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.
High blood pressure, atrial fibrillation and smoking linked to severe stroke risk