Pediatric Epilepsy Study in Subjects 1-24 Months

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Lamotrigine

Criteria

Inclusion criteria:

• Must have completed the Open-Label Phase of protocol LAM20006 or meet criteria for LAMICTAL naive subjects as follows:

• A confident diagnosis of epilepsy.

• 4 or more partial seizures per month.

• current treatment with 1 or 2 anti-epileptic drugs.

Exclusion criteria:

• Has seizures not related to epilepsy.

• Has a surgically implanted and functioning vagal nerve stimulator.

• Has previously been treated with lamotrigine.

• Is currently taking felbamate, ACTH (adrenocorticotrophic hormone) or is on the ketogenic diet.

• Use of experimental medication within 30 days of enrollment.