Ampyra Significantly Improves Walking Ability As Reported by MS Patients, Phase 3 Trial Shows

Ampyra Significantly Improves Walking Ability As Reported by MS Patients, Phase 3 Trial Shows

Treatment with Ampyra (dalfampridine) for 24 weeks leads to sustained and clinically meaningful improvements in walking ability as reported by multiple sclerosis (MS) patients with gait difficulties, according to a study analyzing results from a Phase 3 trial.

The study, “Assessment of Clinically Meaningful Improvements in Self-Reported Walking Ability in Participants with Multiple Sclerosis: Results from the Randomized, Double-Blind, Phase III ENHANCE Trial of Prolonged-Release Fampridine” was published in the journal CNS Drugs.

More than 90 percent of MS patients have difficulty walking, which reduces their independence and negatively affects their quality of life and productivity.

Ampyra (prolonged-release dalfampridine tablets) is an approved MS medication marketed by Acorda Therapeutics in the U.S. It is the first therapy specifically approved to help improve walking in adults with MS. A generic version of Ampyra was made available this year in the U.S. by Mylan. In Europe, the medicine is approved under the brand name Fampyra, being marketed by Biogen.

An international group of researchers involved in the clinical trial ENHANCE — a large study evaluating Ampyra’s efficacy — conducted the present study to see whether the therapy could improve, in a clinically meaningful way, the walking ability of MS patients based on data from the trial.

ENHANCE was a multinational, randomized, placebo-controlled, Phase 3 study (NCT02219932) to assess whether Ampyra given over a 24-week period could reduce the walking difficulties of MS patients. The study was carried out at several centers in 10 European countries, the U.S., and Russia, and included patients with different MS subtypes.

In total, 636 MS participants, ages 18-70 and with walking difficulties, were randomized to be given either Ampyra tablets 10 mg twice a day (317 patients), or matched placebo (319 patients) for 24 weeks.

The primary endpoint of the trial was the proportion of participants exceeding an eight-point improvement (the predefined threshold for clinically meaningful improvement) on the Multiple Sclerosis Walking Scale (MSWS-12) following the 24 weeks of treatment. MSWS-12 is a patient self-assessment survey based on walking limitations because of MS.

Other outcome metrics included changes in mobility scores (Timed Up and Go speed), in the physical impact of MS (MSIS-29 physical subscale), body balance (Berg Balance Scale), and manual ability (ABILHAND).

Results showed that after the 24-week treatment, a higher proportion of Ampyra-treated patients (136 out of 315; 43.2%) had a clinically meaningful improvement in walking ability as measured by MSWS-12, compared with those given a placebo (107 out of 318; 33.6%).

This translated into an estimated 61% higher odds of patients under treatment with Ampyra getting relief from their walking difficulties.

Ampyra also led to more patients being able to move faster, as measured by TUG scores, and reporting fewer physical limitations as assessed by the MSIS-29 physical scale. Improvements in body balance and manual ability were also seen in patients receiving Ampyra, but they were not statistically significant. 

The most common adverse events associated with Ampyra were urinary infection and insomnia.

Based on the results, the researchers concluded that treatment with Ampyra “was associated with a greater likelihood of walking-impaired participants with MS experiencing clinically meaningful improvements in self-reported walking ability over 24 weeks.”

But researchers caution that while one of Ampyra’s benefits is its rapid action, those effects are lost when treatment stops . “This means that patients must be watchful” when stopping Ampyra “as their functioning can worsen soon after,” they stated.

7 comments

    • Ana Pena says:

      Dear Shannon, thank you for your comment.

      Indeed, the research team does not detail the degree of walking disability of the patients involved, however, all patients enrolled had an Expanded Disability Status Scale (EDSS) between 4 and 7 (https://www.mstrust.org.uk/a-z/expanded-disability-status-scale-edss).
      This means that all had significant disability, ranging from being “self-sufficient and up and about some 12 hours a day; able to walk without aid or rest for 500 meters” (EDSS score 4), to being “unable to walk beyond approximately 5 meters even with aid; essentially restricted to wheelchair” (EDSS score 7). I hope this information helps.

      Best regards,

      Ana

  1. Rick says:

    I take exception to this misleadingly headlined article, which implies that Ampyra improves walking ability for everyone with MS. As you state in the body of the article, only 43.2% of patients had a clinically meaningful improvement, which is only 9.6% higher than taking a placebo. Hardly worth a banner headline, especially considering the potential adverse effects oa Ampyra, such as UTIs. And what you mean by saying Ampyra produces a 61% higher chance of getting relief is anyone’s guess. Do you work for Acorda, or receive any money from them? It sure sounds like it.

    • Ana Pena says:

      Dear Rick, thank you for your comment.
      Multiple Sclerosis News Today is an independent news and information website about MS, we are not involved in the studies we report.
      We are sorry you have misunderstood the headline of the article. It is never stated that Ampyra improves the walking ability for “everyone with MS.”
      Indeed, out of the 315 patients receiving Ampyra, 43.2% had a clinically meaningful improvement in walking ability, compared to 33.6% in those taking a placebo. These results are based on assessments through the MSWS-12.
      To determine the statistic value of such findings, researchers often calculate what is called an “odds ratio” (find more about it here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2938757/)
      that is, a measure of the association between taking Ampyra (in this particular case) and not taking Ampyra.
      Of note, the odds ratio in this study was calculated based on a statistical estimation model called “adjusted logistic regression model” (more information here: https://www.pmrjournal.org/article/S1934-1482(11)00053-0/pdf) that estimates the odds taking into account several variables.

      As you can see on table 3 of the research article, the team found a mean odds ratio of 1.61 when comparing the two groups. This means that Ampyra users have 1.61 times the odds of non-users to experience improvements in walking ability. This means that patients taking Ampyra have 61% higher odds of experiencing a relief in walking difficulties, compared with those taking placebo.

      We would like to call your attention for the fact that statistically speaking “odds” is different than “risk” or “probability”, even though all are valid measures of chance. For example, if patients in the placebo group have 1 in 5 probability of feeling improvements (20% probability), then the odds are 1 to 4 (0.25), or 1 patient feeling better for every 4 that do not. Probability or risk is the ratio of occurrence over the whole, whereas odds is ratio of occurrence over the non-occurrence. This means that odds ratio is also different from risk ratio. Saying that the odds of feeling improvements are 61% higher is not the same as saying the probabilities of feeling a relief are 61% higher. Often, researchers report odds rather than risk ratios because logistic regression models yield odds ratios, not risk ratios.

      For clarity, we changed the sentence to better indicate it referred to an estimation of the magnitude of the change in odds between the Ampyra-treated group comparatively to the placebo-treated groups.

      I hope this information was helpful,

      Best regards,

      Ana Pena

  2. David Boutwell says:

    I tried in Pyro five years ago. I experienced no improvement in walking after taking the medicine daily for almost 3 weeks.
    However, I did have a negative episodic reaction with the MS. My walking worsened and the neuropathy in my feet worsened.
    I stopped taking the Ampyra within a few days and contacted my neurologist to advise him of my action.
    This was against his advice.
    My condition has been diagnosed as Secondary. Progressive MS.
    Did the study reveal anything relative to this type of side affect?

  3. cynthia says:

    I have been on Fampyra for 7 years and it has been a wonder drug for me. I was wearing a leg brace when I first started on it….but have not needed it since. My ”foot drop ” is gone except if I get extremely tired….and even then , if I rest for 10 min. or so , I seem to ”recharge” , and the foot drop disappears. I have SPMS , but have not had much progression of symptoms since I started Fampyra. I can walk further than I could 7 years ago….and stand in one spot for much longer without needing to sit down. I have not fallen in 3 years !

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