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Pediatric Epilepsy Study in Subjects 1-24 Months

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 2
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 focused on measuring epilepsy, pediatric, partial seizures

Eligibility Criteria

1 Month - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria: Must have completed the Open-Label Phase of protocol LAM20006 or meet criteria for LAMICTAL naive subjects as follows: A confident diagnosis of epilepsy. 4 or more partial seizures per month. current treatment with 1 or 2 anti-epileptic drugs. Exclusion criteria: Has seizures not related to epilepsy. Has a surgically implanted and functioning vagal nerve stimulator. Has previously been treated with lamotrigine. Is currently taking felbamate, ACTH (adrenocorticotrophic hormone) or is on the ketogenic diet. Use of experimental medication within 30 days of enrollment.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
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  • GSK Investigational Site
  • GSK Investigational Site
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  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Number of participants with overall, serious, drug-related treatment emergent adverse events and adverse events leading to premature study discontinuation
Change from baseline in vital signs -heart rate (HR)
Change from baseline in vital signs - weight (WT)
Change from baseline in vital signs - height (HT)
Change from baseline in vital signs - head circumference (HC)
Change from baseline in clinical chemistry parameters including Albumin and Total protein
Change from baseline in clinical chemistry parameters including alkaline phosphatase, Alanine transaminase (ALT), and Aspartate Aminotransferase (AST)
Change from baseline in clinical chemistry parameters including total bilirubin and creatinine
Change from baseline in clinical chemistry parameters including glucose (glu), potassium (K), sodium (Na) and urea
Change from baseline in hematological parameters including bands, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and total white blood cells (WBC)
Change from baseline in Hemoglobin (Hb)
Change from baseline in Mean corpuscular hemoglobin (MCH)
Change from baseline in Mean corpuscular hemoglobin concentration (MCHC)
Change from baseline in mean corpuscular volume (MCv)
Change from baseline in red blood cells (RBC)
Number of participants with treatment emergent neurological abnormalities
Number of participants with treatment emergent clinically significant ECG abnormalities
Number of participants with potentially clinically significant change in hematology parameters
Number of participants with potentially clinically significant change in clinical chemistry parameters
Number of participants with potentially clinically significant change in vital signs

Secondary Outcome Measures

Mean percentage change in seizure frequency between the Historical Baseline Phase and over the course of the 48-week Treatment Phase
Investigator's assessment of the participant's overall clinical status
Mean Maximal plasma concentration (Cmax) in serum and saliva of Lamicital -naïve participants

Full Information

First Posted
August 23, 2002
Last Updated
January 16, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00044278
Brief Title
Pediatric Epilepsy Study in Subjects 1-24 Months
Official Title
An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and In LAMICTAL-naive Subjects (1-24 Months of Age)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
epilepsy, pediatric, partial seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
lamotrigine
Primary Outcome Measure Information:
Title
Number of participants with overall, serious, drug-related treatment emergent adverse events and adverse events leading to premature study discontinuation
Time Frame
43 Months
Title
Change from baseline in vital signs -heart rate (HR)
Time Frame
Up to 43 Months
Title
Change from baseline in vital signs - weight (WT)
Time Frame
Up to 43 months
Title
Change from baseline in vital signs - height (HT)
Time Frame
Up to 43 months
Title
Change from baseline in vital signs - head circumference (HC)
Time Frame
Up to 43 months
Title
Change from baseline in clinical chemistry parameters including Albumin and Total protein
Time Frame
Up to month 43
Title
Change from baseline in clinical chemistry parameters including alkaline phosphatase, Alanine transaminase (ALT), and Aspartate Aminotransferase (AST)
Time Frame
Up to 43 moths
Title
Change from baseline in clinical chemistry parameters including total bilirubin and creatinine
Time Frame
Up to 43 months
Title
Change from baseline in clinical chemistry parameters including glucose (glu), potassium (K), sodium (Na) and urea
Time Frame
Up to 43 months
Title
Change from baseline in hematological parameters including bands, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and total white blood cells (WBC)
Time Frame
Up to 43 moths
Title
Change from baseline in Hemoglobin (Hb)
Time Frame
Up to 43 months
Title
Change from baseline in Mean corpuscular hemoglobin (MCH)
Time Frame
Up to 43 months
Title
Change from baseline in Mean corpuscular hemoglobin concentration (MCHC)
Time Frame
Up to 43 months
Title
Change from baseline in mean corpuscular volume (MCv)
Time Frame
Up to 43 months
Title
Change from baseline in red blood cells (RBC)
Time Frame
Up to 43 months
Title
Number of participants with treatment emergent neurological abnormalities
Time Frame
Up to 43 months
Title
Number of participants with treatment emergent clinically significant ECG abnormalities
Time Frame
Up to 43 months
Title
Number of participants with potentially clinically significant change in hematology parameters
Time Frame
Up to 43 months
Title
Number of participants with potentially clinically significant change in clinical chemistry parameters
Time Frame
Up to 43 months
Title
Number of participants with potentially clinically significant change in vital signs
Time Frame
Up to 43 months
Secondary Outcome Measure Information:
Title
Mean percentage change in seizure frequency between the Historical Baseline Phase and over the course of the 48-week Treatment Phase
Time Frame
Up to 48 Weeks
Title
Investigator's assessment of the participant's overall clinical status
Time Frame
Up to 43 months
Title
Mean Maximal plasma concentration (Cmax) in serum and saliva of Lamicital -naïve participants
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Must have completed the Open-Label Phase of protocol LAM20006 or meet criteria for LAMICTAL naive subjects as follows: A confident diagnosis of epilepsy. 4 or more partial seizures per month. current treatment with 1 or 2 anti-epileptic drugs. Exclusion criteria: Has seizures not related to epilepsy. Has a surgically implanted and functioning vagal nerve stimulator. Has previously been treated with lamotrigine. Is currently taking felbamate, ACTH (adrenocorticotrophic hormone) or is on the ketogenic diet. Use of experimental medication within 30 days of enrollment.
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
Mobile
State/Province
Alabama
ZIP/Postal Code
36693
Country
United States
Facility Name
GSK Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
GSK Investigational Site
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
GSK Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
GSK Investigational Site
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5235
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
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
GSK Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155-3009
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
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
GSK Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
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
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0284
Country
United States
Facility Name
GSK Investigational Site
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102-2383
Country
United States
Facility Name
GSK Investigational Site
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
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
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
8034
Country
United States
Facility Name
GSK Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
Facility Name
GSK Investigational Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
GSK Investigational Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
GSK Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
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
Akron
State/Province
Ohio
ZIP/Postal Code
44308-1062
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
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
GSK Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-2884
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
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2583
Country
United States
Facility Name
GSK Investigational Site
City
Morristown
State/Province
Tennessee
ZIP/Postal Code
37813
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
Dallas
State/Province
Texas
ZIP/Postal Code
75230
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
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
GSK Investigational Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
GSK Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
GSK Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
GSK Investigational Site
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1181
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
GSK Investigational Site
City
Parkville, Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
GSK Investigational Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
GSK Investigational Site
City
Reims Cedex
ZIP/Postal Code
51092
Country
France
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1094
Country
Hungary
Facility Name
GSK Investigational Site
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
GSK Investigational Site
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
GSK Investigational Site
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
GSK Investigational Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
GSK Investigational Site
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
GSK Investigational Site
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
GSK Investigational Site
City
Mantova
State/Province
Lombardia
ZIP/Postal Code
46100
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
GSK Investigational Site
City
Messina
State/Province
Sicilia
ZIP/Postal Code
98125
Country
Italy
Facility Name
GSK Investigational Site
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
GSK Investigational Site
City
Riga
ZIP/Postal Code
LV 1004
Country
Latvia
Facility Name
GSK Investigational Site
City
Beirut
ZIP/Postal Code
11072020
Country
Lebanon
Facility Name
GSK Investigational Site
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
GSK Investigational Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
GSK Investigational Site
City
Utrecht
ZIP/Postal Code
3584 EA
Country
Netherlands
Facility Name
GSK Investigational Site
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
GSK Investigational Site
City
Lisboa
ZIP/Postal Code
1150
Country
Portugal
Facility Name
GSK Investigational Site
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
GSK Investigational Site
City
SanJuan
ZIP/Postal Code
00936
Country
Puerto Rico
Facility Name
GSK Investigational Site
City
Bratislava
ZIP/Postal Code
833 40
Country
Slovakia
Facility Name
GSK Investigational Site
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Ankara
Country
Turkey

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.
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
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LAM20007
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
LAM20007
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LAM20007
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
LAM20007
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
LAM20007
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
LAM20007
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
LAM20007
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

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Pediatric Epilepsy Study in Subjects 1-24 Months

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