-- Phase II SP 667 - 200, 400, 600 mg/day* Vimpat(R) -- Phase III SP 754 - 400, 600 mg/day* Vimpat(R) -- Phase III SP 755 - 200, 400 mg/day Vimpat(R)
* The 600 mg/day dose of Vimpat(R) is not approved by the FDA. In clinical trials, the 600 mg daily dose was not more effective than the 400 mg daily dose, and was associated with a substantially higher rate of adverse reactions. Vimpat(R) dosing should start at 50 mg twice daily and maybe increased to a daily dose of 200 to 400 mg per day (recommended therapeutic dosing) administered in two divided doses.
The primary endpoints of the studies were the median percent reduction in seizure frequency per 28 days from the baseline to the maintenance period and the 50 percent responder rate, defined as the proportion of patients experiencing a 50 percent or greater reduction in partial seizure frequency per 28 days from the baseline to the maintenance period.
The studies involved a total of more than 1,300 patients, with 944 randomized to receive Vimpat(R) at one of the three doses (200 mg/day, n=270; 400 mg/day, n=471; 600 mg/day, n=203) and 364 randomized to the placebo group. Patients in the treatment groups received Vimpat(R) at 100 mg/day (50 mg twice daily) during the initial week of treatment, followed by weekly titration in 100 mg/day increments to the assigned targeted dose.
This patient group had been living with epilepsy for an average of almost
24 years. Overall, 77.4 percent of patients had tried four or more AEDs in
their lifetime and 45.2 percent had tried seven or more. Most patients (84.4
percent) were taking two or three concomitant AEDs at the time of study entry,
mainly carbamazepine (35.2 percent), lamotrigine (31.2 percent), levetiracetam
(29.0 percent), valproate (23.6 percent), and topiramate (22.3 percent). At
baseline, patients reported more than two to three times the number of
seizures per 2
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