Now enrolling adults ages 35 to 80 diagnosed with Parkinson’s disease for at least 5 years with fluctuating motor symptoms
The ATLANTIS Study is a clinical research study to evaluate an oral investigational medication called UCB0022 in participants living with advanced Parkinson’s disease (diagnosed 5 or more years ago and significant motor fluctuations with at least 2 cumulative OFF hours per day).
Participants will be randomly assigned to receive 1 of 2 possible daily doses of UCB0022 or placebo, which is a once-daily oral formulation taken in addition to participants’ stable-dose standard of care.
To be eligible for the ATLANTIS Study, participants must:
- Be between 35 and 80 years of age
- Have been diagnosed with Parkinson’s disease 5 or more years ago
- Have significant daily motor fluctuation (at least 2 hours/day of cumulative OFF time daily despite adequate antiparkinsonian pharmacological therapy)
- Be 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
- Be willing to complete a 3-day symptom diary at four time points during the study
Participants are not eligible if they:
- Have a history of neurosurgical intervention for PD (including deep brain stimulation, thalamotomy, and experimental cell therapy or gene therapy)
- Are using parenteral device-aided administration of antiparkinsonian medication (e.g. 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
- 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 at Screening
The ATLANTIS Study will last up to a total of 18 weeks per participant.
During an initial Screening Period, participants will undergo a series of procedures and assessments to determine their eligibility for the ATLANTIS Study.
Once eligibility is confirmed, qualified participants will enter the Treatment Period and be randomized 1:1:1 to one of the following treatment groups:
- UCB0022 lower dose
- UCB0022 higher dose
- Placebo
During the study, participants will continue with their stable-dose standard of care, which should include at least levodopa combination therapy (i.e. levodopa/carbidopa or benserazide/levodopa).
Participants will return for one safety follow-up visit after the last dose of the investigational medication or placebo.
At four time points during the study, participants will record their “ON” and “OFF” state at home in a symptoms diary. Participants will also be asked to complete a number of different ePROs, some of which can be completed remotely. Care partners 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 movement throughout the study while participants are awake and sleeping.
Frequently asked questions
The ATLANTIS Study is sponsored by UCB, a global biopharma company focusing on neurological and immunological conditions, including movement disorders such as Parkinson’s disease.
UCB is offering the option of a concierge service for travel support to participants and their care partner to and from the study site, as well as reimbursement for reasonable study-related expenses and a stipend may also be paid.
The “Find a Study Center” section of this website offers functionality to locate all activated and upcoming study sites across the United States to reach out to for more information and instructions on how to join the study.
Study sites will be seeing study participants for the duration of the study but are encouraged to refer them back into the care of their regular physicians after they conclude their participation in the study. Study participants can of course also see their regular physicians for routine appointments. Please note that certain medications are prohibited during the study, thus additional concomitant medications or adjustments to medications should always be discussed with the study site first.
Those taking part in the ATLANTIS Study may not directly benefit from their participation. However, their participation will contribute to a better understanding of the investigational medication, UCB0022, and its effects in patients with advanced Parkinson's disease. It could make a difference in better understanding how to treat Parkinson’s disease in the future.
