A special protocol assessment (SPA) is a process in which the FDA provides evaluation and guidance on clinical trial protocols for phase III studies. The primary outcome measure for the study covered by the newly agreed SPA will be an improvement in walking as measured by the timed 25-foot walk and the MS walking scale-12 (MSWS12).
The study’s objective will be to show that individuals treated with Fampridine-SR are significantly more likely to have consistent improvements in their walking than those treated with placebo.
Currently, there are no treatments available that improve walking in MS sufferers, and physicians and patients regularly rate walking as one of the areas of greatest unmet medical need for this condition.
Secondary outcome measures for the study include the lower extremity manual muscle test (LEMMT), a standardized, five-point manual assessment of leg strength, as well as the Ashworth score for spasticity and global impressions.
“We are delighted to have reached this agreement with the FDA on the design of our pivotal study of Fampridine-SR in MS. We look forward to beginning the study as soon as possible,” said Dr Ron Cohen, president and CEO of Acorda.