Friday, February 09, 2007

Good News Comes In A Pill

CONGRATS TO DR VOLLMER: NEW ORAL MS DRUG Fampridine-SR IS CLOSER DUE TO DR VOLLMER & HIS TEAM

Give Dr. Vollmer congrats on the completion and publication of his study on the new oral MS drug Fampridine-SR
PLUS...WISH DR. VOLLMER GOOD LUCK ON THE OTHER NEW MS TREATMENTS THAT HE AND HIS TEAM AT BARROW NEUROLOGICAL INSTITUTE ARE CURRENTLY WORKING ON!!!
Timothy Vollmer, M.D.Chairman, Division of NeurologyBarrow Neurological InstituteThe following study on the new oral MS drug Fampridine-SR was performed by Dr. Vollmer and 4 Doctors from:Yale UniversityUniversity of RochesterMellen Center, Cleveland Clinic FoundationWashington University
Fampridine-SR in multiple sclerosis: a randomized, double-blind, placebo-controlled, dose-ranging study
ABSTRACT:
Objective: To determine the safety of sustained-release 4-aminopyridine in subjects with mutiple sclerosis (MS) and to examine dose-related efficacy up to 40 mg twice daily.
Methods:Multicenter, randomized, double-blind, placebo-controlled, study. Following a 4-week baseline peroid, subjects were randomly assigned to receive Fampridine-SR (n=25, doses from 10 to 40 mg twice daily, increasing in 5 mg increments weekly) or placebo (n=11). A battery of assessments was performed weekly, including the MS Functional Composite (MSFC), fatigue questionnaires, and lower extremity manual muscle testing.Results: Improvement were seen in lower extremity muscle strength (prospective analysis) and walking speed (post-hoc analysis) in the Fampridine-SR group compared to placebo (unadjusted p-values of 0.01 and 0.03, respectively).
There were no significant differences in other MSFC measure or fatigue scores.The most common adverse events were dizziness, insomnia, paresthesia, asthenia, nausea, headache, and tremor. Five subjects were discontinued from Fampridine-SR because of adverse events at doses greater than 25 mg, and these included convulsions in two subjects at doses of 30 and 35 mg twice daily.
Conclusions:Future studies should employ doses up to 20 mg twice daily with lower extremity strength and walking speed as potential outcome measures.

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