- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Positive Phase II Results for Dalfampridine (Ampyra) in Stroke Patients
Drug currently indicated for improvement of walking in patients with MS (Apr. 15)
A phase II proof-of-concept trial has found that dalfampridine (Ampyra, Acorda Therapeutics) extended-release (ER) tablets 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.
The new study included 83 participants who had experienced an ischemic stroke at least 6 months prior to enrollment and who had chronic motor deficits. As part of the crossover design, participants received both dalfampridine ER 10 mg and placebo twice daily for 14 days, with a wash-out period in between, during which participants received placebo. The primary goals of the study were to assess the drug’s safety and tolerability, as well as to explore various efficacy measures.
The most common adverse events were dizziness (10.4% for dalfampridine ER and 2.5% for placebo), nausea (3.9% and 6.2%), fatigue (5.2% and 3.7%), insomnia (5.2% and 2.5%), and arthralgia (2.6% and 3.7%).
Three participants experienced a seizure during the study. One seizure occurred while the participant was taking placebo (without prior exposure to dalfampridine ER); one occurred while the participant was taking dalfampridine ER; and one occurred because of an intentional overdose of dalfampridine ER. The overdose was judged by the study investigator to be a suicide attempt related to a recent family tragedy. All three participants recovered fully.
Improvement in walking was measured by the Timed 25-Foot Walk (T25FW). Using the crossover design, walking speed increased significantly (P < 0.05) while participants were taking dalfampridine ER compared with placebo.
Participants also showed a positive change on the Functional Independence Measurement (FIM) scale while taking dalfampridine ER compared with placebo. The FIM scale assesses an individual’s ability to perform daily tasks, such as bathing, grooming, eating, and walking independently.
Ampyra (dalfampridine) is approved by the FDA for the improvement of walking in people with multiple sclerosis.
Source: Acorda Therapeutics; April 15, 2013.