UCB0022 for Parkinson's Disease

(ATLANTIS Trial)

No longer recruiting at 69 trial locations
UC
Overseen ByUCB Cares
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: UCB Biopharma SRL
Must be taking: Levodopa
Stay on Your Current MedsYou can continue your current medications while participating
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication, UCB0022, to determine if it can help individuals with advanced Parkinson's Disease (PD) reduce "OFF time," when usual medications are ineffective. Participants will receive either UCB0022 at one of two doses or a placebo (a pill with no active medication) for comparison. The trial seeks individuals who have had Parkinson's for at least five years, experience significant daily motor fluctuations, and are already taking medications like levodopa. Those fitting this description and interested in trying a new treatment may consider this trial. As a Phase 2 trial, the study measures how well UCB0022 works in an initial, smaller group, contributing to important research.

Do I have to stop taking my current medications for this trial?

The trial does not specify that you need to stop taking your current medications. In fact, it requires participants to be on a stable dose of standard-of-care treatments, including levodopa therapy.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. In fact, it requires participants to continue their stable dose of standard Parkinson's treatments, including levodopa.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that UCB0022 has been tested for safety and tolerability in both healthy individuals and those with Parkinson's Disease. Past participants generally tolerated UCB0022 well. However, like any medication, it can cause side effects. Although specific side effects are not detailed, the progression to this trial phase suggests a basic level of safety. This trial represents another step in understanding how safe and effective UCB0022 is for people with Parkinson's Disease.12345

Why do researchers think this study treatment might be promising for Parkinson's Disease?

Unlike the standard treatments for Parkinson's disease, which often include medications like levodopa or dopamine agonists targeting dopamine replacement, UCB0022 offers a novel approach. Researchers are excited about UCB0022 because it employs a unique mechanism of action that could potentially provide benefits beyond current therapies. UCB0022 is designed to be administered orally, offering convenience while aiming to address symptoms differently than traditional dopamine-focused treatments. This innovative approach holds promise for improving quality of life for patients by potentially targeting underlying mechanisms of Parkinson's disease more effectively.

What evidence suggests that UCB0022 might be an effective treatment for Parkinson's Disease?

Research suggests that UCB0022 might help reduce movement problems in people with Parkinson's disease. One study showed that it improved movement issues in monkeys given a substance to mimic Parkinson's symptoms. UCB0022 targets a specific part of the brain to help control movement without causing the side effects that traditional treatments might. In this trial, participants will receive either UCB0022 at Dose A, UCB0022 at Dose B, or a placebo. Although data from human trials is still being gathered, these early findings offer hope that UCB0022 could be effective for people with Parkinson's.12456

Who Is on the Research Team?

UC

UCB Cares

Principal Investigator

001 844 599 2273

Are You a Good Fit for This Trial?

This trial is for adults aged 35-80 with advanced Parkinson's Disease who experience significant daily motor fluctuations and are responsive to levodopa therapy. They should be in stages I-III of disease severity, diagnosed with PD for at least 5 years, able to track their symptoms, and agree not to share study info on social media.

Inclusion Criteria

You are able to accurately record and differentiate between your Parkinson's Disease symptoms during ON and OFF states.
You accept to not disseminate personal medical details or study-related information on social media until the completion of the research.
My weight is at least 45 kg and my BMI is between 18 and 30.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive UCB0022 or placebo as an adjunctive treatment to stable dose of standard-of-care for Parkinson's Disease

10 weeks
9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Placebo
  • UCB0022
Trial Overview The trial tests UCB0022 as an add-on treatment compared to a placebo in reducing 'OFF time'—periods when standard Parkinson's medications wear off and symptoms return. Participants must be on a stable dose of standard care including levodopa.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: UCB0022-Dose BExperimental Treatment1 Intervention
Group II: UCB0022-Dose AExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials
118
Recruited
23,200+

Jean-Christophe Tellier

UCB Biopharma SRL

Chief Executive Officer since 2015

MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD

Dr. Iris Loew-Friedrich

UCB Biopharma SRL

Chief Medical Officer since 2014

MD from University of Leuven, PhD in Medical Sciences from University of Leuven

Published Research Related to This Trial

In a study involving 484 dyskinetic Parkinson's disease patients, it was found that placebo treatment can lead to significant improvements in dyskinesia, with 178 patients showing improvement and 37 experiencing worsening symptoms.
Factors such as older age, lower baseline Parkinsonism scores, and lower daily doses of levodopa were linked to better responses to placebo, while lower baseline dyskinesia scores were associated with worsening, suggesting that the placebo effect in dyskinesia may not be related to dopaminergic activity.
Placebo influences on dyskinesia in Parkinson's disease.Goetz, CG., Laska, E., Hicking, C., et al.[2018]
The placebo effect can lead to real improvements in motor performance for Parkinson's disease patients, as shown by studies that document increased dopamine release in key brain areas when patients believe they are receiving effective treatment.
Neuroimaging and single-neuron recordings have identified specific brain regions, such as the subthalamic nucleus and substantia nigra, that are involved in the placebo response, highlighting the complex interplay between belief, emotion, and motor function in this condition.
Characterization of the thalamic-subthalamic circuit involved in the placebo response through single-neuron recording in Parkinson patients.Frisaldi, E., Carlino, E., Lanotte, M., et al.[2022]
In a review of 11 clinical trials involving 858 Parkinson's disease patients, a positive placebo response was observed in 16% of participants, with higher baseline motor scores and studies involving motor fluctuations showing increased odds of improvement.
Placebo responses were consistent across different follow-up periods (early, mid, and late), suggesting that these responses are a significant factor in Parkinson's disease trials and should be considered in study designs.
Placebo response in Parkinson's disease: comparisons among 11 trials covering medical and surgical interventions.Goetz, CG., Wuu, J., McDermott, MP., et al.[2022]

Citations

NCT06055985 | A Study to Evaluate the Efficacy, Safety, ...The primary purpose of this study is to demonstrate the superiority of UCB0022 as an adjunctive treatment to stable dose of standard-of-care (SoC)
UCB0022Parkinson's Disease, A Study to Test the Safety, Tolerability, and Blood Levels of UCB0022 in Healthy Participants and Participants With Parkinson's Disease ...
UCB0022 for Parkinson's Disease (ATLANTIS Trial)The research highlights that placebo treatments can lead to improvements in Parkinson's disease symptoms, suggesting that patient expectations and psychological ...
A Study to Evaluate the Efficacy, Safety, Tolerability, and ...The primary purpose of this study is to demonstrate the superiority of UCB0022 as an adjunctive treatment to stable dose of standard-of-care (SoC)
glovadalen (UCB0022) / UCBUCB0022 is a selective and potent D1PAM, able to improve motor disability in MPTP-treated macaques as effectively as levodopa, but with reduced severity of ...
Testing D1 Receptor Modulator Glovadalen in Phase 2 ...Newly presented data from the phase 2 ATLANTIS study (NCT06055985) of glovadalen in showed that the therapy improved OFF time in patients with ...
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