Results from a Phase 2 clinical trial showed that treatment with Ampyra (prolonged-release fampridine) brought both physical and psychological benefits to patients with multiple sclerosis (MS).
These findings, from the MOBILE study (NCT01597297), were published under the title, “Prolonged-Release Fampridine Treatment Improved Subject-Reported Impact Of Multiple Sclerosis: Item-Level Analysis Of The MSIS-29,” in the Journal of the Neurological Sciences.
Oral Ampyra is currently the only drug approved in the U.S. to specifically treat walking impairment in MS, a common disability in patients, after two Phase 3 clinical trials showed that the treatment resulted in consistent increases in walking speed. Treatment benefits, however, may extend beyond walking.
“Recent studies have demonstrated that the benefits of [Ampyra] may extend beyond walking speed,” the researchers wrote. “Improvements in arm function, physical and cognitive fatigue, mood and quality of life were reported in [Ampyra]–treated subjects with MS, who showed improvements in walking ability … The psychological benefits of [Ampyra] were also reported in the ENABLE study.”
Researchers analyzed the results of the MOBILE study, which expanded upon the ENABLE trial (NCT01480076). MOBILE evaluated the physical (walking ability) and psychological (well-being) health outcomes of subjects with progressing or relapsing MS, using the self-reported Multiple Sclerosis Impact Scale (MSIS-29) that measures both those outcomes. People assigned to the Ampyra treatment (68 patients) group received 10 mg twice daily for up to 24 weeks, and the control group (64 patients) received a placebo.
Ampyra treatment resulted in greater improvements from baseline in the MSIS-29 physical and psychological impact subscales, with differences of 89 percent and 148 percent in mean score reduction from baseline after 24 weeks, compared to placebo, respectively (lower scores represent improvement on these scales). More Ampyra-treated patients also achieved mean improvements in 16 of 20 physical and 6 of 9 psychological measures compared to those placebo after 24 weeks.
The Ampyra group also showed improvements in the 12-item Multiple Sclerosis Walking Scale (MSWS-12) at 24 weeks. In fact, patients whose MSWS-12 walking ability improved (by at least 8 points) were also seen to strengthen physically on the MSIS-29 scale, showing an 82 percent improvement from their self-reported baseline (study start) scores at week 12, and 97 percent by the study’s end.
“The results of the MOBILE study suggest that the benefits of [Ampyra] extend beyond walking speed and also improve the subject-perceived physical and psychological impact of MS versus placebo, particularly in those who show clinically meaningful increases in walking ability,” the authors concluded.
Studies with larger groups to confirm the positive effects of Ampyra are currently ongoing.