The Orchestra Study is a clinical research study for people with early-stage Parkinson’s disease. The aim of the study is to see whether the investigational medication known as UCB0599 can slow the progression of Parkinson’s disease.
In order to do this, the drug UCB0599 has to be compared with a placebo – which looks like the study drug but contains no medicinally active ingredients.
The study will enroll patients with Parkinson’s disease from several countries across North America and Europe. As it is assessing disease and symptom progression over a long period of time, the Orchestra Study can only recruit patients with early-stage Parkinson’s disease who show mild symptoms.
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). 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 Orchestra Study is being conducted to see whether the investigational medication can slow the progression of Parkinson’s disease. Due to the way the study drug works in the brain, it may take some time for improvement in current symptoms or prevention of new symptoms to occur. It is also possible that your symptoms will not improve.
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. You will not have to pay for any study drug you receive as part of this study.
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
All medicines can have side effects, and one of the aims of the Orchestra Study is to monitor which side effects of the study drug or placebo can occur.
Before you enter the study, you will receive more detailed information on what side effects of the study drug are already known from previous studies; you are encouraged to talk to your study doctor about any potential side effects.
Throughout the study, your health and well-being will be closely monitored. If you have any specific concerns or think you (or the person you care for) might be experiencing a side effect, you can talk to the study team at any time.
Participation in the Orchestra Study will include visits at the study site with your doctor and study team (clinic visits), as well as home visits (if you choose to have these). These visits are to check on your well-being and to undertake the required study tests and procedures.
During a clinic visit, you will be seen in person by the study doctor and his or her team at the study site, who will perform the necessary assessments and test for that particular study visit.
Home visits enable the study team to continue monitoring your health and well-being while limiting the number of trips to the study site. A research nurse will visit your home to carry out the required tests and procedures. During the home visit, you will also speak to your study doctor and his or her team over video.
If you decide to participate in the Orchestra Study you will receive more information about the tests and procedures that are carried out during the site and home visits.
Any data collected during the study will not identify you directly and will be handled as strictly confidential. You can read more about study-related data handling and privacy 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.
Twice a day by mouth
Study site and home visits
Clinical research studies can help advance the understanding of a disease. They are the most important way for researchers to find out if potential new treatments are well tolerated and effective.
Interested?See if you qualify