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
    Recruiting
  • End date
    Oct 9, 2023
  • participants needed
    300
  • sponsor
    UCB Biopharma SRL
Updated on 24 September 2021
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 could last up to 21 months for every participant. Participants will be randomly assigned (like flipping a coin) to receive either the study drug or placebo; they will have an equal chance (50%) of receiving either the study drug or a 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 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 on24 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Study participant must be 40 to 75 years of age
Study participant has Parkinson's Disease (PD), with a diagnosis made by a neurologist in the last 2 years
Study participant has the following symptoms: bradykinesia plus at least one of the following: muscular rigidity, or resting tremor
A special imaging test called DaT-SPECT (Dopamine Transporter Imaging with Single Photon Emission Computed Tomography) confirms the diagnosis of PD
Study participant has no family history of certain genetically determined forms of PD (autosomal-dominant forms of PD)
Study participant meets the requirement of being in stage 2 of a special PD grading scale called “modified Hoehn and Yahr scale”
Study participant has never taken medications for the treatment of motor symptoms of PD and is not expected to require symptomatic treatment in the next 6 months
Study participant has never taken part in any research studies directed at a neurological disease with drugs that can change symptoms or progression of the disease
Study participant can comply with all aspects of the study protocol, including following the study visit schedule and collection of biologic samples (for instance but not limited to blood and urine samples)
A male participant must agree to use contraception during the Treatment Period and for at least 90 days after the last dose of study medication and refrain from donating sperm during this period
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and she either cannot bear children, or agrees to use appropriate contraception during the treatment period and at least 1 month after the last dose of study medication. The study participant must have a negative serum pregnancy test at Screening (Visit 1), which is to confirmed negative by urine testing prior to the first dose of study medication at Baseline (Visit 3). If oral contraception is used, an additional barrier method will be required during the study

Exclusion Criteria

Study participant has a known hypersensitivity to any components of the study medication or similar drugs
Study participant has a brain magnetic resonance imaging (MRI) scan performed during Screening or in the six months before that shows a relevant abnormality
Study participant cannot have a brain MRI or DaT-SPECT imaging scan performed for medical or other reasons
Study participant shows mild cognitive impairment or other significant cognitive impairment or clinical dementia at Screening according to a special scale called Montreal Cognitive Assessment (MoCA) with a score of less than 23
Study participant has abnormalities in the lumbar spine (spine in the lower back) that would interfere with a lumbar puncture (a procedure to collect fluid that surrounds the spinal cord)
Study participant has abnormalities in the electrocardiogram (ECG) results at Screening
Study participant has used medications for the treatment of motor symptoms of PD in the past (with the exception of short testing for confirmation of diagnosis) or has used drugs that can change symptoms or progression of PD
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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