Clinical Evaluation of BW430C in Epilepsy

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: lamictal

Study type: Interventional

Funder types: Industry

Identifiers

NCT00395694

LAM107844

Details and patient eligibility

About

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

Enrollment: 102 patients

Sex: All

Ages: 2 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

lamictal

Experimental group

Treatment:

Drug: lamictal