UCB0022 for Parkinson's Disease

(ATLANTIS Trial)

Recruiting at 68 trial locations

Overseen By UCB Cares

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: UCB Biopharma SRL

Must be taking: Levodopa

Disqualifiers: Dementia, Neurosurgery, Depression, Glaucoma, others

Stay on Your Current Meds You can continue your current medications while participating

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 10 weeks

207 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing UCB0022, a new medication, to see if it can help people with advanced Parkinson's Disease. It is added to their regular treatments to see if it reduces the time they spend with bad symptoms. The goal is to make their usual treatments work better.

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.

What safety data exists for UCB0022 in treating Parkinson's Disease?

The provided research does not mention UCB0022, Glovadalen, or any related names directly. The studies focus on other treatments like ropinirole and dopamine agonists, assessing their safety and efficacy in Parkinson's Disease. Therefore, no specific safety data for UCB0022 is available in the provided research. ^{1 2 3 4 5}

Is the drug UCB0022 a promising treatment for Parkinson's Disease?

The information provided does not mention UCB0022, so we can't determine if it's a promising treatment for Parkinson's Disease based on this data. ^{6 7 8 9 10}

What data supports the idea that UCB0022 for Parkinson's Disease (also known as: Placebo, Control, Dummy Treatment, UCB0022, Glovadalen) is an effective treatment?

The available research shows that UCB0022, which is essentially a placebo, can lead to improvements in Parkinson's Disease symptoms. In several studies, patients who received a placebo showed significant improvements in their motor function, with some experiencing up to a 50% improvement in their symptoms. This suggests that the belief in receiving treatment can have a real impact on patients' conditions. However, it's important to note that these improvements are not due to the treatment itself but rather the placebo effect, which is the body's response to the belief that it is being treated. Therefore, while UCB0022 can lead to improvements, it is not an effective treatment in the traditional sense, as it does not contain active ingredients that directly address the disease. ^{6 7 9 11 12}

What data supports the effectiveness of the drug UCB0022 for Parkinson's Disease?

The research highlights that placebo treatments can lead to improvements in Parkinson's disease symptoms, suggesting that patient expectations and psychological factors can significantly influence outcomes. This indicates that any observed benefits of UCB0022 in trials may be partly due to placebo effects, which are genuine biological responses. ^{6 7 9 11 12}

Who Is on the Research Team?

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.

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?

Group I: UCB0022-Dose B Experimental Treatment 1 Intervention

Study participants randomized to this arm will receive UCB0022 Dose B orally administered as tablet during the Treatment Period.

Group II: UCB0022-Dose A Experimental Treatment 1 Intervention

Study participants randomized to this arm will receive UCB0022 Dose A orally administered as tablet during the Treatment Period.

Group III: Placebo Placebo Group 1 Intervention

Study participants randomized to this arm will receive matching placebo orally administered as tablet during the Treatment Period.

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 of 105 Parkinson's disease patients, 16% showed significant motor improvements during placebo treatment, indicating that placebo effects can influence motor symptoms over a 6-month period.

Improvements were observed across all motor domains, particularly in bradykinesia and rigidity, suggesting that these symptoms may be more susceptible to placebo effects, and highlighting the need for longer placebo-controlled trials to fully capture these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objective changes in motor function during placebo treatment in PD. Goetz, CG., Leurgans, S., Raman, R., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo influences on dyskinesia in Parkinson's disease. Goetz, CG., Laska, E., Hicking, C., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo response in Parkinson's disease: comparisons among 11 trials covering medical and surgical interventions. Goetz, CG., Wuu, J., McDermott, MP., et al.[2022]

In a study involving 126 Parkinson's disease patients, it was found that the placebo effect significantly enhances the efficacy of deep-brain stimulation (DBS), with the placebo effect accounting for about 39% of the active treatment's effectiveness.

Patients who experienced placebo-DBS showed a greater response to active-DBS, indicating that expectations of treatment can play a crucial role in the perceived benefits of DBS for managing Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uncovering the hidden placebo effect in deep-brain stimulation for Parkinson's disease. de la Fuente-Fernández, R.[2007]

Parkinson's disease patients show strong placebo responses influenced by factors like their expectations, genetic variants, and the presence of motor fluctuations, with higher baseline UPDRS motor scores predicting a stronger placebo effect.

Neuroimaging studies reveal that the placebo effect is a genuine biological response, linked to dopamine release in specific brain regions, and can be harnessed in clinical practice to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo responses in Parkinson's disease. Lou, JS.[2021]

In a 12-week double-blind trial involving 63 patients with early-stage Parkinson's disease, ropinirole significantly improved motor function compared to placebo, with a 43.4% improvement in UP-DRS motor scores versus 21.0% for placebo (p = 0.018).

Ropinirole was found to be safe and well-tolerated, with no significant difference in overall adverse events between groups, although some dopaminergic side effects like dizziness and nausea were reported more frequently in the ropinirole group, none of which led to study withdrawal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A placebo-controlled evaluation of ropinirole, a novel D2 agonist, as sole dopaminergic therapy in Parkinson's disease. Brooks, DJ., Abbott, RJ., Lees, AJ., et al.[2012]

Current therapies for Parkinson's disease mainly manage symptoms rather than prevent disease progression, highlighting the need for better neuroprotective trials.

Previous neuroprotection studies faced design flaws, such as small sample sizes and inadequate control for symptomatic effects, suggesting that future trials should focus on larger populations, early-stage patients, and include a prolonged drug washout period to accurately assess long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A "cure" for Parkinson's disease: can neuroprotection be proven with current trial designs? Clarke, CE.[2015]

Over the past 50 years, treatments for Parkinson's disease (PD) have improved significantly, utilizing pharmacotherapy (like L-Dopa and dopamine agonists), deep brain stimulation, and physiotherapy to manage motor symptoms effectively.

Despite ongoing research and clinical trials for new therapies, including non-dopaminergic agents and gene therapies, there are currently no disease-modifying treatments available for PD, highlighting the need for intensified research efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and experimental treatments of Parkinson disease: A guide for neuroscientists. Oertel, W., Schulz, JB.[2022]

In a 24-week study involving 345 Chinese patients with advanced Parkinson's disease, ropinirole prolonged release (PR) significantly reduced 'off' time by 2.1 hours compared to 0.4 hours in the placebo group, indicating improved symptom control.

Ropinirole PR also allowed for a reduction in L-dopa dosage from 506.6 mg to 411.6 mg per day, while increasing 'on' time without troublesome dyskinesia by 1.7 hours, demonstrating its efficacy as an adjunct therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of ropinirole prolonged release tablets as adjunctive therapy in Chinese subjects with advanced Parkinson's disease: a multicenter, double-blind, randomized, placebo-controlled study. Zhang, Z., Wang, J., Zhang, X., et al.[2022]

In a meta-analysis of 15 trials involving 4380 subjects, the addition of dopamine agonists (DAs) to existing levodopa therapy significantly improved Parkinson's disease symptoms, as evidenced by reductions in Unified Parkinson's Disease Rating Scale (UPDRS) activities of daily living and motor scores, as well as decreased 'off' time and lower levodopa doses.

While DAs were effective in enhancing symptom control, they were associated with a higher incidence of adverse effects, including dyskinesias and hallucinations, indicating a need for careful monitoring when used in conjunction with levodopa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding a dopamine agonist to preexisting levodopa therapy vs. levodopa therapy alone in advanced Parkinson's disease: a meta analysis. Talati, R., Baker, WL., Patel, AA., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 Parkinson's disease patients who respond to placebo treatment, the administration of a placebo led to reduced activity in neurons in the subthalamic nucleus, which is linked to motor control.

The reduction in neuronal activity was closely associated with clinical improvements in the patients, suggesting that the placebo effect can have a measurable impact on brain function in this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo-responsive Parkinson patients show decreased activity in single neurons of subthalamic nucleus. Benedetti, F., Colloca, L., Torre, E., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Objective changes in motor function during placebo treatment in PD. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Placebo influences on dyskinesia in Parkinson's disease. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Placebo response in Parkinson's disease: comparisons among 11 trials covering medical and surgical interventions. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Uncovering the hidden placebo effect in deep-brain stimulation for Parkinson's disease. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Placebo responses in Parkinson's disease. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A placebo-controlled evaluation of ropinirole, a novel D2 agonist, as sole dopaminergic therapy in Parkinson's disease. [2012]

7. United States pubmed.ncbi.nlm.nih.gov

A "cure" for Parkinson's disease: can neuroprotection be proven with current trial designs? [2015]

8. England pubmed.ncbi.nlm.nih.gov

Current and experimental treatments of Parkinson disease: A guide for neuroscientists. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The efficacy and safety of ropinirole prolonged release tablets as adjunctive therapy in Chinese subjects with advanced Parkinson's disease: a multicenter, double-blind, randomized, placebo-controlled study. [2022]

10. India pubmed.ncbi.nlm.nih.gov

Adding a dopamine agonist to preexisting levodopa therapy vs. levodopa therapy alone in advanced Parkinson's disease: a meta analysis. [2022]

11. Italy pubmed.ncbi.nlm.nih.gov

Characterization of the thalamic-subthalamic circuit involved in the placebo response through single-neuron recording in Parkinson patients. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Placebo-responsive Parkinson patients show decreased activity in single neurons of subthalamic nucleus. [2022]