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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 1, 2005 | ||||
| Last Updated Date | May 15, 2009 | ||||
| Start Date ICMJE | November 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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) | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00144872 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. | ||||
| Original Secondary Outcome Measures ICMJE |
Freq of sz pre/post-trt w LTG, proport of subjs w >=25, 50 and 75% dec in sz freq, proportion of subjs w >=25, 50 and 75% dec in clin signs, proport of subjs sz-free, decrease in sz freq/duration, AEs, behavioral/social functioning, overall status. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures | ||||
| Official Title ICMJE | An Open-Label Evaluation of LAMICTAL (Lamotrigine) Monotherapy for the Treatment of Newly-Diagnosed Typical Absence Seizures in Children and Adolescents | ||||
| 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. |
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| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Epilepsy | ||||
| Intervention ICMJE | Drug: lamotrigine | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | 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. Epub 2008 Sep 7. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 50 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | up to 12 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00144872 | ||||
| Responsible Party | Study Director, GSK | ||||
| Study ID Numbers ICMJE | LAM100118 | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | May 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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