Expired Study
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Newark, New Jersey 07103


Purpose:

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.


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.


Study is Available At:


Original ID:

LAM100118


NCT ID:

NCT00144872


Secondary ID:


Study Acronym:


Brief Title:

LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures


Official Title:

Evaluation of Lamotrigine in Subjects With Absence Seizures


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

12 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

GlaxoSmithKline


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

54


Enrollment Type:

Actual


Overall Contact Information

Official Name:GSK Clinical Trials
Study Director
GlaxoSmithKline

Study Dates

Start Date:November 1, 2004
Completion Date:April 22, 2006
Completion Type:Actual
Primary Completion Date:April 22, 2006
Primary Completion Type:Actual
Verification Date:September 2017
Last Changed Date:September 27, 2017
First Received Date:September 1, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Lamotrigine
Description:Lamotrigine will be given as chewable dispersible tablets with dosing strengths of 2, 5, 25, and 100 milligrams.
Arm Name:Subjects receiving lamotrigine

Study Arms

Study Arm Type:Experimental
Arm Name:Subjects receiving lamotrigine
Description:Eligible subjects will receive chewable dispersible tablets of lamotrigine with a starting dose of 0.3 milligrams per kilogram administered orally.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:GlaxoSmithKline

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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