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Home | Clinical Trials

FDA Approved Drugs » 1999
Medical Areas: Neurology | Pediatrics/Neonatology

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Topamax (topiramate)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Ortho-McNeil Pharmaceutical
Approval Status: Approved July 1999
Treatment Area: Neurology

General Information

A new use for the anti-epileptic drug, Topamax (topiramate) has been approved by the FDA. This new use is as an add-on treatment for pediatric patients (ages 2-16) who experience partial onset seizures. This is the first anti-epileptic drug to be approved for treatment of partial onset seizures in patients as young as two. Partial onset seizures can cause sensory distortion, uncontrolled movements and, in some cases, an altered, trance-like consciousness.

Topamax is available as a tablet and in a capsule formulation that can be opened and sprinkled onto food for easy swallowing. The capsule also can be swallowed whole, offering patients greater flexibility.

Clinical Results

In a double-blinded, randomized, placebo-controlled trial of 86 pediatric patients between the ages of two and 16, at 17 clinical sites, Topamax effectively reduced the frequency of partial onset seizures in this population. Pediatric patients who received Topamax as add-on therapy with baseline anti-epileptic drugs (AEDs) over the course of the 16-week trial experienced a 33% reduction in seizures, compared to 11% for placebo and baseline AEDs.

Side Effects

In the pediatric trial, the most common side effects associated with Topamax as add-on therapy included excessive drowsiness, loss of appetite, fatigue, nervousness, difficulty with concentration/attention, weight decrease, aggressive reaction, and difficulty with memory.

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