LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy Seizure, Absence |
Drug: lamotrigine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label Evaluation of LAMICTAL (Lamotrigine) Monotherapy for the Treatment of Newly-diagnosed Typical Absence Seizures in Children and Adolescents |
- 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)
- 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.
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2004 |
-
Drug: lamotrigine
Eligibility| Ages Eligible for Study: | up to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, California | |
| GSK Investigational Site | |
| San Jose, California, United States, 95128 | |
| United States, Florida | |
| GSK Investigational Site | |
| Loxahatchee, Florida, United States, 33470 | |
| GSK Investigational Site | |
| Melbourne, Florida, United States, 32901 | |
| GSK Investigational Site | |
| Panama City, Florida, United States, 32405 | |
| GSK Investigational Site | |
| Tallahassee, Florida, United States, 32308 | |
| GSK Investigational Site | |
| Tampa, Florida, United States, 33607-6350 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Kentucky | |
| GSK Investigational Site | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Missouri | |
| GSK Investigational Site | |
| Springfield, Missouri, United States, 65804 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Newark, New Jersey, United States, 07103 | |
| United States, New York | |
| GSK Investigational Site | |
| Buffalo, New York, United States, 14222 | |
| GSK Investigational Site | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Chapel Hill, North Carolina, United States, 27599-7600 | |
| GSK Investigational Site | |
| Greenville, North Carolina, United States, 27834 | |
| GSK Investigational Site | |
| Raleigh, North Carolina, United States, 27607 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Germantown, Tennessee, United States, 38138 | |
| United States, Texas | |
| GSK Investigational Site | |
| Fort Worth, Texas, United States, 76104 | |
| United States, Washington | |
| GSK Investigational Site | |
| Seattle, Washington, United States, 98105 | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00144872 History of Changes |
| Other Study ID Numbers: | LAM100118 |
| Study First Received: | September 1, 2005 |
| Last Updated: | March 17, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
Absence Seizures EEG LTG |
Typical Absence Epilepsy Epilepsy LAMICTAL |
Additional relevant MeSH terms:
|
Epilepsy Epilepsy, Absence Seizures Brain Diseases Central Nervous System Diseases Nervous System Diseases Epilepsy, Generalized Neurologic Manifestations Signs and Symptoms |
Lamotrigine Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Anticonvulsants Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013