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NCT00144872 · ClinicalTrials.gov registry record · Phase 1
LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT00144872 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 54 participants.
The verdict
NCT00144872, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study 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.
Interventions
- DRUG Lamotrigine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2004-11-01 |
| Est. Completion | 2006-04-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00144872
The ClinicalTrials.gov registry entry for NCT00144872 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lamotrigine is the first listed.
NCT00144872 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00144872 about?
NCT00144872 is a clinical study titled "LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures". 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: Scree...
What is the current status of trial NCT00144872?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2004-11-01. Estimated completion is 2006-04-22.
What interventions are being tested in trial NCT00144872?
The interventions under investigation include: Lamotrigine (DRUG).
Who is sponsoring clinical trial NCT00144872?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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