Acorda's MS Drug Ampyra Helps Stroke Patients Walk
Editor's ChoiceMain Category: Stroke
Also Included In: Neurology / Neuroscience
Article Date: 15 Apr 2013 - 11:00 PDT
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Acorda's MS Drug Ampyra Helps Stroke Patients Walk
An Acorda Therapeutics drug, Ampyra (dalfampridine), which helps people with multiple sclerosis walk, also helps stroke patients who cannot walk, the company announced.
In a proof-of- concept Phase II study, Ampyra (dalfampridine extended release 10mg tablets) significantly improved walking in patients with post-stroke deficits.
Post-stroke deficits include impaired walking, motor and sensory function, as well as manual dexterity - collectively known as chronic neurological deficits.
These deficits often persist in stroke victims.
Ron Cohen, M.D., President and Chief Executive Officer, Acorda Therapeutic Incorporated, said:
"There were clear efficacy signals in the dalfampridine-ER post-stroke deficits trial and we therefore plan to proceed with a clinical development program for this indication. A top-line analysis of the data found dalfampridine-ER improved walking for people with mobility impairment resulting from ischemic stroke. Dalfampridine-ER treatment was also associated with a positive change versus placebo on a scale of functional independence in this study.
We are analyzing the data further to better understand the entirety of the results. After we complete the analysis, we plan to discuss the development program with the FDA.
There are more than seven million stroke survivors in the United States, and approximately half of them have some lasting mobility impairment.
There are no medications currently available for these patients, so new therapies are desperately needed."
Crossover trial
A crossover trial is when the patients spend some time on the drug that is being studied, and then switch over to placebo or another medication, participants receive each treatment in a random order. This was a crossover trial.The trial involved 83 people who had had an ischemic stroke at least six months before enrollment. They all had chronic motor deficits.
The participants received dalfampridine-ER 10 mg for 14 days and then placebo for 14 days, or vice-versa.
The study's primary outcomes were to examine the medication's tolerability and safety, as well as exploring various measures of efficacy (effectiveness).
Ampyra (dalfampridine) - Key Safety Findings from Post-Stroke Deficits Trial
As far as safety is concerned, the findings in this trial were no different from previous ones used on MS (multiple sclerosis) patients, as well as post-marketing data.The following adverse events were reported in this study:
- dizziness - 10.4% dalfampridine-ER, 2.5% placebo
- fatigue - 5.2% dalfampridine-ER, 3.7% placebo
- insomnia - 5.2% dalfampridine-ER, 2.5% placebo
- nausea - 3.9% dalfampridine-ER, 6.2% placebo
- arthralgia (joint pain) - 2.6% dalfampridine-ER, 3.7% placebo
- Seizure - one participant on dalfampridine-ER had a seizure, as did one on placebo (with no prior dalfampridine-ER exposure). Another patient had a seizure after intentional overdose of dalfampridine-ER (the study investigator judged this to be a suicide attempt after a family tragedy). All three made a full recovery.
Ampyra (dalfampridine) - Key Efficacy Findings from Post-Stroke Deficits Trial
Walking - participants' walking improvements were measured by doing a T25FW (Timed 25-Foot Walk). They found that walking speed among those on dalfampridine-ER was superior when compared to the patients on placebo.Functional Independence Measurement - also known as FIM. The FIM scale rates a person's ability to carry out everyday tasks, such as eating, grooming, bathing and walking unaided. Patients on dalfampridine-ER had better FIM scores compared to those on placebo.
Acorda says the researchers are currently measuring other efficacy characteristics.
Cohen said that the results would need to be confirmed in a much larger study, something Acorda says it has to discuss with the FDA. Experts say that Ampyra's usage for stroke patients is likely to be several years away.
Ampyra (dalfampridine) Cerebral Palsy Study Update
In a separate proof-of-concept study, involving 24 patients with cerebral palsy, dalfampridine-ER 10 mg was compared with placebo.Acorda informs that safety findings were similar to those reported from previous clinical trials and post-marketing experience of Ampyra in multiple sclerosis.
Dalfampridine-ER 10 mg showed promise for improving walking and hand strength in patients with cerebral palsy. However, the company emphasized that the data are currently being analyzed to determine whether they are robust enough to warrant further trials.
Ampyra is approved by the US FDA for improvement in walking among patients with multiple sclerosis.
MS patients with walking problems were shown to walk faster when on Ampyra.
The company added that "the findings in post-stroke deficits and CP do not impact Ampyra's proven safety and efficacy profile in people with MS."
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