MILESTONE (DALF 1016 and DALF 1029)
Sponsor: ACORDA Therapeutics
Investigators: Carlos Kase MD (principal), Brigid Dwyer MD
News Release 11/21/16 - ACORDA Therapeutics announced that the MILESTONE clinical study did not show sufficient efficacy to support further development of dalfampridine to improve post-stroke walking difficulties. ACORDA elected to stop enrollment and to conduct an unblinded analysis of the MILESTONE trial after reaching enrollment of 377 participants. The primary outcome measure of the study was the proportion of participants who showed at least a 20% improvement on the 2-minute walk at week 12 as compared to baseline.
Principal Investigator: Carlos Kase MD
Sub-investigators: Jose Romero MD, Thanh Nguyen MD, Viken Babikian MD, Brigid Dwyer MD
Summary: Until recently, physical therapy and rehabilitation have been the key elements of treatment for chronic motor deficits after stroke. Currently, assumptions that motor recovery plateaus within months of a stroke are being challenged by novel motor-learning-based rehabilitation therapies such as treadmill exercise based on the concept of enhancing central nervous system plasticity. The concept of augmenting neural plasticity through training has led to research on other chronic treatment alternatives, including pharmaceutical and electrophysiological approaches for potential improvement of chronic motor deficits following stroke. Ischemic stroke is known to produce long term neurologic impairment which may be mediated, at least partially, by loss of myelin function in non-necrotic CNS tissue. Restoration of action potential conduction by dalfampridine treatment in surviving central nerve fibers with compromised myelin function may improve sensorimotor function in patients with chronic deficits following focal ischemia.
Purpose: The primary objective is to determine the effect of two dose strengths of dalfampridine-ER tablets, taken twice daily for 12 weeks, on stable walking deficits in subjects with post-ischemic stroke, as measured by the Two Minute Walk Test (2MinWT).
Inclusion Criteria (highlights only):
- Men or women aged 18 or older
- Clinical evidence of a stable walking deficit due to an ischemic stroke
- obvious slowness of movement assigned primarily to the stroke
- use of an assistive walking device such as a cane or walker
- Presence of movement pattern deviations such as stiff-legged gait, foot drop, hip hiking and hip circumduction
- ≥ 6 months from occurrence of most recent stroke
Status: Actively enrolling patients