Parkinson DiseaseNCT06834191
Relationship Between Immunosuppressive Treatment Status and Clinical Course of Parkinson's Disease
An observational study of Parkinson Disease, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The goal of this observational study is to learn if immunosuppressive drug treatment influences the clinical course of Parkinson's disease. Recent research suggests that Parkinson's disease may have an inflammatory background. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2025to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will be recruited among patients of the Department of Neurology and Parkinsonism Clinic of the Faculty of Health Sciences, Medical University of Warsaw, Warsaw, Poland
Who may be able to join
- Diagnosis of Parkinson's disease according to the International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease;
- Immunosuppressive medication use - medication taken regularly, which we have defined as administered at a dose and frequency effective for the indicated disease, for over 12 months, systemic administration route (oral, intramuscular, subcutaneous, intravenous and inhaled); The most commonly used immunosuppressive drugs that we anticipate will be used by the study group participants include: glucocorticosteroids (GC) - budesonide, cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, triamcinolone; calcineurin inhibitors - tacrolimus, cyclosporine; inosine monophosphate dehydrogenase (IMDH) inhibitors - azathioprine, leflunomide, mycophenolate; mammalian target of rapamycin (mTOR) inhibitors - sirolimus, everolimus; biologics - abatacept, adalimumab, anakinra, certolizumab, etanercept, infliximab, ixekizumab, natalizumab, rituximab, secukinumab, tocilizumab, ustekinumab, vedolizumab; antimetabolites - methotrexate; inclusion of participants taking immunosuppressive drugs not listed above will be considered individually;
- Provision of informed consent to participate in the study.
- Diagnosis of Parkinson's disease according to the International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease;
- No history of regular use of immunosuppressive medications;
- Provision of informed consent to participate in the study.
Who cannot join
- Immunosuppressive drug administration at an ad hoc basis (i.e. when symptoms occur) or irregularly (i.e. drug taken at an inappropriate dose and/or with a regularity ineffective for the indicated disease);
- Use of immunosuppressive drugs for a period of less than 12 months;
- Ineffective treatment of the disease requiring the use of immunosuppressive drugs (no improvement/progression of disease symptoms);
- Additional exclusion criteria for both the study and control groups:
- Advanced cancer; severe heart failure; severe renal failure; untreated autoimmune disease; active inflammation; diseases that impair drug absorption/metabolism;
- Dementia;
- Failure/inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Neurology, Faculty of Health Science, Medical University of Warsaw
Warsaw, 02-091
Monika Figura, MD, PhD, +48223265427, monika.figura@wum.edu.pl
About this study
Official title: Analysis of the Relationship Between Immunosuppressive Treatment Status and Clinical Course of Parkinson's Disease
The goal of this observational study is to learn if immunosuppressive drug treatment influences the clinical course of Parkinson's disease. Recent research suggests that Parkinson's disease may have an inflammatory background. Numerous studies have identified elevated levels of pro-inflammatory markers in people with Parkinson's disease. Therefore, immunosuppressive drugs may potentially affect the course of this disease.
The investigators will recruit people with Parkinson's disease, who receive long-term immunosuppressive treatment for other chronic illnesses, into the study group. The study will also recruit people with Parkinson's disease with no history of immunosuppressive drug treatment into the control group. The main question this study aims to answer is:
Read more
> Does immunosuppressive drug treatment slow down the onset and/or progression of Parkinson's disease?
Researchers will compare Parkinson's disease progression rates and serum inflammatory marker levels between the study and control group, to see if immunosuppressive drug treatment influences the course of Parkinson's disease.
The study requires each participant to attend one hospital appointment. This appointment will be approximately one hour long, and will involve:
- clinical Parkinson's disease motor assessments conducted by the research team -> participants will be evaluated in the OFF state, meaning they will not have taken their Parkinson's disease medication the day of the assessment;
- completion of Parkinson's disease symptom scales;
- a one-time serum sample collection;
- detailed medical history obtainment from the participant by the research team, with a primary focus on the patient's immunosuppressive treatment history and individual clinical course of Parkinson's disease.
- Conditions
- Parkinson Disease
- Keywords
- Immunosuppression, Immunosuppressive treatment, cross-sectional study, observational study, Parkinson disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People with Parkinson's receiving long - term immunosuppressive treatment - study group | Not described | |
| People with Parkinson's without long-term immunosuppressive treatment history - control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual motor progression rate - Unified Parkinson's Disease Rating Scale PART III OFF
This primary outcome will measure annual Parkinson's disease motor symptom progression rates using Part III (Motor Examination) of the Unified Parkinson's Disease Rating Scale (UPDRS). Assessments will be conducted in the OFF state, meaning the participant will not have taken any Parkinson's disease medication the day of the assessment. Part III of the UPDRS contains 18 items, the minimum value of UPDRS Part III is 0 points, and the maximum value is 132 points. In UPDRS Part III the higher the score, the worse the outcome. Annual progression rates will be calculated based on the time from the participant's motor symptom onset to the time of the appointment.
Measured: Day 1
Annual LEDD increase rate
This secondary outcome will measure annual Parkinson's disease levodopa equivalent daily dose (LEDD) increase rates for each participant. Parkinson's disease medication taken by the participant will be procured at each participant's individual appointment. LEDD values will then be calculated based on the doses and types of Parkinson's disease medication taken by the participant. Annual LEDD rates will be calculated based on the LEDD value and time from the participant's motor symptom onset to the time of the appointment.
Measured: Day 1
Age of motor symptom onset
This secondary outcome will measure the age of onset of Parkinson's disease motor symptoms.
Measured: Day 1
Secondary outcomes (6)
Annual motor progression rate - Hoehn and Yahr scale
This primary outcome will measure annual Parkinson's disease motor symptom progression rates using the Hoehn and Yahr scale. This scale is used for staging functional disability associated with Parkinson's disease. The stages range from 1 to 5, and the higher the score the worse the outcome. Annual progression rates will be calculated based on the time from the participant's motor symptom onset to the time of the appointment.
Measured: Day 1
Annual motor progression rate - Unified Parkinson's Disease Rating Scale PART II
This primary outcome will measure annual Parkinson's disease motor symptom progression rates using Part II (Motor Aspects of Experiences of Daily Living ) of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Part II of the MDS-UPDRS contains 13 items, the minimum value of MDS-UPDRS Part II is 0 points, and the maximum value is 52 points. In UPDRS Part II the higher the score, the worse the outcome. Annual progression rates will be calculated based on the time from the participant's motor symptom onset to the time of the appointment.
Measured: Day 1
Serum inflammatory marker levels - IL-1β
This secondary outcome measures the level of IL-1β in each participant at a single time-point.
Measured: Day 1
Serum inflammatory marker levels - IL-6
This secondary outcome measures the level of IL-6 in each participant at a single time-point.
Measured: Day 1
Serum inflammatory marker levels - calprotectin
This secondary outcome measures the level of calprotectin in each participant at a single time-point.
Measured: Day 1
Serum inflammatory marker levels - TNFα
This secondary outcome measures the level of TNFα in each participant at a single time-point.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Mar 2025
- Primary completionDec 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834191
- Sponsor's protocol ID
- KB/164/2024
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brumm MC, Siderowf A, Simuni T, Burghardt E, Choi SH, Caspell-Garcia C, Chahine LM, Mollenhauer B, Foroud T, Galasko D, Merchant K, Arnedo V, Hutten SJ, O'Grady AN, Poston KL, Tanner CM, Weintraub D, Kieburtz K, Marek K, Coffey CS; Parkinson's Progression Markers Initiative. Parkinson's Progression Markers Initiative: A Milestone-Based Strategy to Monitor Parkinson's Disease Progression. J Parkinsons Dis. 2023;13(6):899-916. doi: 10.3233/JPD-223433.
PubMed 37458046Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.
PubMed 26474316Dulski J, Heckman MG, Nowak JM, Wszolek ZK. Protective Effect of Glucocorticoids against Symptomatic Disease in CSF1R Variant Carriers. Mov Disord. 2023 Aug;38(8):1545-1549. doi: 10.1002/mds.29504. Epub 2023 Jun 13.
PubMed 37309919Racette BA, Gross A, Vouri SM, Camacho-Soto A, Willis AW, Searles Nielsen S. Immunosuppressants and risk of Parkinson disease. Ann Clin Transl Neurol. 2018 May 31;5(7):870-875. doi: 10.1002/acn3.580. eCollection 2018 Jul.
PubMed 30009205Bruggeman A, Vandendriessche C, Hamerlinck H, De Looze D, Tate DJ, Vuylsteke M, De Commer L, Devolder L, Raes J, Verhasselt B, Laukens D, Vandenbroucke RE, Santens P. Safety and efficacy of faecal microbiota transplantation in patients with mild to moderate Parkinson's disease (GUT-PARFECT): a double-blind, placebo-controlled, randomised, phase 2 trial. EClinicalMedicine. 2024 Mar 27;71:102563. doi: 10.1016/j.eclinm.2024.102563. eCollection 2024 May.
PubMed 38686220Schwiertz A, Spiegel J, Dillmann U, Grundmann D, Burmann J, Fassbender K, Schafer KH, Unger MM. Fecal markers of intestinal inflammation and intestinal permeability are elevated in Parkinson's disease. Parkinsonism Relat Disord. 2018 May;50:104-107. doi: 10.1016/j.parkreldis.2018.02.022. Epub 2018 Feb 12.
PubMed 29454662Franceschi C, Valensin S, Fagnoni F, Barbi C, Bonafe M. Biomarkers of immunosenescence within an evolutionary perspective: the challenge of heterogeneity and the role of antigenic load. Exp Gerontol. 1999 Dec;34(8):911-21. doi: 10.1016/s0531-5565(99)00068-6.
PubMed 10673145Qin XY, Zhang SP, Cao C, Loh YP, Cheng Y. Aberrations in Peripheral Inflammatory Cytokine Levels in Parkinson Disease: A Systematic Review and Meta-analysis. JAMA Neurol. 2016 Nov 1;73(11):1316-1324. doi: 10.1001/jamaneurol.2016.2742.
PubMed 27668667Brodacki B, Staszewski J, Toczylowska B, Kozlowska E, Drela N, Chalimoniuk M, Stepien A. Serum interleukin (IL-2, IL-10, IL-6, IL-4), TNFalpha, and INFgamma concentrations are elevated in patients with atypical and idiopathic parkinsonism. Neurosci Lett. 2008 Aug 22;441(2):158-62. doi: 10.1016/j.neulet.2008.06.040. Epub 2008 Jun 19.
PubMed 18582534Tansey MG, Wallings RL, Houser MC, Herrick MK, Keating CE, Joers V. Inflammation and immune dysfunction in Parkinson disease. Nat Rev Immunol. 2022 Nov;22(11):657-673. doi: 10.1038/s41577-022-00684-6. Epub 2022 Mar 4.
PubMed 35246670
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Relationship Between Immunosuppressive Treatment Status and Clinical Course of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06834191
- Acronym / sponsor ID
- KB/164/2024
- Conditions
- Parkinson Disease
- Keywords
- Immunosuppression, Immunosuppressive treatment, cross-sectional study, observational study, Parkinson disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn if immunosuppressive drug treatment influences the clinical course of Parkinson's disease. Recent research suggests that Parkinson's disease may have an inflammatory background. Numerous studies have identified elevated levels of pro-inflammatory markers in people with Parkinson's disease. Therefore, immunosuppressive drugs may potentially affect the course of this disease.
The investigators will recruit people with Parkinson's disease, who receive long-term immunosuppressive treatment for other chronic illnesses, into the study group. The study will also recruit people with Parkinson's disease with no history of immunosuppressive drug treatment into the control group. The main question this study aims to answer is:
> Does immunosuppressive drug treatment slow down the onset and/or progression of Parkinson's disease?
Researchers will compare Parkinson's disease progression rates and serum inflammatory marker levels between the study and control group, to see if immunosuppressive drug treatment influences the course of Parkinson's disease.
The study requires each participant to attend one hospital appointment. This appointment will be approximately one hour long, and will involve:
- clinical Parkinson's disease motor assessments conducted by the research team -> participants will be evaluated in the OFF state, meaning they will not have taken their Parkinson's disease medication the day of the assessment;
- completion of Parkinson's disease symptom scales;
- a one-time serum sample collection;
- detailed medical history obtainment from the participant by the research team, with a primary focus on the patient's immunosuppressive treatment history and individual clinical course of Parkinson's disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with Parkinson's receiving long - term immunosuppressive treatment - study group | – | – |
| People with Parkinson's without long-term immunosuppressive treatment history - control group | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be recruited among patients of the Department of Neurology and Parkinsonism Clinic of the Faculty of Health Sciences, Medical University of Warsaw, Warsaw, Poland
Key inclusion criteria (6 listed)
- Diagnosis of Parkinson's disease according to the International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease;
- Immunosuppressive medication use - medication taken regularly, which we have defined as administered at a dose and frequency effective for the indicated disease, for over 12 months, systemic administration route (oral, intramuscular, subcutaneous, intravenous and inhaled); The most commonly used immunosuppressive drugs that we anticipate will be used by the study group participants include: glucocorticosteroids (GC) - budesonide, cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, triamcinolone; calcineurin inhibitors - tacrolimus, cyclosporine; inosine monophosphate dehydrogenase (IMDH) inhibitors - azathioprine, leflunomide, mycophenolate; mammalian target of rapamycin (mTOR) inhibitors - sirolimus, everolimus; biologics - abatacept, adalimumab, anakinra, certolizumab, etanercept, infliximab, ixekizumab, natalizumab, rituximab, secukinumab, tocilizumab, ustekinumab, vedolizumab; antimetabolites - methotrexate; inclusion of participants taking immunosuppressive drugs not listed above will be considered individually;
- Provision of informed consent to participate in the study.
- Diagnosis of Parkinson's disease according to the International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease;
- No history of regular use of immunosuppressive medications;
Key exclusion criteria (7 listed)
- Immunosuppressive drug administration at an ad hoc basis (i.e. when symptoms occur) or irregularly (i.e. drug taken at an inappropriate dose and/or with a regularity ineffective for the indicated disease);
- Use of immunosuppressive drugs for a period of less than 12 months;
- Ineffective treatment of the disease requiring the use of immunosuppressive drugs (no improvement/progression of disease symptoms);
- Advanced cancer; severe heart failure; severe renal failure; untreated autoimmune disease; active inflammation; diseases that impair drug absorption/metabolism;
- Dementia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Annual motor progression rate - Unified Parkinson's Disease Rating Scale PART III OFF
Time frame: Day 1
This primary outcome will measure annual Parkinson's disease motor symptom progression rates using Part III (Motor Examination) of the Unified Parkinson's Disease Rating Scale (UPDRS). Assessments will be conducted in the OFF state, meaning the participant will not have taken any Parkinson's disease medication the day of the assessment. Part III of the UPDRS contains 18 items, the minimum value of UPDRS Part III is 0 points, and the maximum value is 132 points. In UPDRS Part III the higher the score, the worse the outcome. Annual progression rates will be calculated based on the time from the participant's motor symptom onset to the time of the appointment.
Annual LEDD increase rate
Time frame: Day 1
This secondary outcome will measure annual Parkinson's disease levodopa equivalent daily dose (LEDD) increase rates for each participant. Parkinson's disease medication taken by the participant will be procured at each participant's individual appointment. LEDD values will then be calculated based on the doses and types of Parkinson's disease medication taken by the participant. Annual LEDD rates will be calculated based on the LEDD value and time from the participant's motor symptom onset to the time of the appointment.
Age of motor symptom onset
Time frame: Day 1
This secondary outcome will measure the age of onset of Parkinson's disease motor symptoms.
6 secondary outcomes
Annual motor progression rate - Hoehn and Yahr scale
Time frame: Day 1
Annual motor progression rate - Unified Parkinson's Disease Rating Scale PART II
Time frame: Day 1
Serum inflammatory marker levels - IL-1β
Time frame: Day 1
Serum inflammatory marker levels - IL-6
Time frame: Day 1
Serum inflammatory marker levels - calprotectin
Time frame: Day 1
Serum inflammatory marker levels - TNFα
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Background: PubMed 37458046Brumm MC, Siderowf A, Simuni T, Burghardt E, Choi SH, Caspell-Garcia C, Chahine LM, Mollenhauer B, Foroud T, Galasko D, Merchant K, Arnedo V, Hutten SJ, O'Grady AN, Poston KL, Tanner CM, Weintraub D, Kieburtz K, Marek K, Coffey CS; Parkinson's Progression Markers Initiative. Parkinson's Progression Markers Initiative: A Milestone-Based Strategy to Monitor Parkinson's Disease Progression. J Parkinsons Dis. 2023;13(6):899-916. doi: 10.3233/JPD-223433.
- Background: PubMed 26474316Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.
- Background: PubMed 37309919Dulski J, Heckman MG, Nowak JM, Wszolek ZK. Protective Effect of Glucocorticoids against Symptomatic Disease in CSF1R Variant Carriers. Mov Disord. 2023 Aug;38(8):1545-1549. doi: 10.1002/mds.29504. Epub 2023 Jun 13.
- Background: PubMed 30009205Racette BA, Gross A, Vouri SM, Camacho-Soto A, Willis AW, Searles Nielsen S. Immunosuppressants and risk of Parkinson disease. Ann Clin Transl Neurol. 2018 May 31;5(7):870-875. doi: 10.1002/acn3.580. eCollection 2018 Jul.
- Background: PubMed 38686220Bruggeman A, Vandendriessche C, Hamerlinck H, De Looze D, Tate DJ, Vuylsteke M, De Commer L, Devolder L, Raes J, Verhasselt B, Laukens D, Vandenbroucke RE, Santens P. Safety and efficacy of faecal microbiota transplantation in patients with mild to moderate Parkinson's disease (GUT-PARFECT): a double-blind, placebo-controlled, randomised, phase 2 trial. EClinicalMedicine. 2024 Mar 27;71:102563. doi: 10.1016/j.eclinm.2024.102563. eCollection 2024 May.
- Background: PubMed 29454662Schwiertz A, Spiegel J, Dillmann U, Grundmann D, Burmann J, Fassbender K, Schafer KH, Unger MM. Fecal markers of intestinal inflammation and intestinal permeability are elevated in Parkinson's disease. Parkinsonism Relat Disord. 2018 May;50:104-107. doi: 10.1016/j.parkreldis.2018.02.022. Epub 2018 Feb 12.
- Background: PubMed 10673145Franceschi C, Valensin S, Fagnoni F, Barbi C, Bonafe M. Biomarkers of immunosenescence within an evolutionary perspective: the challenge of heterogeneity and the role of antigenic load. Exp Gerontol. 1999 Dec;34(8):911-21. doi: 10.1016/s0531-5565(99)00068-6.
- Background: PubMed 27668667Qin XY, Zhang SP, Cao C, Loh YP, Cheng Y. Aberrations in Peripheral Inflammatory Cytokine Levels in Parkinson Disease: A Systematic Review and Meta-analysis. JAMA Neurol. 2016 Nov 1;73(11):1316-1324. doi: 10.1001/jamaneurol.2016.2742.
- Background: PubMed 18582534Brodacki B, Staszewski J, Toczylowska B, Kozlowska E, Drela N, Chalimoniuk M, Stepien A. Serum interleukin (IL-2, IL-10, IL-6, IL-4), TNFalpha, and INFgamma concentrations are elevated in patients with atypical and idiopathic parkinsonism. Neurosci Lett. 2008 Aug 22;441(2):158-62. doi: 10.1016/j.neulet.2008.06.040. Epub 2008 Jun 19.
- Background: PubMed 35246670Tansey MG, Wallings RL, Houser MC, Herrick MK, Keating CE, Joers V. Inflammation and immune dysfunction in Parkinson disease. Nat Rev Immunol. 2022 Nov;22(11):657-673. doi: 10.1038/s41577-022-00684-6. Epub 2022 Mar 4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia M Nowak, MD (+48223265427, julia.nowak@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual motor progression rate - Unified Parkinson's Disease Rating Scale PART III OFF (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06834191, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.