Last updated: 11/04/2018 08:42:50

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

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GSK study ID
LAM40097
See study documents
Clinicaltrials.gov ID
NCT00043901
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: lamotrigine
Enrollment:
141
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Double-blind, placebo-controlled, study of lamotrigine in primary generalized tonic-clonic seizures. Biton V, Sackellares C, Vuong A, Hammer A, Barrett P, Messenheimer J. Neurology 2005;65:1737-1743.
Medical condition
Epilepsy, Tonic-Clonic
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
December 2000 to March 2005
Type
Interventional
Phase
4

Participation criteria

Sex
Female & Male
Age
2+ years
Accepts healthy volunteers
No
  • Weigh at least 13kg.
  • Have a confident diagnosis of epilepsy with primary generalized tonic-clonic (PGTC) seizures with or without other generalized seizure types.
  • A history of partial seizures or interictal expression of partial seizures as evidenced by electroencephalogram.
  • Have Lennox-Gastaut syndrome.
Inclusion and exclusion 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.

Trial location(s)

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Terminated/Withdrawn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Terminated/Withdrawn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Terminated/Withdrawn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

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-17-03

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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