Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
occurs as a result of an obstruction within a blood vessel supplying blood to the brain. It accounts for 87 percent of all stroke cases.
occurs when a weakened blood vessel ruptures. Two types of weakened blood vessels usually cause hemorrhagic stroke: aneurysms and arteriovenous malformations(AVMs). But the most common cause of hemorrhagic stroke is uncontrolled hypertension (high blood pressure)
(transient ischemic attack) is caused by a temporary clot. Often called a “mini stroke”, these warning strokes should be taken very seriously.
There are two types of ischemic strokes. Thrombotic strokes are caused by a blood clot. (thrombus) in an artery going to the brain. The clot blocks blood flow to part of the brain. Blood clots usually form in arteries damaged by plaque.
A Double-Blind, Placebo-Controlled, Parallel-GroupStudy 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 (MILESTONE)
Do you or a love one have..
what does it mean?
The main purpose of this study sponsored by Acorda Therapeutics, Inc is to see if taking dalfampridine-ER tablets twice daily is safe and has an effect on walking abilities in people who have had a stroke. This will be measured by tests of walking and balance, questionnaires, and routine safety tests.
How long is the study?
The study may involve 12 weeks and longer depending on if you participate on the open-lable phase, The time you will
spend in the study will depend on the number of days you are able to complete
How to participate?
Please take your time to make your decision about taking part. You may discuss your decision with your friends and family. You can also discuss it with your health care team. If you have any questions, you can ask your study doctor for more explanation.
You must be..
≥ 6 months from occurrence of most recent ischemic stroke
18 Years and older
evidence of a stable walking deficit due to an ischemic stroke, as judged by the Investigator
But cannot be..
History of seizures, except simple febrile seizures
Suicide attempt within 1 year prior to the Screening Visit, or severe suicidal ideation within 6 months prior to the Screening Visit, or subject is at significant risk of suicidal behavior in the opinion of the Investigator
Previous use of AMPYRA, dalfampridine, fampridine or 4-aminopyridine (4-AP)
Initiation of a serotonin reuptake inhibitor (SSRI) within 3 months prior to the Screening Visit, or any change in dosing regimen within 3 months prior to the Screening Visit
Botulinum toxin use within 2 months prior to the Screening Visit