Subject Global Impression and Clinician Global Impression scales were used as secondary validators of clinical meaningfulness. Both measures also showed statistically significant improvement among Responders compared to Non-responders (p = 0.0010 and p less than 0.0001, respectively).
Statistically significant increases in leg strength, as measured by the Lower Extremity Manual Muscle Test (LEMMT), were seen in both the drug-treated Timed Walk Responders (p = 0.0002) and the drug-treated Non-responders (p = 0.046), compared to placebo-treated patients.
In an unplanned, direct comparison of Fampridine-SR vs. placebo-treated groups, the following measures were significantly improved in the Fampridine-SR-treated group: mean change in walking speed (p = 0.0004), mean change in the Lower Extremity Manual Muscle Test (p = 0.0029), and mean change in the Ashworth score for spasticity (p = 0.021).
Andrew Blight, Ph.D, Chief Scientific Officer of Acorda
Therapeutics, commented, "Walking impairment is one of the most
pervasive and serious disabilities afflicting people with MS, and
there are no currently approved therapies that are indicated to
improve walking in this population. Fampridine-SR, if approved, may
offer a novel treatment for improving walking ability in people
with MS, one that may be complementary to currently available
therapies. In this study, we also saw improvements in measures of
leg strength and spasticity compared to the placebo group. In
particular, even the Fampridine-SR group that did not show a
consistent walking improvement still showed a statistically
significant improvement in leg strength compared to the placebo
group. Further clinical studies would be required to determine
whether such additional improvements may be cli