Trial intelligence / Profile preview

Lamictal in Pediatric Partial Seizures (1-24 Months)

NCT00043875Phase 2

Key facts

Status: Completed
Start: May 2000
Primary completion: Nov 2003
Countries: 14
Sponsor: GSK
Modality: Small Molecules

Drugs: lamotrigine
Conditions: epilepsy

Overview

Phase 2, randomised, double-blind trial in epilepsy comparing Lamictal Continuation with Placebo Withdrawal (2 arms). Primary endpoint: Proportion of subjects who meet escape criteria. Started May 2000; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Lamictal Continuation
Continue Lamictal add-on
Placebo Withdrawal
Withdraw Lamictal to Placebo add-on

Endpoints

Primary

Proportion of subjects who meet escape criteriaDouble-Blind Phase

Secondary

Time to escape patternsDouble-Blind Phase
Reduction in partial seizure frequencyOpen-Label Phase
Investigators' global evaluation of subjects' statusDouble-Blind Phase
Standard pharmacokinetics36 Months
Adverse Events36 Months

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