A phase II study proved a drug that helps multiple sclerosis patients walk can also help stroke patients walk, Medical News Today reported.
Acorda Therapeutics, which makes Ampyra (dalfampridine), said patients with post-stroke deficits – such as impaired walking, motor and/or sensory function and manual dexterity – showed significant improvement after taking the extended release tablets.
“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,” said Dr. Ron Cohen, president and CEO of Acorda. “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.”
Cohen said after the company analyzes more data, it will be in touch with the Food and Drug Administration so a much larger study can be conducted.
Cohen said there are more than 7 million stroke survivors in the United States, and about half of them have “lasting mobility impairment,” which does not benefit from any available medications. Because of this, he said the drug is “desperately needed.”
The phase II trial involved 83 people who had an ischemic stroke at least six months prior to the study and all had chronic motor deficits. Some participants took the drug for 14 days, while others took a placebo. After the two-week period, the groups switched therapies.
Key safety findings indicated results similar to the MS study. A few adverse reactions were reported, such as dizziness, fatigue and insomnia, but overall the study’s subjects found their walking had improved and was superior to those taking the placebo.
The study also measured the subjects’ Functional Independence Measurement, or FIM, which rates a person’s ability to carry out personal grooming tasks, such as eating and bathing. Patients who were on the drug had higher FIM scores than those taking the placebos.