Observational Study Evaluating Long-Term Effectiveness of Duodopa/Duopa in Patients With Advanced Parkinson's Disease
NCT ID: NCT02611713
Last Updated: 2021-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
213 participants
OBSERVATIONAL
2016-01-04
2020-12-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A: Participants with Advanced Parkinson's Disease
Participants who along with their physicians have elected for treatment with Duodopa/Duopa and are prescribed according to the local product label and reimbursement guidelines for their participating countries.
No interventions assigned to this group
Arm B: Participants with Advanced Parkinson's Disease
Participants who along with their physicians have elected for treatment with Duodopa/Duopa and are prescribed according to the local product label and reimbursement guidelines for their participating countries. Participants will be evaluated with a wearable device
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Duodopa/Duopa naïve participants
* Decision to treat with Duodopa/Duopa made by the physician prior to any decision to approach the participant to participate in this study
* Prior to any study-related procedures being performed, the participant, or legal authorized representative (LAR) has voluntarily signed an Authorization for Use/Disclosure of Data (AUDD)/informed consent form (ICF) according to national regulations after the study has been explained and the subject has had the opportunity to have questions answered.
* For Arm B: Participant and caregiver must be motivated to use the PKG, understand the instructions and be able to handle the device.
* For Arm B: participant must demonstrate at least 75% concordance with the investigator's or qualified designee's assessment of symptoms on the Parkinson's disease diary following training at enrollment visit 1/V1 with concordance on at least 1 time interval of "Off", concordance on at least 1 time interval of "ON regardless of dyskinesia" and at least 1 time interval of "ON with dyskinesia" irrespective of whether the dyskinesia are troublesome or not troublesome.
Exclusion Criteria
* Participants who have had previous surgery for PD including, but not limited to deep brain stimulation (DBS) or cell transplantation (this criterion removed for US sites for Arm A).
* Participants currently in treatment with continuous apomorphine infusion. In case of a previous treatment with continuous subcutaneous apomorphine infusion, there must be at least 4 weeks between discontinuation of this treatment and inclusion into this study.
* Mini-Mental State Examination (MMSE) score \<24
* Participation in a concurrent interventional clinical trial.
* Lack of motivation or insufficient language skills to complete the study questionnaires
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham - Main /ID# 144422
Birmingham, Alabama, United States
Parkinson's Disease and Moveme /ID# 144413
Boca Raton, Florida, United States
University of Florida - Archer /ID# 144415
Gainesville, Florida, United States
University of Miami /ID# 144420
Miami, Florida, United States
Georgia Regents University /ID# 144417
Augusta, Georgia, United States
University of Kansas Health Sy /ID# 154242
Kansas City, Kansas, United States
University of Kentucky Chandler Medical Center /ID# 144421
Lexington, Kentucky, United States
Johns Hopkins University /ID# 144416
Baltimore, Maryland, United States
Mercy St. Mary's Health Center /ID# 144418
Grand Rapids, Michigan, United States
Jared Neuroscience Center /ID# 161629
Springfield, Missouri, United States
Washington University-School of Medicine /ID# 147235
St Louis, Missouri, United States
Univ Nebraska Med Ctr /ID# 147655
Omaha, Nebraska, United States
Wake Forest Univ HS /ID# 144419
Winston-Salem, North Carolina, United States
Penn State Child Hosp.Hersh,PA /ID# 160671
Hershey, Pennsylvania, United States
University of Pennsylvania /ID# 161135
Philadelphia, Pennsylvania, United States
Vanderbilt Univ Med Ctr /ID# 150782
Nashville, Tennessee, United States
University of Vermont Medical Center /ID# 144410
Burlington, Vermont, United States
King County Public Hospital /ID# 144412
Kirkland, Washington, United States
Northwest Neurological, PLLC /ID# 144409
Spokane, Washington, United States
Concord Repatriation & Gen Hos /ID# 144373
Concord, New South Wales, Australia
St. Vincent's Hospital, Darlinghurst /ID# 144376
Darlinghurst, New South Wales, Australia
Kingston Centre /ID# 144374
Cheltenham, Victoria, Australia
Monash Medical Centre /ID# 144375
Clayton, Victoria, Australia
UZ Antwerp /ID# 144378
Edegem, , Belgium
AZ Groeninge /ID# 144377
Kortrijk, , Belgium
CHU Tivoli /ID# 144379
La Louvière, , Belgium
Semmelweis Egyetem /ID# 144381
Budapest, , Hungary
Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 144380
Pécs, , Hungary
Tel Aviv Sourasky Medical Center /ID# 153779
Tel Aviv, Tel Aviv, Israel
Assaf Harofeh Medical Center /ID# 144383
Be’er Ya‘aqov, , Israel
The Edith Wolfson Medical Center /ID# 144382
Holon, , Israel
Sheba Medical Center /ID# 147099
Ramat Gan, , Israel
Ospedale Santo Stefano /ID# 144386
Prato, , Italy
Azienda Ospedaliera Sant' Andrea /ID# 144385
Rome, , Italy
A.O. Circolo e Fondazione Macc /ID# 144384
Varese, , Italy
Institutul Clinic Fundeni /ID# 144448
Sector 2, București, Romania
Spitatlul Clinic Colentina /ID# 144447
Bucharest, , Romania
Spital Universitar Bucuresti /ID# 144446
Bucharesti, , Romania
Spitalul Clinic Judetean de Ur /ID# 144451
Oradea, Judet Bihor, , Romania
Spitalul Clinic Judetean /ID# 144453
Târgu Mureş, , Romania
Sp. Clinic de Judetean /ID# 144449
Timișoara, , Romania
Sp. Clinic de Judetean /ID# 144452
Timișoara, , Romania
Univ Medical Ctr Ljubljana /ID# 144387
Ljubljana, , Slovenia
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 151782
Ferrol, A Coruna, Spain
Hospital Universitario Mutua Terrassa /ID# 144405
Terrassa, Barcelona, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 162277
Pamplona, Navarra, Comunidad, Spain
Hospital de Tortosa Verge de la Cinta /ID# 153502
Tortosa, Tarragona, Spain
OSI Ezkerraldea-Enkarterri-Cruces /ID# 151781
Barakaldo, , Spain
Hospital Universitario Vall d'Hebron /ID# 151778
Barcelona, , Spain
Hospital Universitario de Burgos /ID# 144406
Burgos, , Spain
King's College Hospital NHS /ID# 147130
London, , United Kingdom
St. George's Healthcare NHS /ID# 147131
London, , United Kingdom
Queens Hospital /ID# 147133
Romford, , United Kingdom
Salford Royal NHS Found Trust /ID# 151783
Salford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Chaudhuri KR, Kovacs N, Pontieri FE, Aldred J, Bourgeois P, Davis TL, Cubo E, Anca-Herschkovitsch M, Iansek R, Siddiqui MS, Simu M, Bergmann L, Ballina M, Kukreja P, Ladhani O, Jia J, Standaert DG. Levodopa Carbidopa Intestinal Gel in Advanced Parkinson's Disease: DUOGLOBE Final 3-Year Results. J Parkinsons Dis. 2023;13(5):769-783. doi: 10.3233/JPD-225105.
Aldred J, Anca-Herschkovitsch M, Antonini A, Bajenaru O, Bergmann L, Bourgeois P, Cubo E, Davis TL, Iansek R, Kovacs N, Kukreja P, Onuk K, Pontieri FE, Robieson W, Siddiqui MS, Simu M, Standaert DG, Chaudhuri KR. Application of the '5-2-1' screening criteria in advanced Parkinson's disease: interim analysis of DUOGLOBE. Neurodegener Dis Manag. 2020 Oct;10(5):309-323. doi: 10.2217/nmt-2020-0021. Epub 2020 Sep 2.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P14-494
Identifier Type: -
Identifier Source: org_study_id