Parkinson’s disease is a progressive (gets worse over time) nervous system disorder that not only affects movement, but also a wide range of other things, including mood, mental function and various bodily functions. Both the pace of progression and the range of symptoms are highly variable from person to person.
Parkinson’s disease develops due to a reduction in a chemical messenger in the brain called dopamine, which is involved in the control of movement. Brain cells containing dopamine die due to a build-up of protein clumps inside them known as Lewy bodies. These clumps form due to misfolding of a protein known as alpha-synuclein. By developing medications that prevent the clumping of Lewy bodies in the brain, it may be possible to slow down the worsening of Parkinson’s disease.
In the Orchestra Study we are trying to find out if UCB0599 might be able to slow down the progression of the disease and, as a result, its symptoms as well. The study is being conducted to see if UCB0599 could delay the worsening of Parkinson’s disease symptoms by preventing the clumping of Lewy bodies in the brain and stopping their spread from cell to cell.
The study could last up to 21 months. It is composed of 3 parts:
- Part 1: Screening – you will undergo tests to see whether you can take part; this involves 2 visits to the study site
- Part 2: Treatment – if you qualify, you will have several visits to the study site and also have some home visits
- Part 3: Follow-up – this will involve one last home visit to check on your health
Over the course of the whole study, you can expect to have 13 visits at the clinic and 3 at home (if you choose to have these); some of these will be shorter visits (half a day) and some will be longer visits (full day).
Once enrolled, you will be randomly assigned (like flipping a coin) to receive either the study drug (one of two different doses) or a placebo (a placebo looks like the study drug but has no medicinally active ingredients); you will have an equal chance of receiving either the study drug or placebo. Neither you nor the study team will know which one you are taking. This ensures that the results from the tests can be compared and analyzed in a neutral way without any prejudice.
The study drug or placebo are given as two oral (by mouth) capsules to be taken together, twice a day every day for 18 months.
The study will enroll patients with Parkinson’s disease from several countries across North America and Europe. To find out if there’s a study site near you, please go to the Study Site Finder section of this website.
All medicines can have side effects, and no one can say for certain how high the chances are that you will experience any side effects. One of the aims of the Orchestra Study is to monitor which side effects of the study drug or placebo can occur.
Before you decide to join the study, you will be given written information that includes more details about potential and known side effects of the investigational medicine (this is called an Informed Consent Form), and your study doctor will also tell you about the possible risks and benefits of the study.
Throughout the study, your health and well-being will be closely monitored. If you experience any discomfort, you can contact the study doctor at any time to discuss the best course of action.
It is completely up to you to decide if you want to take part in the Orchestra Study. Whether or not you decide to participate in this study will not affect your current or future relationships with any healthcare professionals. If you decide to participate, you are free to withdraw at any time without penalty or loss of benefits to which you are otherwise entitled.
We encourage you to inform your family doctor or general practitioner and also other healthcare professionals you are seeing that you are taking part in a clinical research study; your family doctor or general practitioner may wish to contact the study team (with your permission) to request additional information.
The Orchestra Study will provide care for as long as you are in the study. At the end of the study, your care will return, in full, to the healthcare professional you are normally seeing (if he or she is not also your study doctor).
You will not have to pay for any study drug, or any tests or medical procedures you undergo as part of this study. Reasonable travel expenses and overnight stays as appropriate can be reimbursed; your study team will tell you more about how this works.
Any data collected during the study will not identify you directly and will be handled as strictly confidential. The handling of study data will always comply with the applicable privacy legislation in the country or region. More details about study-related data privacy will be explained in the informed consent form that will be given to you if you agree to participate in the study and that you will need to sign before any study assessments can be undertaken.
This study is sponsored by UCB, a global biopharma company focusing on immunology and neurology disorders, including Parkinson’s disease. UCB is building on a strong heritage in research and development to discover new treatments that focus on the needs of patients – both today and in the future.
UCB has listened and will keep listening to the evolving needs of clinical study participants and is engaging with organizations that support people with Parkinson’s disease to better understand their needs.
Among other things, the study makes use of telemedicine and home visits to reduce your travel and exposure to other people while you participate. How this works will be explained in more detail by the study team. Additionally, the study team will work within the latest guidelines to maximise your safety in terms of COVID-19 during this study.
Your participation in the Orchestra Study doesn’t prevent you from receiving a COVID-19 vaccination. We recommend that you discuss this with your study doctor.
Clinical studies use selection criteria to make sure that the potential benefits of the study drug outweigh any risk to participants and that the group of people in the study have similar disease characteristics. If you are not currently eligible for this study, please continue to talk with your healthcare professionals about other treatment options or clinical studies that you might be able to join.
It can take some time, usually years, before a new treatment is made available after a clinical study. That’s because there are rigorous processes to ensure the study really does show a benefit, and for health authorities to check and assess the effectiveness and safety of the potential treatment. You can certainly ask your study team and healthcare professionals you are seeing about how this process is going.
In order to analyze the results of the study, UCB has to wait until all patients in all countries have finished the study. For a lot of studies, this can take up to several years, depending on the duration of the study.
UCB will make the study results available in applicable public study registry databases such as clinicaltrials.gov or the EU Clinical Trials Register. You can also ask your study doctor about the availability of the study results after you have left the study. Results for the Orchestra Study are not expected to be available until spring 2024 but could also become available later than that.