Acorda Therapeutics Inc Announces Positive AMPYRA (dalfampridine) Phase 2 Data In People With Post-Stroke Deficits

Monday, 15 Apr 2013 06:00am EDT 

Acorda Therapeutics Inc announced that a proof-of-concept trial found dalfampridine extended release (ER) tablets, marketed as AMPYRA (dalfampridine) Extended Release Tablets, 10 mg, improved walking in people with post-stroke deficits. Post-stroke 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. This study included 83 participants who had experienced an ischemic stroke at least six months prior to enrollment and had chronic motor deficits. As part of the crossover design, participants received both dalfampridine-ER 10 mg and placebo for 14 days twice daily, with a wash-out period in between during which participants received placebo. The primary goals of the study were to assess safety and tolerability, as well as to explore various efficacy measures. The safety findings in this study were consistent with previous clinical trials and post-marketing experience of AMPYRA in multiple sclerosis (MS). The most common adverse events reported in the study were dizziness (10.4% dalfampridine-ER, 2.5% placebo), nausea (3.9% dalfampridine-ER, 6.2% placebo), fatigue (5.2% dalfampridine-ER, 3.7% placebo), insomnia (5.2% dalfampridine-ER, 2.5% placebo) and arthralgia (2.6% dalfampridine-ER, 3.7% placebo). 

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