When was topiramate approved

The capsule also can be swallowed whole, offering patients greater flexibility. Topamax has been studied in more than 2, epilepsy subjects worldwide.

Five placebo-controlled, double blind clinical trials with Topamax demonstrated consistent results in reducing the frequency of seizures. In one trial with subjects, seizure frequency was reduced by at least half in 44 percent vs. Once stabilized on Topamax, four percent of subjects were seizure free throughout the trial period; no subjects on placebo were free of seizures during the same trial period. Patients selected for the trial were being treated with traditional AEDs; their average seizure frequency was approximately 11 per month at the time they entered the trial.

Partial onset seizures: 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. Clinical trials indicate that Topamax is generally well tolerated by subjects and has few clinically significant interactions with traditional AEDs.

The most frequently reported side effects were related to the central nervous system, which is common for this class of drugs, such as difficulty concentrating, drowsiness, dizziness and coordination problems. If the decision is made to use the medication by a woman of childbearing age, effective birth control should be used, the agency said in a release.

Skip to main content. Topiramate approved for migraine prevention in adolescents. By Mary Jo M. Skip to content. Topiramate for Migraine Prevention: An Update. John F. Font Size. Plus, Which Ones To Try. Oral and Intranasal Triptans for Migraine. Over-the-Counter Migraine Medication.