Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the first patient has been enrolled in a proof-of-concept study exploring the use of AMPYRA ® (dalfampridine) Extended Release Tablets, 10 mg in treating patients who have post-stroke deficits. Post-stoke deficits refer to chronic neurological deficits, such as impaired walking, motor and sensory function and manual dexterity, that persist in people who have had a stroke.
“The long-term functional deficits that result from stroke can severely impact the independence and lives of stroke survivors and their caregivers. There are no medications currently indicated to treat the chronic neurological deficits associated with stroke,” said Ron Cohen, M.D., Acorda Therapeutics’ President and CEO. “Preclinical data have shown that dalfampridine can improve functional deficits resulting from ischemic stroke, providing a strong basis for this first clinical trial in people with post-stroke deficits.”
This proof-of-concept study will assess the safety and tolerability of AMPYRA in people with stable post-stroke deficits after an ischemic stroke. Exploratory efficacy outcome measures will include: changes in walking speed, upper and lower extremity motor and sensory function, manual dexterity, assessment of functional independence in performing activities of daily living, and clinician and subject global impressions of general improvement. The study is expected to include approximately 66 people who have experienced an ischemic stroke at least six months prior to enrollment, by which time the deficits are generally stable. The Company expects to announce initial study results in early 2013.
Over seven million Americans have suffered a stroke, and about 800,000 new cases of stroke occur annually in the U.S. More than half of stroke survivors have ongoing sensorimotor and/or walking impairments, and there are no pharmaceutical treatments for such impairments.More details about the study, including sites involved in the research, can be found at: http://www.clinicaltrials.gov/ct2/show/NCT01605825?term=acorda&rank=4. AMPYRA is currently approved in the United States as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA is known as prolonged-, modified, or sustained-release fampridine (FAMPYRA ®) in some countries outside the United States. Important Safety Information AMPYRA can cause seizures; the risk of seizures increases with increasing AMPYRA doses. AMPYRA is contraindicated in patients with a prior history of seizure. Discontinue AMPYRA use if seizure occurs.