The Luma Study

STUDY BASICS

Were you diagnosed with Parkinson’s disease within the last 2 years? You may be eligible for a research study evaluating the safety and efficacy of a study drug, as compared to a placebo, to see if it may delay the progression of Parkinson’s disease in people who are in the early stage of their condition.

STUDY PURPOSE

The main purpose of this study is to look at whether the study drug works in people with early-stage Parkinson's disease, how safe it is in terms of medical problems known as “side effects”, and how the body handles taking it (tolerability).  

The study will also look at:

• How the body absorbs, processes, and removes the drug (called “pharmacokinetics”).
• How the body responds to the study drug, by looking at biomarkers. Biomarkers are substances that occur naturally in the body. They can change as a result of a disease or treatment. Biomarkers may help us understand how and if a treatment is working.

COULD THIS STUDY BE RIGHT FOR YOU?

• Are 30 to 80 years old
• Were diagnosed with Parkinson’s disease within the last 2 years and were at least 30 years old when you were diagnosed

WHAT PARTICIPANTS CAN EXPECT

Your participation in the study will last a minimum of approximately 55 weeks (a little over 1 year) and a maximum of 152 weeks (about 3 years) in total. During your participation, you will need to attend up to 20 visits at the study site.

The study will have 3 periods:

• Screening period (up to 6 weeks)
• Study treatment period (up to 144 weeks)
• Follow-up period (2 weeks after your last dose)