What is the Orchestra Study?

The Orchestra Study will examine an investigational medication called UCB0599 in patients with early-stage Parkinson’s disease. It will include patients with Parkinson’s disease (newly diagnosed or early-stage disease) from several countries across North America and Europe.

Who will take part in the Orchestra Study?

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

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.

How long will it last?

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

Visits at the study site

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.

How can I join the Parkinsons Orchestra Study?

There are several criteria to meet if you want to join the Orchestra Study. The most important ones are*:

  • Aged 40–75 years
  • Have been diagnosed with Parkinson’s disease in the past 2 years
  • Experience slowness of movement and at least one of the following:
    • Muscle stiffness/rigidity
    • Tremor/shaking
  • Have not taken any medications to treat Parkinson’s disease motor symptoms (symptoms related to movement) and are not expected to need any such medications in the next 6 months.

*There are additional criteria to enroll in the study—the study team will assess these and discuss them with you.

The study is investigating the effect of the study drug on the progression of Parkinson’s disease and associated symptoms over a longer period of time. Therefore, the Orchestra Study can only recruit individuals with mild Parkinson’s disease symptoms.

If you meet these criteria, take the pre-screener. If you pre-qualify, you will be referred to your nearest study site. At the study center, you will discuss the study in detail and find out whether you can take part.

Visit https://orchestra-study.com/ for more details

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