What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease, particularly those used as adjunctive therapies to reduce motor fluctuations, include levodopa and its adjuncts. Levodopa can cause nausea, dizziness, headache, somnolence, confusion, hallucinations, delusions, agitation, psychosis, and orthostatic hypotension. Dopamine agonists like pramipexole and ropinirole may lead to similar side effects and compulsive behaviors. MAO-B inhibitors such as rasagiline and selegiline are generally well-tolerated but can cause insomnia and hypertensive reactions. Amantadine can result in confusion, orthostatic hypotension, and hallucinations.

What prior FDA approvals exist?

Several FDA-approved drugs are used as adjunctive treatments to reduce motor fluctuations in Parkinson's Disease. These include MAO-B inhibitors like rasagiline and selegiline, which help to extend the effect of levodopa. Dopamine agonists such as pramipexole, ropinirole, and rotigotine are also used to provide more consistent dopaminergic stimulation. Additionally, COMT inhibitors like entacapone and tolcapone are used to prolong the effect of levodopa by inhibiting its breakdown. These treatments aim to reduce 'OFF' time and improve motor function in patients experiencing fluctuations.

What other types of research exist?

Promising alternatives to UCB0022 for reducing motor fluctuations in Parkinson's Disease include: 1) Ropinirole, a nonergot dopamine agonist, which has shown efficacy as an adjunct to levodopa in reducing motor fluctuations. 2) Preladenant, an adenosine 2A antagonist, which has demonstrated a reduction in daily 'OFF' time in patients on stable doses of levodopa. 3) COMT inhibitors like entacapone and tolcapone, which have been shown to increase 'ON' time and decrease 'OFF' time in patients with motor fluctuations. 4) Extended-release carbidopa-levodopa (IPX066), which has been found to reduce 'OFF' time compared to immediate-release formulations.

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UCB0022 for Parkinson's Disease (ATLANTIS Trial)

Phase 2

Recruiting

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 is diagnosed with Parkinson's disease (PD) (based on the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic criteria performed at the Screening Visit) and diagnosed ≥5 years before the Screening Visit (based on historical medical- information documented by the investigator)

Study participant is responsive to levodopa and currently receiving treatment with oral daily doses of levodopa combination (levodopa/carbidopa or levodopa/benserazide) with or without oral adjunctive antiparkinsonian therapies (based on historical clinical data)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (day 1) to visit 9 (day 70)

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, common ones associated with Parkinson's treatments include nausea, dizziness upon standing, sleepiness, hallucinations or other psychiatric effects.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Parkinson's disease for over 5 years.

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I respond to levodopa for Parkinson's and take it daily with or without other Parkinson's medications.

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My weight is at least 45 kg and my BMI is between 18 and 30.

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I am not able to become pregnant.

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I experience significant changes in my ability to move each day.

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My condition is in the early to mid stages (I-III) when my medication is working.

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I am between 35 and 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (day 1) to visit 9 (day 70)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (day 1) to visit 9 (day 70)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) to visit 9 (day 70) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from Baseline to Visit 9 (Day 70) in the average number of hours/day of OFF time, as assessed by the study participant-completed Hauser PD symptoms diary over 3 consecutive days

Secondary study objectives

Average Ctrough of UCB0022 and its active N-desmethyl-UCB0022 metabolite at Visit 9 (Day 70)

Incidence of TEAEs leading to withdrawal from the study

Incidence of treatment-emergent adverse events (TEAEs)

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: UCB0022-Dose BExperimental Treatment1 Intervention

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

Group II: UCB0022-Dose AExperimental Treatment1 Intervention

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

Group III: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

UCB0022

2021

Completed Phase 1

~100

0 / 7Eligibility 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

Common treatments for Parkinson's Disease (PD) primarily focus on dopaminergic therapies. Levodopa, a dopamine precursor, replenishes brain dopamine levels, directly addressing the deficiency. Dopamine agonists stimulate dopamine receptors, mimicking dopamine's effects to reduce motor symptoms and fluctuations. MAO B inhibitors prevent dopamine breakdown, increasing its availability. These treatments are essential for PD patients as they help manage motor symptoms and fluctuations, improving overall quality of life. The trial UCB0022 is investigating an adjunctive treatment to further reduce motor fluctuations, aiming for more consistent symptom control.

Dopamine agonists in Parkinson's disease.Initial agonist treatment of Parkinson disease: a critique.