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In an article published in this issue, Goodman et al.1 conducted a randomized clinical trial to compare three doses of fampridine (10, 15, and 20 mg twice daily) to placebo for treating multiple sclerosis (MS). Although the trial results were negative, the investigators discovered an innovative method for identifying consistent responders to the drug, providing clinicians with a promising tool for treating a subset of MS patients. Is this a true positive finding or an example of data massaging?
Results of the planned portions of the trial were negative. Comparison of each dose group with placebo yielded nonsignificant results on the primary endpoint (percent change in walking speed on the timed 25-foot walk) as well as on seven of the eight secondary endpoints, despite the fact that the sample size was increased from 38 to a minimum of 50 per dose group to meet the requirements of the US Food …
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