Status:
COMPLETED
Clinical Evaluation of BW430C in Epilepsy
Lead Sponsor:
GlaxoSmithKline
Conditions:
Epilepsy
Eligibility:
All Genders
2-65 years
Phase:
PHASE3
Brief Summary
To evaluate safety information of BW430C when administered using the lower starting doses and slower dose escalations as recommended Global Data Sheet
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 7 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2009
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00395694
Start Date
August 7 2006
End Date
March 26 2009
Last Update
September 26 2018
Active Locations (2)
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1
GSK Investigational Site
Kumamoto, Japan, 860-8556
2
GSK Investigational Site