Clinical Evaluation of BW430C in Epilepsy
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: LAMICTAL (BW430C) (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
To evaluate safety information of BW430C when administered using the lower starting doses and
slower dose escalations as recommended Global Data Sheet
Clinical Details
Official title: Clinical Evaluation of BW430C in Epilepsy
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Incidence of rash in the first 8 weeks of treatment, in Japanese patients with epilepsy when administered at the same starting doses with the same dose escalation method as recommended Global Data Sheet for patients taking Valproic acid.
Secondary outcome: Efficacy of BW430C for prevention of seizures in Japanese patients with epilepsy when administered at the same starting doses and then maintained at an optimal maintenance dose.
Eligibility
Minimum age: 2 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
GSK Clinical Trials Call Center, Tokyo 151-8566, Japan
Additional Information
Starting date: July 2006
Last updated: June 28, 2007
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