What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease, such as levodopa, cholinesterase inhibitors, and dopamine agonists, have a range of side effects. Levodopa can cause nausea, dizziness, headache, confusion, hallucinations, and motor complications like dyskinesia and motor fluctuations. Cholinesterase inhibitors, used for cognitive impairment, may lead to worsened tremor, nausea, and vomiting. Dopamine agonists can result in nonmotor side effects including edema, somnolence, constipation, dizziness, hallucinations, and nausea. These side effects highlight the need for new treatments like UCB0599 that may offer better safety and tolerability profiles.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Parkinson's Disease, primarily focusing on symptomatic relief. These include levodopa, often combined with carbidopa, which remains the most effective treatment for motor symptoms. Dopamine agonists like pramipexole and ropinirole, and MAO-B inhibitors such as selegiline and rasagiline, are also approved. While these treatments primarily address symptoms, there is ongoing research into neuroprotective or disease-modifying agents like UCB0599. Other investigational drugs include PF-06649751, a D1/D5 dopamine receptor partial agonist, which has shown promise in early trials.

What other types of research exist?

Promising, novel alternatives to UCB0599 for Parkinson's Disease patients include SK609, which improves cognitive and motor performance, and UCP0054278, which offers neuroprotective effects by preventing dopaminergic neural cell death and reducing oxidative stress.

← Back to Search

Unknown

Oral UCB0599 for Parkinson's Disease (ORCHESTRA Trial)

Phase 2

Waitlist Available

Research Sponsored by UCB Biopharma SRL

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Study participant does not take N-acetyl cysteine or other cysteine donors or glutathione precursors on a regular basis as a food supplement

Study participant must be 40 to 75 years of age inclusive, at the time of signing the informed consent

Must not have

Montreal Cognitive Assessment (MoCA) score less than 23 at Screening

Brain MRI scan performed during Screening indicative of a clinically significant abnormality or a historical MRI scan during the 6 months before Screening Visit 1 of sufficient quality to show such abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to 19 months

Summary

This trial is testing a new drug called UCB0599 to see if it can help people with early-stage Parkinson's Disease. UCB0599 is an oral medication aimed at slowing disease progression. The goal is to find out if UCB0599 can slow down the worsening of symptoms over several months. Researchers are comparing it to another treatment to check its effectiveness and safety.

Who is the study for?

This trial is for people aged 40-75 with early-stage Parkinson's Disease who haven't used disease-modifying treatments or drugs for motor symptoms. They must meet specific diagnostic criteria, have a BMI of 16 to 34kg/m², and agree to contraception use. Exclusions include hypersensitivity to the drug, significant brain MRI abnormalities, low cognitive assessment scores, ECG issues, and spine problems preventing lumbar puncture.

What is being tested?

The study tests UCB0599 against a placebo in slowing Parkinson's progression over 18 months. Participants will be randomly assigned to receive either the drug or placebo orally and monitored for changes in their clinical symptoms related to disease advancement.

What are the potential side effects?

While not specified here, potential side effects may include gastrointestinal discomforts like nausea or diarrhea; allergic reactions; fatigue; dizziness; headaches; mood changes; sleep disturbances. The exact side effects will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I do not regularly take supplements like N-acetyl cysteine.

Select...

I am between 40 and 75 years old.

Select...

My Parkinson's disease is in the early or mid-stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My memory and thinking test score is below 23.

Select...

My recent brain MRI shows significant abnormalities.

Select...

I am not allergic to any of the study or similar drugs' ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to 19 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to 19 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 19 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III sum score

Secondary study objectives

Change in Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) mean striatum specific binding ratios (SBR)

Emerging symptoms as measured by MDS-UPDRS Part II

Incidence of TEAEs leading to participant withdrawal

+10 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: UCB0599 Low Dose ArmExperimental Treatment1 Intervention

Participants will be randomized to receive a predefined low dosage of UCB0599 during the Treatment Period.

Group II: UCB0599 High Dose ArmExperimental Treatment1 Intervention

Participants will be randomized to receive a predefined high dosage of UCB0599 during the Treatment Period.

Group III: Placebo ArmPlacebo Group1 Intervention

Participants will be randomized to receive a predefined dosage of Placebo during the Treatment Period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

UCB0599

2019

Completed Phase 2

~600

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Parkinson's Disease (PD) include levodopa, dopamine agonists, MAO-B inhibitors, and amantadine. Levodopa is converted to dopamine in the brain, replenishing the diminished levels of this neurotransmitter. Dopamine agonists mimic dopamine by stimulating dopamine receptors directly. MAO-B inhibitors prevent the breakdown of brain dopamine, thereby increasing its availability. Amantadine promotes dopamine release and has anticholinergic effects. These treatments primarily address the symptomatic relief of PD. However, potential neuroprotective or disease-modifying agents like UCB0599 aim to slow disease progression by targeting underlying mechanisms such as oxidative stress and mitochondrial dysfunction. This is crucial for PD patients as it could potentially alter the course of the disease, offering more than just symptomatic relief.

Advances in drug development for Parkinson's disease: present status.Neuropharmacological approach against MPTP (1-methyl-4-phenyl-1,2,3,6- tetrahydropyridine)-induced mouse model of Parkinson's disease.