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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00043901
Collaborator
(none)
141
Enrollment
87
Locations
51
Duration (Months)
1.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
141 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2000
Actual Primary Completion Date :
Nov 1, 2003
Actual Study Completion Date :
Mar 1, 2005

Outcome Measures

Primary Outcome Measures

  1. % change from Baseline in average monthly PGTC seizure frequency []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Alabaster Alabama United States 35007
2 GSK Investigational Site Mobile Alabama United States 36693
3 GSK Investigational Site Northport Alabama United States 35476
4 GSK Investigational Site Little Rock Arkansas United States 72205
5 GSK Investigational Site Bakersfield California United States 93309
6 GSK Investigational Site Irvine California United States 92618
7 GSK Investigational Site Northridge California United States 91325
8 GSK Investigational Site Sacramento California United States 95871
9 GSK Investigational Site Denver Colorado United States 80218
10 GSK Investigational Site Newark Delaware United States 19713
11 GSK Investigational Site Washington District of Columbia United States 20037
12 GSK Investigational Site Gainsville Florida United States 32611
13 GSK Investigational Site Miami Florida United States 33125
14 GSK Investigational Site Miami Florida United States 33136
15 GSK Investigational Site Orlando Florida United States 32835
16 GSK Investigational Site Panama City Florida United States 32405
17 GSK Investigational Site Tallahassee Florida United States 32308
18 GSK Investigational Site Tampa Florida United States 33607-6350
19 GSK Investigational Site West Palm Beach Florida United States 33407
20 GSK Investigational Site Atlanta Georgia United States 30309
21 GSK Investigational Site Atlanta Georgia United States 30338
22 GSK Investigational Site Atlanta Georgia United States 30342
23 GSK Investigational Site Augusta Georgia United States 30912
24 GSK Investigational Site Boise Idaho United States 83712
25 GSK Investigational Site Idaho Falls Idaho United States 83404
26 GSK Investigational Site Chicago Illinois United States 60637-1470
27 GSK Investigational Site Springfield Illinois United States 62702
28 GSK Investigational Site Indianapolis Indiana United States 46202 - 5111
29 GSK Investigational Site Wichita Kansas United States 67214
30 GSK Investigational Site Crestview Hills Kentucky United States 41017
31 GSK Investigational Site Lexington Kentucky United States 40503
32 GSK Investigational Site Lexington Kentucky United States 40536-0284
33 GSK Investigational Site Baltimore Maryland United States 21201
34 GSK Investigational Site Newton Massachusetts United States 02459
35 GSK Investigational Site Sharon Massachusetts United States 02067
36 GSK Investigational Site Detroit Michigan United States 48202
37 GSK Investigational Site Farmington Hills Michigan United States 48334
38 GSK Investigational Site Minneapolis Minnesota United States 55422
39 GSK Investigational Site St. Cloud Minnesota United States 56303
40 GSK Investigational Site Kansas City Missouri United States 64108
41 GSK Investigational Site Springfield Missouri United States 65807
42 GSK Investigational Site St. Louis Missouri United States 63110-1093
43 GSK Investigational Site Las Vegas Nevada United States 89102
44 GSK Investigational Site Cherry Hill New Jersey United States 8034
45 GSK Investigational Site Medford New Jersey United States 08055
46 GSK Investigational Site New Brunswick New Jersey United States 8903
47 GSK Investigational Site Albany New York United States 12205
48 GSK Investigational Site Mount Vernon New York United States 10550
49 GSK Investigational Site Asheville North Carolina United States 28801
50 GSK Investigational Site Charlotte North Carolina United States 28207
51 GSK Investigational Site Greenville North Carolina United States 27834
52 GSK Investigational Site Raleigh North Carolina United States 27607
53 GSK Investigational Site Winston-Salem North Carolina United States 27157
54 GSK Investigational Site Canton Ohio United States 44718
55 GSK Investigational Site Cleveland Ohio United States 44106
56 GSK Investigational Site Cleveland Ohio United States 44195
57 GSK Investigational Site Toledo Ohio United States 43614-5809
58 GSK Investigational Site Oklahoma City Oklahoma United States 73104
59 GSK Investigational Site Medford Oregon United States 97504-8456
60 GSK Investigational Site Portland Oregon United States 97201-2984
61 GSK Investigational Site Danville Pennsylvania United States 17822-4201
62 GSK Investigational Site Natrona Heights Pennsylvania United States 15065
63 GSK Investigational Site Spartanburg South Carolina United States 29303
64 GSK Investigational Site Germantown Tennessee United States 38138
65 GSK Investigational Site Memphis Tennessee United States 38119
66 GSK Investigational Site Nashville Tennessee United States 37212
67 GSK Investigational Site Arlington Texas United States 76015
68 GSK Investigational Site Dallas Texas United States 75235
69 GSK Investigational Site Fort Worth Texas United States 76104
70 GSK Investigational Site Houston Texas United States 77030
71 GSK Investigational Site San Antonio Texas United States 78229
72 GSK Investigational Site Salt Lake City Utah United States 84102
73 GSK Investigational Site Salt Lake City Utah United States 84113
74 GSK Investigational Site Bennington Vermont United States 05201
75 GSK Investigational Site Danville Virginia United States 24541
76 GSK Investigational Site Newport News Virginia United States 23601
77 GSK Investigational Site Tacoma Washington United States 98405
78 GSK Investigational Site Madison Wisconsin United States 53715
79 GSK Investigational Site Marshfield Wisconsin United States 54449
80 GSK Investigational Site Milwaukee Wisconsin United States 53226
81 GSK Investigational Site Buenos Aires Argentina 1181
82 GSK Investigational Site Buenos Aires Argentina 1221
83 GSK Investigational Site Buenos Aires Argentina C1428AQK
84 GSK Investigational Site Capital Federal Argentina
85 GSK Investigational Site Santiago Región Metro De Santiago Chile
86 GSK Investigational Site Valparaiso Valparaíso Chile 2341131
87 GSK Investigational Site San Isidro Lima Peru Lima 27

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00043901
Other Study ID Numbers:
  • LAM40097
First Posted:
Aug 16, 2002
Last Update Posted:
Apr 4, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
PGTC
Lamotrigine
epilepsy
seizures
primary generalized tonic-clonic
Additional relevant MeSH terms:
Epilepsy
Seizures
Epilepsy, Tonic-Clonic
Epilepsy, Generalized
Lamotrigine

Study Results

No Results Posted as of Apr 4, 2017