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.
- 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 10 visits at the clinic and 6 at home; 9 of these will be shorter visits (half a day) and 7 will be longer visits (full day).
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.
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.
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.
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.
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.