Epilepsy
+1
Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures
Sponsored by GlaxoSmithKline
About this trial
Last updated 9 years ago
Study ID
LAM100034
Status
Completed
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
13+ Years
All Sexes
Trial Timing
Ended 19 years ago
What is this trial about?
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 investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.
What are the participation requirements?
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.