Pediatric Epilepsy Study in Subjects 1-24 Months

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Epilepsy

Treatments: Drug: lamotrigine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00044278

LAM20007

Details and patient eligibility

About

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.

Enrollment: 197 patients

Sex: All

Ages: 1 to 24 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)