Parkinsons TemPo 3 Study
Coming Together for PD Research
As a study participant there is no guarantee that you will receive any benefits from being in this study. However, the information gathered through your participation may help researchers learn new things about the investigational drug, which could potentially benefit future generations of people affected by PD.
The study doctor and study team are helping to conduct the Tempo Studies as part of their commitment to advancing potential treatment options for PD. What comes first, however, is their commitment to you – and to helping you make a choice that’s right for you.
All eligible study participants will receive at no cost:
- Study-related consultation and care
- Study visits, tests, assessments, and procedures
- Study drugs (investigational drug or placebo)
In addition, reimbursement for travel-related expenses (e.g., gas, parking, tolls) may also be available. Speak to a member of the study team for more details.
Study participation will take approximately 35 weeks.
Screening Period – UP TO 4 WEEKS
The study doctor and study staff will review your medical history and conduct a number of tests and be asked questions to determine if you are fully eligible to participate. This visit will last approximately four hours.
Study Treatment Period 27 WEEKS
You will begin taking your assigned study drug (investigational drug or placebo) as directed by the study doctor. You will be asked to attend ten study visits where you will take part in study- related tests and be asked questions to monitor your health and the effects (if any) of your assigned study drug. These visits are expected to last approximately one to two hours.
Who is Eligible to Participate?
You may be eligible to participate in the Tempo Studies if you meet the following criteria:
- Have been diagnosed with PD
- Currently taking Levodopa
- 40 to 80 years of age
- Have never received deep brain stimulation treatment
Tavapadon is an investigational drug being evaluated for treatment of PD. It is a dopamine receptor agonist designed to target a specific dopamine receptor in the brain that the Sponsor believes may help reduce PD symptoms that affect your movement and daily activities. The Sponsor believes tavapadon may also have less potential to cause some of the side effects commonly associated with currently approved dopamine agonists, which target different types of dopamine receptors.
Each of the Tempo Studies will compare the investigational drug to placebo. A placebo is an inactive material, such as a sugar pill, that looks like the investigational drug, but does not contain any active drug. Placebos play an important role in clinical research studies, as they help researchers determine if an investigational drug works better or is safer than taking nothing.
Participants in the Tempo Studies will be randomly assigned (like flipping a coin) to receive the investigational drug or placebo. Your chances of receiving the investigational drug or placebo will depend on which of the three Tempo Studies you are participating in. Neither you nor the study doctor will know if you are receiving the investigational drug; however, the study doctor can find out this information if he or she feels it is necessary for your health.
For additional information about the study drug, please speak with a member of the study staff.