We are working to understand if ABBV-951 is safe and effective (if it works) in treating motor fluctuations (tremors, slow movement, stiffness, and instability) in people with advanced Parkinson's
disease (individuals whose motor fluctuations are no longer, or inadequately controlled, by their conventional medications).
Participants will receive all study-related medication and care from a study doctor and study staff at no cost, as well as reimbursement for time and travel expenses.
In this study, researchers will be studying an investigational drug called ABBV-951.
The study will include 13 visits to a study clinic in your location.
The active medication in ABBV-951 is a formulation of levodopa and carbidopa, which are medications used to treat motor fluctuations in advanced Parkinson’s disease. Levodopa helps to control movement, and carbidopa helps levodopa last longer.
You may be able to take part in the study if you:
All study-related care is provided by a Study Doctor and Study Staff.
Parkinson’s disease is a medical condition which affects movement throughout the body. The body’s ‘electrical wiring’, the nervous system, contains cells that produce dopamine, a chemical which helps to carry
signals between the nerves. When the cells that produce dopamine die, the symptoms of Parkinson’s can appear.
There are a few risk factors known to be associated with Parkinson’s Disease, such as:
Parkinson’s disease symptoms may be different for everyone. Typically, people notice that the symptoms begin on one side of the body. Symptoms of Parkinson’s may include:
Although there is no specific test to diagnose Parkinson’s disease, doctors can review a patient’s medical history, the signs and symptoms a patient is experiencing, and conduct physical exams to make a clear
diagnosis. Imaging tests such as CT scans and MRIs may also be used to rule out any other diseases or disorders.1
There is no cure for Parkinson’s disease. However, people can manage their symptoms (tremor, rigidity, impaired balance, slowness of movement) by taking medication to control them. Over time, medications may not work as effectively as they used to. With disease progression, patients may experience times where the treatment is working well, and symptoms are controlled ("On" time), or not working and tremor, rigidity, slowness of movement reappear ("Off" time).
In Parkinson’s disease:
A clinical research study (also called a clinical trial) is a medical study that helps to answer important questions about an investigational drug – these may include how well the investigational drug works in treating a certain condition. All medications must be tested in clinical research studies before they can be approved and prescribed to patients. If no one took part in these studies, we would have no new medications.
A qualified participant is a person who decides to take part in the study after they have attended an in-person screening visit with a study doctor who has decided the study is right for them.
The ABBV-951-PD Study is working to understand if an investigational drug could be safe and effective in treating motor fluctuations in advanced Parkinson’s disease (individuals whose motor
fluctuations are no longer, or inadequately controlled, by their conventional medications). ABBV-951 has not been approved for use outside of this study.
The ABBV-951-PD Study will include visits to a clinic near your location.
The study will involve approximately 13 visits over 15 weeks. Some participants in the study will receive the investigational drug, and some participants will receive a drug already approved and being used to treat Parkinson’s disease. If you have any questions or concerns about this, the study team can answer those questions when they contact you. The study physician may recommend a rescue treatment to have available for any worsening of symptoms. Participants who qualify for and complete the study may be eligible to continue their treatment on an open-label extension of the study, where all participants will receive the investigational drug.
Volunteers who take part in the study may be reimbursed for travel costs and time in the study. Please discuss this with the study team when they contact you.
There is no cost to participate in the ABBV-951-PD Study. The study medication, study-related tests, assessments, and visits will be provided at no cost to you. If you decide to take part:
The research team will be able to explain more about what the ABBV-951-PD Study will involve, and it is up to you to decide if you want to take part. Participation in this study is voluntary. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.
There are risks and benefits of taking part in any clinical study. For example, your health may be more closely monitored than it would have been otherwise. You may also benefit from taking the investigational drug, though this cannot be guaranteed. Your health may get better, it may stay the same, or it may get worse. The known risks and benefits of participation are outlined in the informed consent form (ICF) that you must read and sign before you can take part.
We match you to a research center within a close travel distance from your home. If we are not running any trials in your area currently, we will keep you in our database and reach out once a study in your area becomes available.
What happens if I Sign Up? If you think you might like to learn more about the ABBV-951-PD Study, please enter your information below so we can see if you qualify and can contact you about the study.
If you qualify, we will match you to a study site/research center in your area that is seeking participants or notify you when one becomes available. The study team will contact you to explain more about the study before you make your decision about participating. You will attend an in-person visit where the study team will help determine if you qualify and if the study is right for you.