Clinical Evaluation of BW430C in Epilepsy

• Status: Completed
• Trial end date: 2009-03-26
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate safety information of BW430C when administered using the lower starting doses and slower dose escalations as recommended Global Data Sheet

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Lamotrigine

Criteria

Inclusion criteria:

• Epilepsy with partial seizures

• Tonic clonic seizures

• Generalized seizures of Lennox-Gastaut

• Subjects whose seizures are easily recognizable at least one seizure per month and counts for 8 consecutive weeks prior to the start of the study drug.

• Concurrent AEDs: Subjects taking concurrent VPA.

Exclusion criteria:

• Previous participation in a study of Lamictal

• Known hypersensitivity to any drugs

• Pregnant women

• nursing mothers

• women who may be pregnant

• women contemplating pregnancy during the study period