The Orchestra Study: An 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's Disease

  • STATUS
    Not Recruiting
  • days left to enroll
    19
  • participants needed
    450
  • sponsor
    UCB Biopharma SRL
Updated on 9 February 2023
dopamine
SPECT Scan
dopamine transporter
motor symptoms
tremor
movement disorder
bradykinesia
resting tremor
hoehn and yahr scale

Summary

The Orchestra Study (study number PD0053) is a clinical research study for people with early-stage Parkinson’s disease (<2 years). The aim of the study is to find out whether an investigational medication known as UCB0599 can slow the progression of Parkinson’s disease and whether it is efficacious and well tolerated (which means whether it works, is safe to take, and has manageable side effects).

Description

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. 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 (diagnosed within the last 2 years) who show mild symptoms.

The study can last up to 21 months for every participant. Participants will be randomly assigned (like drawing straws) to receive either the study drug (1 of 2 dose levels of either 180mg/day or 360mg/day) or placebo; they will have a 2 in 3 chance (66.6%) of receiving the study drug and a 1 in 3 chance (33.3%) of receiving placebo (a placebo looks like the study drug but contains no medicinally active ingredients). The study drug or placebo is given orally (by mouth) twice a day every day for 18 months.
 
Participation in the Orchestra Study will include visits at the study site with the study doctor and study team, as well as optional home visits. Home visits enable the study team to continue monitoring the participant's health and well-being while limiting the number of trips to the study site. A research nurse will visit the participant's home to carry out the required tests and procedures while the participant speaks to the study doctor and his or her team over video.

For more information about the study, you can visit the study website at https://orchestra-study.com.

If you want to find out if you may qualify to participate in the study, please visit the study pre-screener webpage: https://orchestra.researchstudytrial.com.
 
The study is also listed on the clinicaltrials.gov database for clinical trials: https://clinicaltrials.gov/ct2/show/NCT04658186

Details
Condition Parkinson's disease
Treatment Placebo, UCB0599
Clinical Study IdentifierNCT04658186
SponsorUCB Biopharma SRL
Last Modified on9 February 2023

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