Previous research has shown that prolonged-release fampridine (PR-FAM) can help walking ability in patients with multiple sclerosis (MS), however, itâ€™s unclear whether those findings are clinically significant.
Nearly 80% of people with multiple sclerosis (MS) experience walking disability and it can begin in the early stages of the disease. Previous research has shown that prolonged-release fampridine (PR-FAM) can help these patients, however, it’s unclear whether those findings are clinically significant.
The phase 3 ENHANCE trial looked at how walking ability, mobility, and balance was impacted by PR-FAM. The results were presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2016) in London, England. This trial was led by researchers in the United Kingdom and also included some from other parts of Europe and the United States.
A total of 646 patients with MS (either progressive or relapsing) were included in the cohort. Ages ranged from 18 to 70 and all participants had impaired walking — defined as Expanded Disability Status Scale of four to seven. Half received PR-FAM 10 mg twice per day while the other half blindly took a placebo. Baseline characteristics were similar between the groups.
“The primary endpoint was proportion of people with a mean improvement in 12-item MS Walking Scale (MSWS-12) score exceeding a predetermined threshold (>8-point) from Baseline over 24 weeks,” the authors explained. Data was also reported from 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).
From the 633 participants who took more than one dose of PR-FAM or placebo (315 and 318, respectively), significantly more people in the actual treatment group achieved that >8-point MSWS-12 improvement (43.2% vs. 33.6%, respectively).
In addition, 43.4% in the PR-FAM group and 34.7% in the placebo group achieved an average of >15% improvement of TUG speed form baseline to the end of the trial. There was also a greater improvement average in the treatment group on the MSIS-PHYS measure. However, none of the other scales — BBS and ABILHAND questionnaire – showed statistically significant differences between the groups.
There were no new safety concerns found during the study.
The findings indicate that PR-FAM can help patients with MS achieve clinically significant improvements in walking ability, mobility, and balance — which is sustained over 24 weeks.
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