Parkinson´s DiseaseROPADNCT03866603
Rostock International Parkinson's Disease Study (ROPAD)
An observational study of Parkinson´s Disease, run by CENTOGENE GmbH Rostock at 110 sites in 15 countries.
Trial summary
Rostock International Parkinson's Disease Study - An International, multicenter, epidemiological observational study aiming at identification of LRRK2-positive patients, the recruitment of 25,000 PD participants and the establishment of a candidate biomarker in the LRRK2-positive cohort. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson´s Disease
- How many people
- 20,112 participants
- Where
- 110 sitesin 15 countries
- Study dates
- 30 May 2019to 10 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants clinically diagnosed with Parkinson's Disease (PD)
- Informed consent is obtained from the participant
- The participant has been clinically diagnosed with Parkinson's disease within the last 5 years (≤ 5 years)
- The participant is between 30 and 80 years old
Trial locations and contacts
110 sites in 15 countries.
110 sites in 15 countries
United States26 sites
Dent Neurologic Institue
Amherst, New York, 14226
Parkinson's Disease and Movement Disorder Center of Baco Raton
Baco Raton, Florida, 33486
Stony Brook University School of Medicine
Brookhaven, New York, 11772
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421
Rush University Medical Center
Chicago, Illinois, 60612
Linfritz Research Institute
Coral Gables, Florida, 33134
Duke University, Department of Neurology
Durham, North Carolina, 27710
Pharmacology Research Institute
Encino, California, 91316
Northshore University HealthSystem
Evanston, Illinois, 60201
Michigan Institute for Neurological Disorders
Farmington Hills, Michigan, 48334
Neuro-Pain Medical Center
Fresno, California, 93710
Indiana University, Department of Neurology
Indianapolis, Indiana, 46202
Booth Gardner Parkinson's Care Center
Kirkland, Washington, 98034
University of California (UC) San Diego
La Jolla, California, 92093
WR-CRCN
Las Vegas, Nevada, 89106
Loma Linda University
Loma Linda, California, 92354
Pharmacology Research Institute
Los Alamitos, California, 90720
Pharmacology Research Institute
Newport Beach, California, 92660
Renstar Medical Research
Ocala, Florida, 34475
South Shore Neurologic Associates
Patchogue, New York, 11772
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612
Inland Northwest Research
Spokane, Washington, 99202
University of South Florida
Tampa, Florida, 33613
Neuroscience Research Institute of NJ
Toms River, New Jersey, 08755
Tucson Neuroscience Research
Tucson, Arizona, 85710
Vero Beach Neurology & Research Institute
Vero Beach, Florida, 32960
Germany18 sites
Universitätsklinik für Neurologie
Aachen, 52074
Neurologisches Fachkrankenhaus für Bewegungsstörungen / Parkinson
Beelitz, 14547
Kliniken Beelitz
Beelitz-Heilstätten, 14547
Charite University Medicine
Berlin, 10117
Gertrudis-Kliniken im Parkison-Zentrum
Biskirchen, 35638
St. Josef-Hospital
Bochum, 44791
Universitätsklinikum Carl Gustav Carus die Dresdner
Dresden, 01307
Asklepios Klinik Barmbek
Hamburg, 22291
Universitätsklinik Hamburg-Eppendorf
Hamburg-Eppendorf, 20246
Universitätsklinik für Neurologie
Jena, 7740
Paracelsus Elena-Klinik
Kassel, 34128
Universitätsklinikum Schleswig-Holstein, Klinik für Neurologie
Kiel, 24105
Universitätsklinikum Leipzig
Leipzig, 04103
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, 23538
Universitätsklinikum Marburg Klinik und Poliklinik für Neurologie Parkinson Netzwerk Allianz Marburg (PANAMA)
Marburg, 35043
Diakonie-Klinikum Schwäbisch Hall gGmbH
Schwäbisch Hall, 74523
Asklepios Fachklinikum Stadtroda Klinik für Neurologie, Schmerztherapie und Schlafmedizin
Stadtroda, 07646
Universitätsklinikum Würzburg
Würzburg, 97080
Brazil13 sites
Hospital Ophir Loyola
Belém, Pará, PA-66063-240
Hospital das Clínicas da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100
Hospital Universitário Walter Cândido/ Universidade Federal do Ceará
Ceará, 60430-372
Hospital Angelina Caron
Curitiba, 83430-000
Fundação Hospital Adriano Jorge
Manaus, 1778
Federal University of Health Science of Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-190
Carolina São Souza
Ribeirão Preto, 14015-130
Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, 14040-900
Hospital Universitario Pedro Ernesto (HUPE)
Rio de Janeiro, 20550-000
Universidade Metropolitana De Santos
Santos, São Paulo, CEP 11.045-002
Universidade Federal de São Paulo, UNIFESP
São Paulo, 04040-003
Clinica de Neurocirurgia E Neurofisiologia Ltda
São Paulo, 1636
Instituto Israelita de Ensino e Pesquisa Albert Einstein
São Paulo, 69065-001
Spain12 sites
Hospital Universitario Fundación Alcorcón
Alcorcón, 28922
Instituto Investigacion Biocruces
Barakaldo, 48903
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario de La Princesa
Madrid, Madrid, 28006
Hospital Clínico San Carlos
Madrid, Madrid, 28049
Hospital General Unversitario Gregorio Marañón
Madrid, 28007
HM CINAC | Integrated Neuroscience Center
Móstoles, 28938
Clinica Universidad de Navarra (CUN)
Pamplona, 31008
Hospital Universitario Donostia
San Sebastián, 20014
University Hospital Marqués de Valdecilla
Santander, 39008
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, Corunna, 15706
United Kingdom12 sites
Fairfield General Hospital
Bury, BL9 7TD
University of Dundee
Dundee, DD1 5EH
University of Edinburgh
Edinburgh, EH16 4SB
Royal Devon and Exeter Hospital
Exeter, EX2 5DW
Imperial College Healthcare NHS Trust
London, W6 8RF
Newcastle University, Clinical Ageing Research Unit
Newcastle upon Tyne, NE4 5PL
University of Oxford, Nuffield Department of Clinical Neurosciences
Oxford, OX3 9DU
University of Plymouth
Plymouth, PL6 8BX
Royal Preston Hospital, Department of Neurology
Preston, PR2 9HT
Salford Royal NHS Foundation Trust
Salford, M6 8HD
Royal Cornwall Hospitals Nhs Trust
Truro, TR1 3LQ
Yeovil District Hospital
Yeovil, BA21 4AT
Israel10 sites
Samson Assuta Ashdod University Hospital
Ashdod, 7747629
Barzilai Medical Center
Ashkelon, 7830604
Shamir Medical Center
Be’er Ya‘aqov
Soroka Medical Center
Beersheba, 8457108
RAMBAM Medical Center
Haifa, 3109601
Shaare Zedek Medical Center
Jerusalem, 9103102
Hadassah Medical Center
Jerusalem, 91120
Rabin MC, Beilinson Campus
Petah Tikva, 4941492
Sheba Medical Center
Ramat Gan, 52621
Tel Aviv Sourasky Medical Center - TASMC
Tel Aviv, 64239
Belgium4 sites
University Hospital of Antwerp
Antwerp, 2650
UZ Leuven, Campus Gasthuisberg
Leuven, 3000
Department of Neurology, Centre Hospitalier Universitaire (CHU) de Leige
Liège, 4000
AZ Damiaan, Department of Neurology
Ostend, 1008400
Italy4 sites
AOUP Secondo Policlinico Federico II Napoli
Naples, 80131
Università di Pavia, Dipartimento di Medicina Molecolare
Pavia, 27100
Asmn - Irccs
Reggio Emilia, 42123
I.R.C.C.S. San Raffaele Pisana
Roma, 00163
Turkey (Türkiye)4 sites
Istanbul Faculty of Medicine
Istanbul, Istanbul, 34093
Koc University Hospital
Istanbul, 34010
Mersin Faculty of Medicine
Mersin, Mersin, 33110
Cukurova University Faculty of Medicine
Sarıçam, Adana, 01790
Portugal2 sites
Neurology Department, Hospital de Santa Maria
Lisbon, 1649-035
Centro Hospitalar Universitário de São João
Porto, 4200-319
Canada1 site
Toronto Western Hospital, University Health Network, University of Toronto
Toronto, Ontario, M5T 2S8
About this study
Official title: Rostock International Parkinson's Disease Study: an International, Multicenter, Epidemiological Observational Study
Rostock International Parkinson's Disease Study - An International, multicenter, epidemiological observational study aiming at identification of LRRK2-positive patients, the recruitment of 25,000 PD participants and the establishment of a candidate biomarker in the LRRK2-positive cohort.
Read the detailed description
Parkinson's disease (PD) is one of the most common neurodegenerative disorders worldwide, affecting approximately 1% of individuals older than 60 years and causes progressive disability.
Clinical signs and symptoms of PD include the following: asymmetric tremor at rest, bradykinesia, muscle rigidity, postural instability, gait abnormalities including festination and freezing. Onset is typically after the age of 50 years and the disease is commonly slowly progressive. The most common initial finding of PD is a resting tremor in the upper extremity. Over time, participants experience progressive bradykinesia, rigidity, and gait difficulty, while the axial posture becomes progressively flexed. Non-motor symptoms are common in all stages of Parkinson disease and they include constipation, seborrhea, hyposmia or anosmia, sympathetic denervation of the heart, depression and/or apathy, sleep disturbances, cognitive decline and dementia. They may appear prior to the movement disorder and can be used as preclinical markers of PD.
PD is mostly considered as idiopathic disease; however more and more data suggest that it is a disease that involves interaction of genetic and environmental factors. The most common monogenic form and the one most closely resembling idiopathic PD is LRRK2 (Leucine-rich repeat kinase 2 gene) associated PD.
The most common monogenic form and the one most closely resembling idiopathic PD is LRRK2 (Leucine-rich repeat kinase 2 gene) associated PD. First identified in 2004, LRRK2 mutations are currently still the most commonly known cause of PD and account for up to ~40% of all Parkinson's disease cases in select populations. The majority of reported LRRK2-positive PD patients are Caucasian (63%), whereas all other ethnicities comprise ~10% or fewer patients of described mutation carriers despite clusters in the Ashkenazi Jewish and Arab Berber populations. With respect to country of origin, the majority of patients were re-ported to reside in Italy or Spain (14% each), Great Britain (10%) or Norway (9%). Definitely pathogenic variants identified in LRRK2 include p.G2019S, p.R1441C/G/H, p.N1437H, p.Y1699C, and, p.I2020T. Of these, the p.R1441G mutation is particularly frequent, as it represents a founder mutation in the Basque population where it is responsible for 46% of all familial PD. Very rarely, this mutation has also been observed in other populations where it arose on a different haplotype. LRRK2 p.Gly2019Ser mutation accounts for about 0.5% simplex cases and >5% familial cases in various ethnic groups worldwide. Furthermore, genome-wide association studies have identified common polymorphisms in LRRK2 that associate with idiopathic PD, implicating LRRK2 function in susceptibility to late-onset PD in individuals without pathogenic mutations.
LRRK2 mutations cause PD with age-related penetrance and clinical features identical to late-onset sporadic PD. Biochemical studies support an increase in LRRK2 kinase activity and a decrease in GTPase activity for kinase domain and Roc-COR mutations, respectively. Strong evidence exists that LRRK2 toxicity is kinase dependent, leading to extensive efforts to identify selective and brain-permeable LRRK2 kinase inhibitors for clinical development. LRRK2 kinase inhibition is currently one of the most prevailing disease-modifying therapeutic strategies for PD. Thus, LRRK2 kinase inhibitors are in development as potential Parkinson's disease therapeutics.
Furthermore, there is now evidence showing that LRRK2 expression and phosphorylation levels have a potential as markers of Parkinson's disease. Recently, the presence of Lrrk2 was confirmed in exosomes from human biofluids, including urine and cerebrospinal fluid. Moreover, elevated LRRK2 autophosphorylation was identified in brain-derived and peripheral exosomes in LRRK2-mutation carriers. In summary, it has been shown that markers of LRRK2 activity and function may be detected in human blood and that they are relevant for pathogenesis if PD.
Thus, the biochemical analyses of human blood from LRRK2 positive participants and LRRK2 negative participants create a strong base for the development of PD-related biomarkers. This biomarker may in turn be even more accessible than genetic testing and it may serve for diagnosis, prognosis, and prediction of PD.
- Conditions
- Parkinson´s Disease
- Keywords
- Parkinson´s disease, Biomarker, LRRK2, GBA, PD Genetics
- 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 |
|---|---|---|
| Parkinson´s disease individuals | * The participant has been clinically diagnosed with Parkinson's disease within the last 5 years (≤ 5 years) * The participant is between 30 and 80 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the prevalence of genetic etiologies of PD
Measured: 79 months
Secondary outcomes (1)
To identify LRRK2-positive PD participants from the primary strata, Establishment of a biomarker in the LRRK2-positive cohort
Measured: 79 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start30 May 2019
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson´s DiseaseStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 20,112 participants (actual)
Sponsor and investigators
- Lead sponsor
- CENTOGENE GmbH Rostock
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Bauer, MD, Principal investigator, CENTOGENE GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866603
- Sponsor's protocol ID
- ROPAD 01-2019
- Acronym
- ROPAD
- Status last verified
- Apr 2026
- First submitted
- 1 Mar 2019
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan will be defined at a later stages
Publications
Baumann CR. Epidemiology, diagnosis and differential diagnosis in Parkinson's disease tremor. Parkinsonism Relat Disord. 2012 Jan;18 Suppl 1:S90-2. doi: 10.1016/S1353-8020(11)70029-3.
PubMed 22166466Dayan R, Bick AS, Weill C, Bauer M, Erdman HB, Israel Z, Bergman H, Levin N, Arkadir D. Atrophy-related corticospinal changes in advanced Parkinson's disease are associated with the genetic etiology of the disease. J Parkinsons Dis. 2024 Nov;14(8):1584-1593. doi: 10.3233/JPD-240267. Epub 2024 Nov 4.
PubMed 39957202
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rostock International Parkinson's Disease Study: an International, Multicenter, Epidemiological Observational Study
- ClinicalTrials.gov ID
- NCT03866603
- Acronym / sponsor ID
- ROPAD / ROPAD 01-2019
- Conditions
- Parkinson´s Disease
- Keywords
- Parkinson´s disease, Biomarker, LRRK2, GBA, PD Genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20,112 participants (actual)
- Lead sponsor
- CENTOGENE GmbH RostockIndustry (pharma, biotech, devices)
- Study start
- 30 May 2019 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 7 Mar 2019 (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.
Rostock International Parkinson's Disease Study - An International, multicenter, epidemiological observational study aiming at identification of LRRK2-positive patients, the recruitment of 25,000 PD participants and the establishment of a candidate biomarker in the LRRK2-positive cohort.
Detailed description
Parkinson's disease (PD) is one of the most common neurodegenerative disorders worldwide, affecting approximately 1% of individuals older than 60 years and causes progressive disability.
Clinical signs and symptoms of PD include the following: asymmetric tremor at rest, bradykinesia, muscle rigidity, postural instability, gait abnormalities including festination and freezing. Onset is typically after the age of 50 years and the disease is commonly slowly progressive. The most common initial finding of PD is a resting tremor in the upper extremity. Over time, participants experience progressive bradykinesia, rigidity, and gait difficulty, while the axial posture becomes progressively flexed. Non-motor symptoms are common in all stages of Parkinson disease and they include constipation, seborrhea, hyposmia or anosmia, sympathetic denervation of the heart, depression and/or apathy, sleep disturbances, cognitive decline and dementia. They may appear prior to the movement disorder and can be used as preclinical markers of PD.
PD is mostly considered as idiopathic disease; however more and more data suggest that it is a disease that involves interaction of genetic and environmental factors. The most common monogenic form and the one most closely resembling idiopathic PD is LRRK2 (Leucine-rich repeat kinase 2 gene) associated PD.
The most common monogenic form and the one most closely resembling idiopathic PD is LRRK2 (Leucine-rich repeat kinase 2 gene) associated PD. First identified in 2004, LRRK2 mutations are currently still the most commonly known cause of PD and account for up to ~40% of all Parkinson's disease cases in select populations. The majority of reported LRRK2-positive PD patients are Caucasian (63%), whereas all other ethnicities comprise ~10% or fewer patients of described mutation carriers despite clusters in the Ashkenazi Jewish and Arab Berber populations. With respect to country of origin, the majority of patients were re-ported to reside in Italy or Spain (14% each), Great Britain (10%) or Norway (9%). Definitely pathogenic variants identified in LRRK2 include p.G2019S, p.R1441C/G/H, p.N1437H, p.Y1699C, and, p.I2020T. Of these, the p.R1441G mutation is particularly frequent, as it represents a founder mutation in the Basque population where it is responsible for 46% of all familial PD. Very rarely, this mutation has also been observed in other populations where it arose on a different haplotype. LRRK2 p.Gly2019Ser mutation accounts for about 0.5% simplex cases and >5% familial cases in various ethnic groups worldwide. Furthermore, genome-wide association studies have identified common polymorphisms in LRRK2 that associate with idiopathic PD, implicating LRRK2 function in susceptibility to late-onset PD in individuals without pathogenic mutations.
LRRK2 mutations cause PD with age-related penetrance and clinical features identical to late-onset sporadic PD. Biochemical studies support an increase in LRRK2 kinase activity and a decrease in GTPase activity for kinase domain and Roc-COR mutations, respectively. Strong evidence exists that LRRK2 toxicity is kinase dependent, leading to extensive efforts to identify selective and brain-permeable LRRK2 kinase inhibitors for clinical development. LRRK2 kinase inhibition is currently one of the most prevailing disease-modifying therapeutic strategies for PD. Thus, LRRK2 kinase inhibitors are in development as potential Parkinson's disease therapeutics.
Furthermore, there is now evidence showing that LRRK2 expression and phosphorylation levels have a potential as markers of Parkinson's disease. Recently, the presence of Lrrk2 was confirmed in exosomes from human biofluids, including urine and cerebrospinal fluid. Moreover, elevated LRRK2 autophosphorylation was identified in brain-derived and peripheral exosomes in LRRK2-mutation carriers. In summary, it has been shown that markers of LRRK2 activity and function may be detected in human blood and that they are relevant for pathogenesis if PD.
Thus, the biochemical analyses of human blood from LRRK2 positive participants and LRRK2 negative participants create a strong base for the development of PD-related biomarkers. This biomarker may in turn be even more accessible than genetic testing and it may serve for diagnosis, prognosis, and prediction of PD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson´s disease individuals | – | –* The participant has been clinically diagnosed with Parkinson's disease within the last 5 years (≤ 5 years) * The participant is between 30 and 80 years old |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants clinically diagnosed with Parkinson's Disease (PD)
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
To investigate the prevalence of genetic etiologies of PD
Time frame: 79 months
1 secondary outcome
To identify LRRK2-positive PD participants from the primary strata, Establishment of a biomarker in the LRRK2-positive cohort
Time frame: 79 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Results publication: PubMed 22166466Baumann CR. Epidemiology, diagnosis and differential diagnosis in Parkinson's disease tremor. Parkinsonism Relat Disord. 2012 Jan;18 Suppl 1:S90-2. doi: 10.1016/S1353-8020(11)70029-3.
- Derived from this study: PubMed 39957202Dayan R, Bick AS, Weill C, Bauer M, Erdman HB, Israel Z, Bergman H, Levin N, Arkadir D. Atrophy-related corticospinal changes in advanced Parkinson's disease are associated with the genetic etiology of the disease. J Parkinsons Dis. 2024 Nov;14(8):1584-1593. doi: 10.3233/JPD-240267. Epub 2024 Nov 4.
- Individual participant dataSharing planned: No. The plan will be defined at a later stages
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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. This study is not recruiting at the moment.
Peter Bauer, MD principal investigator
CENTOGENE GmbH
110 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson´s Disease, run by CENTOGENE GmbH Rostock at 110 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 110 sites in United States, Germany, Brazil, Spain, United Kingdom and 10 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the prevalence of genetic etiologies of PD (time frame: 79 months). 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 NCT03866603, which also lists 2 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 13 Apr 2026.