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The MILESTONE Stroke Study

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The MILESTONESM Stroke Study is looking at the safety and effectiveness of an investigational medication for the treatment of walking difficulties in people who have had an ischemic stroke at least 6 months ago.

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Why is this study important?

Currently, there are no FDA approved medications available for improving the walking problems in these patients. Physical therapy and rehabilitation are the current mainstays of treatment to assist with walking problems following a stroke. Pharmaceutical companies use medical research studies such as the MILESTONESM Stroke Study to learn more about unapproved medications before they are made available to the public. By taking part in this study, you will be making a contribution to stroke therapy research.

What are the challenges related to this study?

The investigational medication has been approved as a treatment to improve walking problems associated with a different disease, however not in patients recovering from a stroke. This use is still investigational. The investigational medication is being tested in people who have had an ischemic stroke, because this condition has some nervous system changes that may be similar to what is seen in the disease for which this medication is approved. In an earlier study with about 80 participants who have had a stroke, there was some initial evidence of improvement in walking while taking the investigational medication twice a day for 2 weeks, when compared with a placebo.

Who is eligible to participate in this study?


  • be 18 years of age or older
  • have had an ischemic stroke 6 months ago or longer
  • have walking problems as a result of the ischemic stroke, such as walking more slowly or needing to use a cane or walker.


  • have a history of seizures, except simple febrile seizures
  • have moderate or severe renal impairment
  • have had Botox within the past 2 months
  • be pregnant, breastfeeding, or planning to become pregnant (if you are a woman able to have children).


All study-related visits, assessments, and study medication will be provided to participants at no cost. In addition, compensation for time and travel may be provided.

Take part in the Phase 3 clinical study for people with walking problems at least 6 months after an ischemic stroke




The content of this webpage does not imply National Stroke Association's endorsement of any product, treatment, service or entity. National Stroke Association strongly recommends that you consult with a healthcare professional about diagnosis and treatment before participating in a clinical trial. National Stroke Association has no affiliation with any specific clinical trials. 

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