The ATLANTIS Study is testing an investigational medication called UCB0022 in Parkinson’s disease (PD).
The aim of the study is to find out more about the drug called UCB0022. More specifically, it will assess its effectiveness, safety, tolerability (type and amount of side effects) and pharmacokinetics (how the medication is processed in the body). UCB0022 will be given alongside standard PD medications.
The study will compare two different doses of UCB0022 to a placebo, which looks like the investigational medication but contains no medicinally active ingredients. That means during the study you will receive either 1 of the 2 doses of UCB0022 or the placebo. Both UCB0022 and the placebo are provided as tablets that are taken every morning by mouth.
To be able to join the ATLANTIS Study, you must:
- Be between 35 and 80 years of age
- Have been diagnosed with Parkinson’s disease 5 or more years ago
- Be experiencing daily motor fluctuations (at least 2 cumulative hours of “OFF” time every day when Parkinson’s disease symptoms return after the medication has worn off)
- Currently be receiving treatment with levodopa (with or without additional therapies for Parkinson’s disease)
- Be willing to complete a 3-day symptom diary at four time points during the study
You cannot participate in the study if you:
- Have had brain surgery for PD (including deep brain stimulation, thalamus surgery, and experimental cell therapy or gene therapy)
- Are using parenteral PD medication (medication that is infused or injected like duopa/duodopa or apomorphine)
- Have a diagnosis of dementia, other forms of important cognitive dysfunction, epilepsy or another seizure disorder
- Have a history or current diagnosis of Type 1 diabetes or uncontrolled Type 2 diabetes or have current untreated hypertension (high blood pressure)
- Have had major depression or psychotic disorder or any other psychiatric condition within the past 5 years
- Have a history of alcohol or drug use disorder
- Have a positive drug/alcohol test, HIV test or hepatitis B test when you join the study
Other criteria will need to be met in order to participate in this study. Your study team will discuss these with you.
Click here if you’re interested in joining the study.
Participation in the ATLANTIS Study will last up to a little over 4 months and will involve a total of 10 visits to the study site.
During Screening, the study doctor will perform several tests and assessments to confirm you meet all the study criteria. Provided you can continue in the study, you will then begin the Treatment Period. After the Treatment Period, you move into the Safety Follow-up Period where you will have a follow-up visit after you stopped taking the study medication.
The assessments performed during the study can include:
- Discussing your medical history
- Discussing your current medications
- Having physical and neurological examinations
- Having your vital signs taken (blood pressure, pulse, breathing rate, and body temperature)
- Having your height and weight measured
- Providing blood and urine samples for laboratory testing
- Having an ECG to check your heart’s activity
- Completing questionnaires
Your study team and an informed consent document you will receive will tell you more about the different study visits and what exactly happens during these visits.
During the ATLANTIS Study, we will compare two different doses of UCB0022 to a placebo in addition to your regular medication(s) for Parkinson’s disease. A placebo looks like the UCB0022 medication but contains no medicinally active ingredients. The study medication is taken by mouth as tablets once a day.
You will be randomly assigned (like drawing straws) to one of three possible study treatment groups. There is a:
- 1 in 3 chance that you will receive the lower dose of UCB0022
- 1 in 3 chance that you will receive the higher dose of UCB0022
- 1 in 3 chance that you will receive a placebo
The ATLANTIS study is blinded, which means that neither you, your care partner, nor the study team will know or be able to decide whether you will be receiving UCB0022 or a placebo during the ATLANTIS Study.
On four occasions during the study you will be asked to record your Parkinson’s disease symptoms for three consecutive days in a simple and easy to complete paper document (study diary) you will be given. These diary entries are important in showing if there are, or are not, any changes in symptoms while you are taking the study medication.
You will also be asked to fill out some questionnaires at home on two occasions. These will be completed electronically on a tablet computer. If you have a care partner, he or she will be asked to complete a questionnaire about their experience of what it’s like to care for someone with PD.
The study uses a wrist-worn device very similar to a normal smartwatch that automatically records movements and motor symptoms. This device will be given to patients who are 46 years or older and needs to be given back after the study ends. It monitors your movement throughout the study while you are awake and sleeping.
You and your care partner will have the option of travel support to and from your study visits, as well as being reimbursed for reasonable expenses and a stipend may also be paid.
The interactive map shows the study centers that are participating in the ATLANTIS Study. Currently active study centers are listed with address and contact details, centers that are not yet active are marked as “coming soon”. If a “coming soon” center is a center near you, we recommend you check back later to see if it has become active in the meantime. You can email and/or call the active study centers to learn more about the study and how to participate. There is no obligation to join — you and your care partner can decide if the study is right for you.
If you have any further questions about how to participate in the ATLANTIS Study you can contact UCBCares® via phone on 844-599-CARE (2273) or email us at ucbCARES@ucb.com.
Please select the study center that is most convenient for you.
Take the questionnaire
The following questions are designed to help find out whether a potential participant may be eligible for participation in the ATLANTIS Study.
Thank you for completing this brief study questionnaire.
Unfortunately, based on your responses, you don’t meet the criteria to join the ATLANTIS Study at this time. Please speak to your regular doctor(s) about what treatment options are available to you.
Thank you for completing this brief study questionnaire.
It looks like you could be a candidate to take part in the study. Please contact the study center directly to find out more.
The ATLANTIS Study is what is called a clinical research study or a clinical trial. Clinical research is carefully supervised research that is necessary in order to determine whether a study medication can become available to the public. These studies help doctors and researchers find out more about how a study medication may or may not work. It can also help finding out how well it is tolerated, and how the study medication is transported around and processed by the human body. Every medication should be tested and then approved by regulatory health authorities before the general public is able to use it and doctors are able to prescribe or recommend it to their patients.
- Clinical studies follow specific rules to protect the rights, safety, well-being, and privacy of participants.
- The results help government officials decide if a medication or product is safe and should be available to patients.
- Clinical studies are the only way to develop new medical treatments.
Together with patient organizations such as the Parkinson’s Foundation in the US and Parkinson’s UK, this study has had direct involvement from people with Parkinson’s disease and Parkinson’s care partners through advisory panels, document reviews and surveys. This collaboration has helped to better tailor the study to meet the needs of people with Parkinson’s and their care partners.
Below are links to organizations that may be of help to you on your journey with Parkinson’s disease.
- Parkinson's Foundation - https://www.parkinson.org/
- Michael J. Fox Foundation - https://www.michaeljfox.org/
- Davis Phinney Foundation - https://davisphinneyfoundation.org/
Frequently asked questions
The ATLANTIS Study is a phase 2 study, which means that more studies will have to follow after this one to find out more about UCB0022 before it can be submitted to regulatory authorities for approval for public use.
The symptoms of Parkinson’s disease happen because people with PD don’t have enough dopamine in the brain. The study medication UCB0022 is a substance that works in a way that it affects how dopamine, or medications that act like dopamine, are being made available in the brain. We are testing UCB0022 to find out whether it has an effect on the overall time spent in an “OFF” state (when symptoms return because PD medication has worn off).
During the study, you will have to undergo some tests and procedures, including but not limited to:
- Discussing your medical history
- Discussing your current medications
- Having physical and neurological examinations
- Having your vital signs taken (blood pressure, pulse, breathing rate, and body temperature)
- Having your height and weight measured
- Providing blood and urine samples for laboratory testing
- Having an ECG to check your heart’s activity
- Completing questionnaires
- Recording your PD symptoms in an easy to complete paper document (study diary)
No, because the ATLANTIS Study is a blinded study. You will not be able to choose whether you receive UCB0022 or a placebo.
In the ATLANTIS Study you and your care partner will have the option of travel support to and from your study visits, as well as being reimbursed for reasonable study-related expenses and a stipend may also be paid.
As with all medicines, the medication tested in the ATLANTIS Study can have side effects. You will receive detailed information on what side effects of the study drug are already known from previous studies and your study doctor will talk to you about the risks and benefits of the study for you and your care partner.
Your symptoms may or may not change during the study, and taking the study medication is not a guarantee your symptoms will improve. Throughout the study, your health and well-being is paramount and will be closely monitored.
Participation in the ATLANTIS Study is completely up to you. Deciding not to take part will not affect your medical care by the study team or your other doctors, now or in the future. If you take part, you can decide to leave the study at any time without giving a reason and without any negative effects to your medical care or the relationship with your doctors.
After you leave the study, you will only be able to access UCB0022 after it has been approved for public use by the FDA (the US health authority). This can be a lengthy process and can take several years.
There are many reasons to participate in clinical research. During this clinical study, your health and your Parkinson’s disease will be closely monitored. Study participants also play an important part in bringing new medications to market, which can benefit many other people in the future who also have the disease or condition.
Every clinical study must be reviewed by an independent review committee to ensure the risks are as low as possible and are worth any potential benefits to the study participant. As a volunteer, you have the right to stop your participation and leave the study at any time and for any reason, with no penalty or loss of benefits which you are otherwise entitled to.
Any data collected during the study will not identify you directly and will be handled as strictly confidential. Your identity will not be revealed in any publication or report generated from this study. The Informed Consent Form you will be given and asked to sign before joining the study has more detailed information about study-related data handling and privacy in it.
The ATLANTIS Study is sponsored by a global biopharma company called UCB Biopharma SRL. UCB puts a strong focus on neurological and immunological conditions, including movement disorders such as Parkinson’s disease.
