NCT00144872

LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures

Completed Phase 1 Last updated 29 September 2017

What this trial tests

Phase 1 trial testing Lamotrigine in Seizure, Absence in 54 participants. Completed in 22 April 2006.

Timeline

1 November 2004

Primary endpoint
22 April 2006

22 April 2006

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	1 November 2004
Primary completion	22 April 2006
Estimated completion	22 April 2006
Sites	23 locations across United States

Drugs / interventions tested

• Lamotrigine (lamotrigine) — full drug profile →

Conditions studied

• Seizure, Absence — all drugs for Seizure, Absence →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Under 12, any sex, with Seizure, Absence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Lamotrigine monotherapy for newly diagnosed typical absence seizures in children.
   Holmes GL, Frank LM, Sheth RD, Philbrook B, et al · · 2008 · cited 25× · PMID 18778916 · DOI 10.1016/j.eplepsyres.2008.07.016
2. Ask a Simple Question, Design an Elegant Study and the Rest is History.
   Strozzi I, Joshi C. · · 2026 · PMID 41658949 · DOI 10.1177/15357597251400721