina, 1181
    • GSK Investigational Site
  • Buenos Aires, Argentina, C1428AQK
    • GSK Investigational Site
  • Capital Federal, Argentina
    • GSK Investigational Site
• Chile
  • Región Metro De Santiago
    • Santiago, Región Metro De Santiago, Chile
      • GSK Investigational Site
  • Valparaíso
    • Valparaiso, Valparaíso, Chile, 2341131
      • GSK Investigational Site
• Peru
  • Lima
    • San Isidro, Lima, Peru, Lima 27
      • GSK Investigational Site
• United States
  • Alabama
    • Alabaster, Alabama, United States, 35007
      • GSK Investigational Site
    • Mobile, Alabama, United States, 36693
      • GSK Investigational Site
    • Northport, Alabama, United States, 35476
      • GSK Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • GSK Investigational Site
  • California
    • Bakersfield, California, United States, 93309
      • GSK Investigational Site
    • Irvine, California, United States, 92618
      • GSK Investigational Site
    • Northridge, California, United States, 91325
      • GSK Investigational Site
    • Sacramento, California, United States, 95871
      • GSK Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80218
      • GSK Investigational Site
  • Delaware
    • Newark, Delaware, United States, 19713
      • GSK Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • GSK Investigational Site
  • Florida
    • Gainsville, Florida, United States, 32611
      • GSK Investigational Site
    • Miami, Florida, United States, 33136
      • GSK Investigational Site
    • Miami, Florida, United States, 33125
      • GSK Investigational Site
    • Orlando, Florida, United States, 32835
      • GSK Investigational Site
    • Panama City, Florida, United States, 32405
      • GSK Investigational Site
    • Tallahassee, Florida, United States, 32308
      • GSK Investigational Site
    • Tampa, Florida, United States, 33607-6350
      • GSK Investigational Site
    • West Palm Beach, Florida, United States, 33407
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • GSK Investigational Site
    • Atlanta, Georgia, United States, 30309
      • GSK Investigational Site
    • Atlanta, Georgia, United States, 30338
      • GSK Investigational Site
    • Augusta, Georgia, United States, 30912
      • GSK Investigational Site
  • Idaho
    • Boise, Idaho, United States, 83712
      • GSK Investigational Site
    • Idaho Falls, Idaho, United States, 83404
      • GSK Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60637-1470
      • GSK Investigational Site
    • Springfield, Illinois, United States, 62702
      • GSK Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46202 - 5111
      • GSK Investigational Site
  • Kansas
    • Wichita, Kansas, United States, 67214
      • GSK Investigational Site
  • Kentucky
    • Crestview Hills, Kentucky, United States, 41017
      • GSK Investigational Site
    • Lexington, Kentucky, United States, 40503
      • GSK Investigational Site
    • Lexington, Kentucky, United States, 40536-0284
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • GSK Investigational Site
  • Massachusetts
    • Newton, Massachusetts, United States, 02459
      • GSK Investigational Site
    • Sharon, Massachusetts, United States, 02067
      • GSK Investigational Site
  • Michigan
    • Detroit, Michigan, United States, 48202
      • GSK Investigational Site
    • Farmington Hills, Michigan, United States, 48334
      • GSK Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55422
      • GSK Investigational Site
    • St. Cloud, Minnesota, United States, 56303
      • GSK Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • GSK Investigational Site
    • Springfield, Missouri, United States, 65807
      • GSK Investigational Site
    • St. Louis, Missouri, United States, 63110-1093
      • GSK Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • GSK Investigational Site
  • New Jersey
    • Cherry Hill, New Jersey, United States, 8034
      • GSK Investigational Site
    • Medford, New Jersey, United States, 08055
      • GSK Investigational Site
    • New Brunswick, New Jersey, United States, 8903
      • GSK Investigational Site
  • New York
    • Albany, New York, United States, 12205
      • GSK Investigational Site
    • Mount Vernon, New York, United States, 10550
      • GSK Investigational Site
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • GSK Investigational Site
    • Charlotte, North Carolina, United States, 28207
      • GSK Investigational Site
    • Greenville, North Carolina, United States, 27834
      • GSK Investigational Site
    • Raleigh, North Carolina, United States, 27607
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27157
      • GSK Investigational Site
  • Ohio
    • Canton, Ohio, United States, 44718
      • GSK Investigational Site
    • Cleveland, Ohio, United States, 44106
      • GSK Investigational Site
    • Cleveland, Ohio, United States, 44195
      • GSK Investigational Site
    • Toledo, Ohio, United States, 43614-5809
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • GSK Investigational Site
  • Oregon
    • Medford, Oregon, United States, 97504-8456
      • GSK Investigational Site
    • Portland, Oregon, United States, 97201-2984
      • GSK Investigational Site
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822-4201
      • GSK Investigational Site
    • Natrona Heights, Pennsylvania, United States, 15065
      • GSK Investigational Site
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • GSK Investigational Site
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • GSK Investigational Site
    • Memphis, Tennessee, United States, 38119
      • GSK Investigational Site
    • Nashville, Tennessee, United States, 37212
      • GSK Investigational Site
  • Texas
    • Arlington, Texas, United States, 76015
      • GSK Investigational Site
    • Dallas, Texas, United States, 75235
      • GSK Investigational Site
    • Fort Worth, Texas, United States, 76104
      • GSK Investigational Site
    • Houston, Texas, United States, 77030
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • GSK Investigational Site
    • Salt Lake City, Utah, United States, 84113
      • GSK Investigational Site
  • Vermont
    • Bennington, Vermont, United States, 05201
      • GSK Investigational Site
  • Virginia
    • Danville, Virginia, United States, 24541
      • GSK Investigational Site
    • Newport News, Virginia, United States, 23601
      • GSK Investigational Site
  • Washington
    • Tacoma, Washington, United States, 98405
      • GSK Investigational Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • GSK Investigational Site
    • Marshfield, Wisconsin, United States, 54449
      • GSK Investigational Site
    • Milwaukee, Wisconsin, United States, 53226
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
% change from Baseline in average monthly PGTC seizure frequency

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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. doi: 10.1212/01.wnl.0000187118.19221.e4.

Helpful 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2000
• Primary Completion (Actual): November 1, 2003
• Study Completion (Actual): March 1, 2005

Study Registration Dates

• First Submitted: August 14, 2002
• First Submitted That Met QC Criteria: August 15, 2002
• First Posted (Estimate): August 16, 2002

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: March 31, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: epilepsy; Lamotrigine; seizures; PGTC; primary generalized tonic-clonic
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Epilepsy, Generalized; Epilepsy, Tonic-Clonic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anticonvulsants; Sodium Channel Blockers; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Lamotrigine
• Other Study ID Numbers: LAM40097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Dataset Specification
   Information identifier: LAM40097
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Clinical Study Report
   Information identifier: LAM40097
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: LAM40097
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Annotated Case Report Form
   Information identifier: LAM40097
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Statistical Analysis Plan
   Information identifier: LAM40097
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Study Protocol
   Information identifier: LAM40097
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Informed Consent Form
   Information identifier: LAM40097
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register