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

Primary Purpose

Epilepsy, Tonic-Clonic

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
lamotrigine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy, Tonic-Clonic focused on measuring PGTC, Lamotrigine, epilepsy, seizures, primary generalized tonic-clonic

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
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Outcomes

Primary Outcome Measures

% change from Baseline in average monthly PGTC seizure frequency

Secondary Outcome Measures

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

Full Information

First Posted
August 14, 2002
Last Updated
March 31, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00043901
Brief Title
Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 1, 2000 (undefined)
Primary Completion Date
November 1, 2003 (Actual)
Study Completion Date
March 1, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Tonic-Clonic
Keywords
PGTC, Lamotrigine, epilepsy, seizures, primary generalized tonic-clonic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
lamotrigine
Primary Outcome Measure Information:
Title
% change from Baseline in average monthly PGTC seizure frequency
Secondary Outcome Measure Information:
Title
Proportion of subjects with >/= 25%, 50%, 75% or 100% reduction in PGTC seizures %change from Baseline in average monthly seizure frequency.

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
16344515
Citation
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.
Results Reference
result
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LAM40097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LAM40097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LAM40097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LAM40097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LAM40097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LAM40097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LAM40097
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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