Helen Hayes Hospital is accepting applicants for participation in a study examining the safety and effectiveness of an investigational medication in the treatment of long-term walking difficulties following a stroke. The Principal Investigator is Jason Greenberg, M.D., Director of Stroke Rehabilitation at Helen Hayes Hospital. The MILESTONE℠ Study, or DALF-PS-1016, is a double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of two dose strengths of Dalfampridine Extended Release Tablets for treatment of stable walking deficits in post-ischemic stroke.
This research study is designed to see if a medication called Dalfampridine-ER can improve walking after a stroke. Dalfampridine-ER has been approved by the Food and Drug Administration (FDA) to improve walking in patients with multiple sclerosis (MS), and in the United States it is marketed as Ampyra. Its use in people who have survived a stroke has not been proven effective. A small, previous study in stroke survivors showed that it did increase walking speed, but this study should provide more definite results.
To be eligible for this study:
- Subjects must have had an ischemic stroke (blockage of blood flow to the brain) at least six months before enrolling – if you had an ischemic stroke less than six months ago you can choose to be contacted at the six month mark
- Subjects must have a walking deficit which is due to the ischemic stroke
- Subjects must be 18 years old or older
Individuals are not eligible for this study if they have a:
- History of hemorrhagic stroke
- History of seizure
- Diagnosis of multiple sclerosis (MS)
The inclusion / exclusion criteria above are not comprehensive. Potential subjects will be screened for additional inclusion / exclusion criteria and individuals with certain other medical problems will not be allowed to enter the study for safety reasons. Each subject will be enrolled in the study for approximately five months, and will need to take the study medication (which will be either dalfampridine-ER or an inactive look-alike) twice daily for 12 weeks. Subjects will not be paid to participate in this research study, however they will receive a stipend for each completed visit as compensation for their time and travel costs.
This study is sponsored by Acorda Therapeutics, Inc. For further information, contact John Whalen, RN at 845-786-4854 or email@example.com
Helen Hayes Hospital in West Haverstraw is a specialty physical rehabilitation hospital that provides inpatient and outpatient care to individuals who have sustained various types of strokes, including cerebral infarction, cerebral hemorrhage and subarachnoid hemorrhage. Rehabilitation is provided for resulting disabilities, including paralysis, trouble walking, balancing, communicating, eating and dressing, as well as limitations in memory, emotional control and social skills and bowel and bladder disorders.