Study participants will attend at least 12 study visits over a period of approximately ten (10) months, followed by an optional long-term extension period for an additional 40 weeks. All study-related care – including study visits, tests & assessments, and study drugs – will be provided at no cost to you.
In addition, reimbursement for study-related travel expenses (e.g., parking, tolls, and gas) is available.
During this time, the study doctor and study staff conduct a number of tests, assessments, and procedures to determine if a potential participant is fully eligible to participate.
During these visits, study participants will receive their assigned study drug (investigational drug or placebo). In addition, the study doctor will continue to conduct study-related tests, assessments and procedures to monitor the health of study participants and to gather data to help determine the effects (if any) of the investigational drug.
Study participants will return to the study location four weeks after the final Study Treatment Visit for final study-related tests, assessments and procedures.
All study participants will receive the investigational drug. There is no placebo arm in the long-term extension. As well, participants will continue to take part in study-related tests and assessments.
Study participants will be randomly assigned to one of three study treatment groups.
The placebo group plays an important role in this clinical research study, because it is the best way for researchers to measure the effects of the investigational drug on Parkinson’s disease. PROSEEK is a double-blind study, which means neither the study participant nor the study doctor will know who is receiving the investigational drug and who is receiving the placebo.
During the long-term extension, there is no placebo arm, which means that all participants will be able to receive the investigational medication.
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