LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures

Condition(s) targeted: Epilepsy

Intervention: lamotrigine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: An Open-Label Evaluation of LAMICTAL (Lamotrigine) Monotherapy for the Treatment of Newly-Diagnosed Typical Absence Seizures in Children and Adolescents

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: 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: 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.

Minimum age: N/A. Maximum age: 12 Years. Gender(s): Both.

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.

GSK Clinical Trials Call Center, San Jose, California 95128, United States

GSK Clinical Trials Call Center, Melbourne, Florida 32901, United States

GSK Clinical Trials Call Center, Tampa, Florida 33609, United States

GSK Clinical Trials Call Center, Loxahatchee, Florida 33470, United States

GSK Clinical Trials Call Center, Tallahassee, Florida 32308, United States

GSK Clinical Trials Call Center, Panama City, Florida 32405, United States

GSK Clinical Trials Call Center, Atlanta, Georgia 30342, United States

GSK Clinical Trials Call Center, Louisville, Kentucky 40202, United States

GSK Clinical Trials Call Center, Newark, New Jersey 07103, United States

GSK Clinical Trials Call Center, Rochester, New York 14642, United States

GSK Clinical Trials Call Center, Buffalo, New York 14222, United States

GSK Clinical Trials Call Center, Greenville, North Carolina 27834, United States

GSK Clinical Trials Call Center, Raleigh, North Carolina 27607, United States

GSK Clinical Trials Call Center, Chapel Hill, North Carolina 27599, United States

GSK Clinical Trials Call Center, Portland, Oregon 97201, United States

GSK Clinical Trials Call Center, Germantown, Tennessee 38138, United States

GSK Clinical Trials Call Center, Nashville, Tennessee 37232, United States

GSK Clinical Trials Call Center, Ft. Worth, Texas 76104, United States

GSK Clinical Trials Call Center, Seattle, Washington 98105, United States

GSK Clinical Trials Call Center, Milwaukee, Wisconsin 53226, United States

GSK Clinical Trials Call Center, Milwaukee, Wisconsin 53221, United States

GSK Clinical Trials Call Center, Milwaukee, Wisconsin 53221, United States

GSK Clinical Trials Call Center, Madison, Wisconsin 53792, United States

Starting date: December 2004
Last updated: September 21, 2006