Fampridine-SR in Phase 3 Trial for Multiple Sclerosis Under FDA Guidance
May 4, 2005 - 9:55:38 PM
Acorda Therapeutics announced today that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment for a pivotal, Phase 3 clinical trial of Fampridine-SR in multiple sclerosis (MS). A Special Protocol Assessment (SPA) is a process in which the FDA provides evaluation and guidance on clinical trial protocols for Phase 3 studies.
"We are delighted to have reached this agreement with the FDA on the design of our pivotal study of Fampridine-SR in MS. We look forward to beginning the study as soon as possible," said Ron Cohen, M.D., President and CEO of Acorda Therapeutics.
The primary outcome measure for the study will be an improvement in walking as measured by the Timed 25-Foot Walk and the MS Walking Scale-12 (MSWS12). Currently, there are no treatments available that improve walking in MS sufferers, and physicians and patients regularly rate walking as one of the areas of greatest unmet medical need for this condition. Secondary outcome measures for the study include the Lower Extremity Manual Muscle Test (LEMMT), a standardized, 5-point manual assessment of leg strength, as well as the Ashworth score for spasticity and global impressions.
MS is characterized by frequent waxing and waning of the patient's walking ability, strength and other neurological functions. The objective of the study will be to show that individuals treated with Fampridine-SR are significantly more likely to have consistent improvements in their walking than those treated with placebo.
Fampridine-SR ("4-aminopyridine", "4-AP") is an investigational, sustained-release tablet formulation of 4-aminopyridine. It is being developed in human clinical trials for both MS and spinal cord injury (SCI). In laboratory studies fampridine has improved impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged.
Results from the most recent Phase 2 MS clinical trial showed a positive trend for improvement in average walking speed (as measured by the Timed 25 Foot Walk) and a statistically significant improvement in LEMMT. A post-hoc analysis, using the methods to be applied in the Phase 3 study, showed a significant increase in the number of subjects with consistently improved walking speed in the Fampridine-SR treated group versus the placebo-treated subjects. These data are consistent with from the results of earlier Phase 2 trials.
Adverse events, including serious adverse events, seen in these studies were insomnia, paresthesias (numbness/tingling), dizziness and nausea, the majority of which were rated as mild to moderate. Seizure was reported in a small number of patients at higher doses than are currently being evaluated. As Fampridine-SR is an investigational drug, safety and efficacy have not been fully determined.
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