STEADY-PD III ‘Who” and ‘What’

Who can participate in  STEADY-PD III?

In order to qualify for participation in the STEADY-PD III study, you must:

  • Have a diagnosis of PD of less than 3 years
  • Be over 30 years old at the time of diagnosis
  • Be able to provide written informed consent
  • Be able  and willing to comply with study specific procedures
  • Not be taking dopaminergic therapy at the time of study enrollment
  • Not be pregnant, lactating or intend to become pregnant

Inclusion Criteria

  • Early idiopathic PD
  • Subject equal or greater to 30 years of age with diagnosis of PD less than 3 years
  • Hoehn or Yahy stage less than or equal to 2
  • Currently NOT receiving dopaminergic therapy and not projected to require therapy for 3 months
  • Amantadine and/or anticholinergics allowed if at a stable dose 8 weeks prior to baseline visit

Exclusion Criteria

  • Subjects with a diagnosis of atypical Parkinsonism
  • Exposure to dopaminergic PD therapy within 60 days prior to baseline visit or for at least 3 months prior at any point
  • History of clinically significant orthostatic hypotension

Further restrictions on participation will be provided to you by your local study research team.

What are the study procedures?

If you are interested in participating in the STEADY-PD III study, you will first have a visit with the study doctor to determine if you are eligible to participate. If you qualify, then you will have a second visit to evaluate your general health, mood and movement. Blood samples will be taken at  specific visits.

During the study you will be assigned randomly to receive either the active study drug, or a pill that looks like the study drug but has no active ingredients. You will continue to take the study drug or placebo for a total of 36 months. Your total participation time will be 37 months. There are 12 office visits and 4 telephone visits scheduled for this study to evaluate your general health, mood, movement ability to tolerate the study drug.

What are the risks associated with participation in  STEADY-PD III?

There are mild risks associated with taking blood samples that include pain or bruising at the site where the blood is taken. Some of the side effects noted for this medication are chest pain, fast or slow heart beat, dizziness and shortness of breath. Further detail on these risks is explained in the consent form. Please ask your local study research team if you have any questions or concerns.

 

 

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