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Study of Sustained Release Fampridine Shows Similar Effect as Placebo on QT Interval
This double-blind trial compared the electrocardiographic effects of Fampridine-SR, given at a therapeutic (10 mg twice daily) and supratherapeutic dose (30 mg twice daily), to placebo and moxifloxacin in 208 healthy subjects. Moxifloxacin is a positive control known to increase the QT interval.
The placebo-corrected QTc mean change from baseline (using the individual correction method for heart rate, or QTci) for the therapeutic and supratherapeutic doses of Fampridine-SR were 0 and 1 milliseconds, respectively. Moxifloxacin demonstrated QT prolongation consistent with previous clinical experience. In addition to no changes in the mean QTci interval, none of the subjects in the Fampridine-SR cohort showed increases in the QTci of greater than 30 milliseconds, nor did any of the Fampridine-SR subjects display a QTci interval that exceeded 480 milliseconds at any time.
Ron Cohen, Acorda's President and Chief Executive Officer, commented, "We are delighted with the results of this QT study, and are looking forward to completing our second Phase 3 trial of Fampridine-SR in multiple sclerosis patients in the second quarter of this year."
Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine
(4-aminopyridine or 4-AP). Laboratory studies have shown that fampridine can improve the communication between damaged nerves, which may result in increased neurological function. Fampridine-SR is currently being studied in a Phase 3 clinical trial to evaluate its safety and efficacy in improving walking ability in people with multiple sclerosis (MS).
Source: Acorda Therapeutics