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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)
Awards & highlights

ATLANTIS Trial Summary

This trial will test a new medication versus placebo to reduce time spent in an "OFF" state for people with advanced Parkinson's Disease.

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.Check my eligibility
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.See study design
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.

ATLANTIS Trial 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.
Select...
I am between 35 and 80 years old.

ATLANTIS Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

ATLANTIS 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

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
102 Previous Clinical Trials
21,414 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273
205 Previous Clinical Trials
44,774 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacant positions in this experiment for individuals to join?

"Per the information on clinicaltrials.gov, this study is actively recruiting patients as of now; it was posted initially on November 21st 2023 and recently edited on the day before that."

Answered by AI

Can I partake in this scientific experiment?

"This clinical trial is targeting 189 individuals aged 35-80 with Parkinson's disease. To be eligible, participants must also: possess a BMI between 18 and 30 kg/m^2; demonstrate Stages I-III of PD severity during their ON state; complete daily symptom diaries to differentiate the OFF from the ON states; receive oral doses of levodopa in combination with carbidopa or benserazide (with potential adjunctive therapies); not post any personal medical data related to this study on social media until completion; weigh over 45kg for males and agree to use contraception while taking part in the treatment period as well as"

Answered by AI

Is UCB0022-Dose B considered a safe option for people?

"Leveraging our team's experience, UCB0022-Dose B was given a rating of 2 on the safety scale. This is due to it being in Phase 2 at present, so there are some data points that confirm its security but none regarding efficacy."

Answered by AI

Does this research include elderly participants?

"The requirements for this study state that participants must be between 35-80 years old. Additionally, there are a total of 24 trials catered towards minors and 543 studies suitable for those over 65."

Answered by AI

How many test subjects are involved in this research endeavor?

"Affirmative. Clinicaltrials.gov data indicates that this medical research is in the process of seeking participants, having been posted on November 21st 2023 and modified most recently on November 20th 2023. This clinical trial needs to recruit 189 patients from a single site."

Answered by AI

Who else is applying?

What site did they apply to?
Pd0060 50620
Pd0060 50603
Pd0060 50613
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

What questions have other patients asked about this trial?

How many screening visits and how long do they last?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I’m newly diagnosed and am looking for best possible treatments. I am newly diagnosed with Parkinson’s disease. I am interested in medical trials.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease
2023. "A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06055985.
All > Indianapolis > Spokane
~110 spots leftby Dec 2024
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