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LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures

Primary Purpose

Seizure, Absence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lamotrigine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seizure, Absence focused on measuring Absence Seizures, EEG, LTG, Typical Absence Epilepsy, Epilepsy, LAMICTAL

Eligibility Criteria

undefined - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria: Newly-diagnosed with absence epilepsy and never been treated with Anti-epileptic drugs (AEDs). Diagnosis demonstrated on one of two 5-minute hyperventilation tests. Investigator must judge that the subject and parent/guardian are likely to comply with all study procedures. Parent/guardian must given written informed consent. Subjects who are intellectually able to understand the concepts and procedures of the protocol must give assent by also signing the consent or by signing a separate assent form. Results of all screen assessments are judged to be clinically acceptable to the investigator and do not indicate any reasons why entry into the study would be contraindicated. Exclusion criteria: Seizures are the result of a currently active, known, and identifiable intracerebral lesion. Has partial or generalized tonic-clonic seizures. Has a progressive neurological disorder defined as being unstable for at least 12 weeks prior to the Screen Phase. Has a psychiatric disorder requiring medication, or has had a past psychiatric condition that was both judged to be severe and required hospitalization. Has any clinically significant chronic cardiac, renal, or hepatic medical condition. Has a condition that affects the absorption, distribution, metabolism, or excretion of drugs. Is currently taking any psychoactive drugs to treat hyperactivity disorder or attention deficit disorder. Has taken any investigational drug within 12 weeks prior to the Screen Phase. Is sexually active. Is either pregnant (i.e., confirmed by pregnancy test at Screen) or breastfeeding. Has a clinically significant chronic medical disorder which the investigator and/or GSK medical monitor determine warrants exclusion.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subjects receiving lamotrigine

Arm Description

Eligible subjects will receive chewable dispersible tablets of lamotrigine with a starting dose of 0.3 milligrams per kilogram administered orally.

Outcomes

Primary Outcome Measures

The proportion of subjects with no typical absence seizures for two consecutive weeks as confirmed by hyperventilation (HV) for clinical signs and 1-hour electroencephalogram (EEG)

Secondary Outcome Measures

Freq of seizures pre/post-treatment with lamotrigine, proportion of subjects with >=25, 50 and 75% decrease in seizure frequency, proportion of subjects with >=25, 50 and 75% decrease in clinical signs.

Full Information

First Posted
September 1, 2005
Last Updated
September 27, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00144872
Brief Title
LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures
Official Title
Evaluation of Lamotrigine in Subjects With Absence Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2004 (Actual)
Primary Completion Date
April 22, 2006 (Actual)
Study Completion Date
April 22, 2006 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This is an open-label study evaluating the efficacy and safety of lamotrigine (LTG) for the treatment of newly-diagnosed typical absence seizures. Subjects will be children and adolescents < 13 years of age. It will be conducted at multiple sites in the US. The study will consist of 4 phases: Screen Phase (up to 1 week), Baseline Phase (24 hours), Escalation Phase (up to 20 weeks) and Maintenance Phase (12 weeks). Subjects will receive increasing doses of LTG according to the dosing schedule until attaining seizure freedom as confirmed by hyperventilation (HV) for clinical signs and a 1-hr EEG at 2 consecutive weekly visits. At that point, subjects will move into the 12-week Maintenance Phase. Subjects who do not achieve seizure freedom upon reaching the maximum dose (10.2mg/kg/day) with the specified dose escalation will be discontinued from the study. During the Maintenance Phase, the investigators will use their best effort to maintain the subjects at the efficacious dose reached. If the subjects have unacceptable side effects or inadequate seizure control, the doses of study drug can be increased or decreased as specified in the dosing schedule. Safety will be assessed by monitoring adverse events, laboratory assessments, and serum lamotrigine levels. Health outcomes assessments will also be conducted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizure, Absence
Keywords
Absence Seizures, EEG, LTG, Typical Absence Epilepsy, Epilepsy, LAMICTAL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects receiving lamotrigine
Arm Type
Experimental
Arm Description
Eligible subjects will receive chewable dispersible tablets of lamotrigine with a starting dose of 0.3 milligrams per kilogram administered orally.
Intervention Type
Drug
Intervention Name(s)
Lamotrigine
Intervention Description
Lamotrigine will be given as chewable dispersible tablets with dosing strengths of 2, 5, 25, and 100 milligrams.
Primary Outcome Measure Information:
Title
The proportion of subjects with no typical absence seizures for two consecutive weeks as confirmed by hyperventilation (HV) for clinical signs and 1-hour electroencephalogram (EEG)
Time Frame
Up to 8 months
Secondary Outcome Measure Information:
Title
Freq of seizures pre/post-treatment with lamotrigine, proportion of subjects with >=25, 50 and 75% decrease in seizure frequency, proportion of subjects with >=25, 50 and 75% decrease in clinical signs.
Time Frame
Up to 8 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Newly-diagnosed with absence epilepsy and never been treated with Anti-epileptic drugs (AEDs). Diagnosis demonstrated on one of two 5-minute hyperventilation tests. Investigator must judge that the subject and parent/guardian are likely to comply with all study procedures. Parent/guardian must given written informed consent. Subjects who are intellectually able to understand the concepts and procedures of the protocol must give assent by also signing the consent or by signing a separate assent form. Results of all screen assessments are judged to be clinically acceptable to the investigator and do not indicate any reasons why entry into the study would be contraindicated. Exclusion criteria: Seizures are the result of a currently active, known, and identifiable intracerebral lesion. Has partial or generalized tonic-clonic seizures. Has a progressive neurological disorder defined as being unstable for at least 12 weeks prior to the Screen Phase. Has a psychiatric disorder requiring medication, or has had a past psychiatric condition that was both judged to be severe and required hospitalization. Has any clinically significant chronic cardiac, renal, or hepatic medical condition. Has a condition that affects the absorption, distribution, metabolism, or excretion of drugs. Is currently taking any psychoactive drugs to treat hyperactivity disorder or attention deficit disorder. Has taken any investigational drug within 12 weeks prior to the Screen Phase. Is sexually active. Is either pregnant (i.e., confirmed by pregnancy test at Screen) or breastfeeding. Has a clinically significant chronic medical disorder which the investigator and/or GSK medical monitor determine warrants exclusion.
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
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
GSK Investigational Site
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
GSK Investigational Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
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
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
GSK Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
GSK Investigational Site
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
GSK Investigational Site
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
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
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
GSK Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7600
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
Portland
State/Province
Oregon
ZIP/Postal Code
97239
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
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
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
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
GSK Investigational Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
GSK Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
GSK Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

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
18778916
Citation
Holmes GL, Frank LM, Sheth RD, Philbrook B, Wooten JD, Vuong A, Kerls S, Hammer AE, Messenheimer J. Lamotrigine monotherapy for newly diagnosed typical absence seizures in children. Epilepsy Res. 2008 Dec;82(2-3):124-32. doi: 10.1016/j.eplepsyres.2008.07.016. Epub 2008 Sep 7.
Results Reference
derived
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
LAM100118
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
LAM100118
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
LAM100118
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
LAM100118
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
LAM100118
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
LAM100118
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
LAM100118
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures

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