Status:
COMPLETED
Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures
Lead Sponsor:
GlaxoSmithKline
Conditions:
Epilepsy
Epilepsy, Partial
Eligibility:
All Genders
13+ years
Phase:
PHASE3
Brief Summary
This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of partial seizures. LAMICTAL extended-release is an investiga...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Diagnosis of epilepsy with partial seizures for more than 24 weeks.
- Must experience at least 8 partial seizures during an 8-week Baseline Phase.
- Must currently be receiving treatment with a stable regimen of one or two antiepileptic drugs for at least four weeks.
- Patient or parent/caregiver must be willing and able to maintain a written daily seizure diary.
- Exclusion criteria:
- Previous treatment with lamotrigine.
- Exhibits any primary generalized seizures.
- Receiving treatment with felbamate or currently following the ketogenic diet.
- Pregnant, breastfeeding, or planning to become pregnant.
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT00113165
Start Date
October 1 2004
End Date
July 1 2007
Last Update
December 5 2016
Active Locations (148)
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1
GSK Investigational Site
Anniston, Alabama, United States, 36207
2
GSK Investigational Site
Birmingham, Alabama, United States, 35294-0021
3
GSK Investigational Site
Northport, Alabama, United States, 35476
4
GSK Investigational Site
Tuscaloosa, Alabama, United States, 35406