LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures
Evaluation of Lamotrigine in Subjects With Absence Seizures
1 other identifier
interventional
54
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2004
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 1, 2005
CompletedFirst Posted
Study publicly available on registry
September 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2006
CompletedSeptember 29, 2017
September 1, 2017
1.5 years
September 1, 2005
September 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Up to 8 months
Secondary Outcomes (1)
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.
Up to 8 months
Study Arms (1)
Subjects receiving lamotrigine
EXPERIMENTALEligible subjects will receive chewable dispersible tablets of lamotrigine with a starting dose of 0.3 milligrams per kilogram administered orally.
Interventions
Lamotrigine will be given as chewable dispersible tablets with dosing strengths of 2, 5, 25, and 100 milligrams.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (23)
GSK Investigational Site
San Jose, California, 95128, United States
GSK Investigational Site
Loxahatchee Groves, Florida, 33470, United States
GSK Investigational Site
Melbourne, Florida, 32901, United States
GSK Investigational Site
Panama City, Florida, 32405, United States
GSK Investigational Site
Tallahassee, Florida, 32308, United States
GSK Investigational Site
Tampa, Florida, 33607-6350, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Louisville, Kentucky, 40202, United States
GSK Investigational Site
Springfield, Missouri, 65804, United States
GSK Investigational Site
Newark, New Jersey, 07103, United States
GSK Investigational Site
Buffalo, New York, 14222, United States
GSK Investigational Site
Rochester, New York, 14642, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27599-7600, United States
GSK Investigational Site
Greenville, North Carolina, 27834, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Portland, Oregon, 97239, United States
GSK Investigational Site
Germantown, Tennessee, 38138, United States
GSK Investigational Site
Nashville, Tennessee, 37212, United States
GSK Investigational Site
Fort Worth, Texas, 76104, United States
GSK Investigational Site
Seattle, Washington, 98105, United States
GSK Investigational Site
Madison, Wisconsin, 53792, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53215, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 18778916DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2005
First Posted
September 5, 2005
Study Start
November 1, 2004
Primary Completion
April 22, 2006
Study Completion
April 22, 2006
Last Updated
September 29, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.