A recent study showed that the clinical benefits offered by Ampyra (fampridine) in improving mobility among multiple sclerosis (MS) patients has clinical significance.
The results were shown in an oral presentation, “Sustained clinically meaningful improvements in walking ability with prolonged-release fampridine: results from the placebo-controlled ENHANCE study,” at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Sept. 14-17 in London.
A walking disability is a hallmark of MS, and is estimated to affect 80 percent of patients with early phases of the disease. A priority goal of MS therapy is to maintain and improve mobility among patients.
Previous studies have suggested that prolonged release of Ampyra benefits the mobility of MS patients. However, doubts remained as to whether these benefits are clinically meaningful.
Ampyra is a potassium channel blocker indicated for symptomatic improvement of walking in adults with MS, including relapsing-remitting, secondary progressive, progressive relapsing and primary progressive forms of MS.
Now, researchers presented the results of the Phase 3 ENHANCE trial, the largest and longest randomized trial assessing Ampyra to date. The trial’s objective was to determine the effectiveness of Ampyra (10 mg twice a day) in providing sustained clinically meaningful benefits on patient-reported walking ability and other functional outcome measures compared to a placebo.
The ENHANCE study enrolled 646 MS patients ages 18 to 70 with progressive or relapsing MS and impaired walking (EDSS 4-7). The study’s primary endpoint was to determine the proportion of people with an improvement in the 12-item MS Walking Scale (MSWS-12) score from baseline over 24 weeks.
Secondary endpoints included the Timed Up and Go (TUG) speed, MS Impact Scale physical subscale (MSIS-29 PHYS), static balance (Berg Balance Scale [BBS]), and upper extremity function (ABILHAND questionnaire).
The results showed that a significantly higher proportion of patients treated with Ampyra achieved a clinically meaningful improvement in the MSWS-12 when compared to a placebo: 43.2 percent versus 33.6 percent, respectively, over 24-week treatment course.
Additionally, significantly more MS patients receiving Ampyra achieved a 15 percent or greater mean improvement from baseline over 24 weeks on TUG speed compared to a placebo (43.4 percent versus 34.7 percent, respectively); and also significant improvements in the MSIS-29 PHYS.
Results showed that MS patients treated with Ampyra achieved clinically meaningful benefits on self-reported walking ability, mobility, and balance sustained over 24 weeks when compared to placebo controls.