About the Study Drug
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.
The investigational drug is not approved by the United States (US) Food and Drug Administration (FDA).