Keeping Time with Parkinson’s Research

If you or a loved one have been diagnosed with Parkinson’s disease (PD), you or your loved one may be interested in participating in the TemPo Studies. They are a suite of three clinical research studies evaluating an oral investigational drug (tavapadon) to see if it may help improve PD symptoms that impact your movement and daily activities.

Learn More Am I Eligible?

About the TemPo Studies

The TemPo Studies are evaluating the efficacy and safety of the investigational drug in two different groups of patients:

People with early stage PD

(diagnosis within the past 3 years) who are not currently taking levodopa or dopamine agonists to manage symptoms

People who are currently taking levodopa to manage PD symptoms

You may be eligible to participate in the TemPo Studies if you meet the following eligibility criteria:

Have been diagnosed with PD

40 to 80 years of age

Have never received deep
brain stimulation treatment

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.

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).

Study Participation Overview

Study participation will take approximately 35 weeks

Screening Period

Up to 31 days

The study doctor and study staff will review your medical history and conduct a number of tests and assessments 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 assessments 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.

Safety Follow-Up Period

Up to 30 days after your final study visit

A member of the study team will contact you by phone for a final check-in.

Open-Label Extension (Optional)

Following the Study Treatment Period, you may have the option to participate in an Open-Label Extension study.

During the Open-Label Extension, all study participants will receive the investigational drug for an additional 58 weeks. There is no placebo in the extension. You will also be asked to attend regularly scheduled study visits to monitor your health.