US-based biotechnology firm Acorda Therapeutics has started enrolling patients in a Phase III clinical trial of dalfampridine to treat post-stroke walking deficits (PSWD).
The multi-centre, double-blind, randomised trial is expected to enrol around 540 patients who have experienced an ischemic stroke at least six months prior to enrolment.
During the trial, patients will be given 10mg dalfampridine, 7.5mg dalfampridine, or placebo twice daily for 12 weeks.
The trial’s primary endpoint is the percentage of patients taking dalfampridine who show at least a 20% improvement in the 2 Minute Walk Test (2MinWT) compared to those receiving placebo.
The 2MinWT measures the distance a person can walk in two minutes, while other measures include the Timed Up and Go, which evaluates mobility and balance, as well as clinician and patient-reported measures.
The Phase III clinical trial of dalfampridine also includes evaluation of safety and tolerability.
Acorda Therapeutics president and CEO Ron Cohen said: "Approximately three and a half million stroke survivors in the US suffer ongoing mobility issues. This is a significant unmet medical need, as there are no approved medicines to improve walking in people with PSWD.
"Our Phase II trial of dalfampridine in PSWD produced promising data, showing significant improvements in walking speed.
"This larger Phase III trial will enrol a similar patient population, and include a number of assessments to evaluate the effect of dalfampridine in improving their walking."
In April 2013, the company reported results from a Phase II trial which showed participants had a significantly greater improvement in walking speed when receiving dalfampridine over two weeks of treatment than when receiving placebo, as measured by the Timed 25-Foot Walk test (T25FW).
Dalfampridine is the active ingredient in AMPYRA (dalfampridine) Extended Release Tablets, 10mg, approved by the FDA as a treatment to improve walking in patients with multiple sclerosis (MS).