Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures



Status:Completed
Conditions:Neurology, Neurology, Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:13 - Any
Updated:10/14/2017
Start Date:October 2004
End Date:July 2007

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A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects With Partial Seizures

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.


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.
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Salt Lake City, Utah 84132
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Anniston, Alabama 36207
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Capital Federal, Buenos Aires
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Chapel Hill, North Carolina 27599
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Chesterfield, Missouri 63017
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Cheswick, Pennsylvania 15024
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Chicago, Illinois 60611
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Columbus, Ohio 43219
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Flossmoor, Illinois 60422
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Greenville, North Carolina 27858
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