ARTICLE | Clinical News

Firdapse amifampridine: Completed Phase III enrollment

April 7, 2014 7:00 AM UTC

Catalyst completed enrollment in a double-blind, placebo-controlled, international Phase III trial of Firdapse. The company said the number of patients enrolled is sufficient to ensure that 36 patients will be randomized into the discontinuation portion of the trial, but declined to disclose a specific number. The trial is evaluating Firdapse given 3-4 times daily in enrolled patients, who will receive a total daily dose of 30-80 mg, except in patients with moderate renal impairment, who will receive a starting dose of 10 mg. After at least 91 days, patients will be randomized to continue on Firdapse or be discontinued to placebo over 2 weeks. Following the double-blind portion of the trial, patients will receive Firdapse in a 2-year, open-label extension. ...