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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving lamotrigine | Experimental | Eligible subjects will receive chewable dispersible tablets of lamotrigine with a starting dose of 0.3 milligrams per kilogram administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamotrigine | Drug | Lamotrigine will be given as chewable dispersible tablets with dosing strengths of 2, 5, 25, and 100 milligrams. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | San Jose | California | 95128 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18778916 | Derived | 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. |
| Label | URL |
|---|---|
| Results for study LAM100118 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| LAM100118 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| 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 |
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| LAM100118 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM100118 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM100118 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM100118 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM100118 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM100118 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D012640 | Seizures |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077213 | Lamotrigine |
| ID | Term |
|---|---|
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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