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Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to evaluate how effective ABBV-951 is in treating adult participants with advanced PD in real world setting.
ABBV-951 (foslevodopa/foscarbidopa) is an approved drug for the treatment of Parkinson's Disease. The main ROSSINI study will have approximately 450 adult participants with PD (300 participants new to ABBV-951, up to 150 participants transitioning from open-label extension study) will be enrolled across approximately 60 sites. Decision to treat with ABBV-951 (or continue the treatment in Cohort B) will be made by the doctor prior to any decision to approach the participant to participate in this study. There will be a sub-study that will enroll 40 naïve participants who initiated Foslevodopa/Foscarbidopa treatment for the first time (Cohort A of the ROSSINI parent study only) from 6 to 15 centers in the United States, Germany and Spain.
All participants will receive subcutaneous infusion of ABBV-951 for approximately 3 years.
Participants will attend regular clinic visits during the course of the study. The effect of the treatment will be checked by medical assessments, and completing questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: ABBV-951 | Participants naïve to ABBV-951 will receive ABBV-951 as prescribed by their physician according to the local label. | ||
| Cohort B: ABBV-951 | Participants transitioning from the Open-Label Extension studies M15-737 and M20-098 will continue to receive ABBV-951. | ||
| Country Specific Sub-Study | Participants located in the United States, Germany and Spain, that participated in Cohort A, will participate in a single initial interview and those who continue on the treatment after 6 months will participate in a follow-up interview to explore the longitudinal impact of the treatment. Those participants who discontinue prior to the 6 months time point will engage in a discontinuation interview to understand reasons for their discontinuation of treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in OFF Time (hours) | The mean change from baseline to each scheduled visit in the number of hours spent in OFF time will be estimated using a mixed-effect model repeated-measures (MMRM). | Up to approximately 3 years |
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Inclusion Criteria:
Eligibility for ABBV-951 therapy in accordance with the approved local label in the participating country and local reimbursement regulations, if applicable.
Diagnosis of levodopa-responsive idiopathic Parkinson's Disease (PD).
Participant must be either:
Decision to treat with ABBV-951 (or continue the treatment in Cohort B) made by the clinician 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 participant has had the opportunity to have questions answered.
Exclusion Criteria:
Any condition included in the contraindications section of the approved local ABBV-951 label in the participating country.
Mini-Mental State Examination (MMSE) score < 24.
Participation in a concurrent interventional clinical trial from enrollment and throughout the study.
History of significant skin conditions or disorders per investigator´s judgment. In case of temporary affections like recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations, the participant should not be included if the investigator considers these as interfering with the infusion of study drug or with study assessments.
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Participants with Advanced PD, treated with ABBV-951 according to label and local reimbursement regulations, where applicable.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham - Main /ID# 253477 | Birmingham | Alabama | 35233 | United States | ||
| Banner Sun Health Research Institute /ID# 253461 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42098450 | Derived | Jost WH, Bergquist F, Evans A, Hassin-Baer S, Hauser RA, Henriksen T, Malaty IA, Mestre TA, Mir P, Rodriguez R, Schwingenschuh P, Simu M, Bergmann L, Zhou TT, Caughlin S, Gopalkrishnan M, Kukreja P, O'Meara M, Parra JC, Shah MB, Aldred J. Real-World Safety and Effectiveness of 24-Hour Foslevodopa/Foscarbidopa in Parkinson's Disease: ROSSINI Study 6-Month Interim Results. Neurol Ther. 2026 May 7. doi: 10.1007/s40120-026-00948-6. Online ahead of print. |
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| Sun City |
| Arizona |
| 85351 |
| United States |
| Parkinson's Research Centers of America - Palo Alto /ID# 264703 | Palo Alto | California | 94301-2011 | United States |
| Georgetown University Hospital /ID# 259381 | Washington D.C. | District of Columbia | 20007 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 253465 | Boca Raton | Florida | 33486 | United States |
| University of Florida College of Medicine /ID# 259383 | Gainesville | Florida | 32610 | United States |
| University of Miami /ID# 259396 | Miami | Florida | 33138 | United States |
| N1 Research, LLC /ID# 264221 | Orlando | Florida | 32825-3769 | United States |
| University of South Florida- Neuroscience Institute /ID# 253470 | Tampa | Florida | 33613 | United States |
| Northwestern Medicine Primary And Specialty Care Lavin Family Pavilion /ID# 266977 | Chicago | Illinois | 60611 | United States |
| Ochsner Medical Center - Jefferson Highway /ID# 269764 | New Orleans | Louisiana | 70121 | United States |
| Boston Medical Center Health System /ID# 269765 | Brighton | Massachusetts | 02135 | United States |
| University of Minnesota - Minneapolis /ID# 268121 | Minneapolis | Minnesota | 55455-0341 | United States |
| Kansas City VA Medical Center /ID# 253466 | Kansas City | Missouri | 64128 | United States |
| Cleveland Clinic Lou Ruvo Cent /ID# 259390 | Las Vegas | Nevada | 89106-0100 | United States |
| David L. Kreitzman, MD, PC /ID# 259397 | Commack | New York | 11725-6021 | United States |
| Northwell Health /ID# 253469 | Lake Success | New York | 11042 | United States |
| Novant Health Neurology and Sleep /ID# 259391 | Charlotte | North Carolina | 28207-1100 | United States |
| Atrium Health Wake Forest Baptist Medical Center /ID# 259387 | Winston-Salem | North Carolina | 27157 | United States |
| NeuroCare Center /ID# 259392 | Canton | Ohio | 44718-2531 | United States |
| The Movement Disorder Clinic of Oklahoma /ID# 253463 | Tulsa | Oklahoma | 74136-6378 | United States |
| Vanderbilt University Medical Center /ID# 253474 | Nashville | Tennessee | 37232-0011 | United States |
| Texas Movement Disorder Specialists /ID# 253473 | Georgetown | Texas | 78628-4126 | United States |
| Univ Texas HSC San Antonio /ID# 259394 | San Antonio | Texas | 78229-3901 | United States |
| University of Utah /ID# 253471 | Salt Lake City | Utah | 84112-5500 | United States |
| Evergreenhealth Medical Center /ID# 268120 | Kirkland | Washington | 98034 | United States |
| Inland Northwest Research /ID# 253460 | Spokane | Washington | 99202-1342 | United States |
| Westmead Hospital /ID# 259670 | Westmead | New South Wales | 2145 | Australia |
| The Royal Melbourne Hospital /ID# 259671 | Parkville | Victoria | 3050 | Australia |
| Klinik Ottakring /ID# 262773 | Vienna | State of Vienna | 1160 | Austria |
| Medizinische Universitaet Graz /ID# 262774 | Graz | Styria | 8010 | Austria |
| Medizinische Universitaet Innsbruck /ID# 262775 | Innsbruck | Tyrol | 6020 | Austria |
| Kepler Universitaetsklinikum GmbH /ID# 262776 | Linz | Upper Austria | 4020 | Austria |
| University of Calgary /ID# 262833 | Calgary | Alberta | T2N 4Z6 | Canada |
| The Ottawa Hospital - General Campus /ID# 263315 | Ottawa | Ontario | K1H 8L6 | Canada |
| CHUM - Centre hospitalier de l'Universite de Montréal /ID# 269689 | Montreal | Quebec | H2X 0A9 | Canada |
| Centre de Recherche St-Louis /ID# 262746 | Québec | Quebec | G1W 4R4 | Canada |
| Bispebjerg Hospital /ID# 252032 | Copenhagen | Capital Region | 2400 | Denmark |
| Rigshospitalet Glostrup /ID# 252035 | Glostrup Municipality | Capital Region | 2600 | Denmark |
| Odense University Hospital /ID# 252036 | Odense | Region Syddanmark | 5000 | Denmark |
| Parkinson-Klinik Ortenau GmbH&Co KG /ID# 252376 | Wolfach | Baden-Wurttemberg | 77709 | Germany |
| Klinikum der Universitaet Muenchen Grosshadern /ID# 255574 | Munich | Bavaria | 81337 | Germany |
| Klinikum Ernst von Bergmann /ID# 252375 | Potsdam | Brandenburg | 14467 | Germany |
| Klinikum Osnabrueck GmbH /ID# 252275 | Osnabrück | Lower Saxony | 49076 | Germany |
| Krankenhaus Martha-Maria Halle-Doelau /ID# 260372 | Halle | Saxony-Anhalt | 06120 | Germany |
| Kliniken Beelitz GmbH /ID# 252665 | Beelitz-Heilstätten | 14547 | Germany |
| Knappschaftskrankenhaus Bottrop /ID# 252274 | Bottrop | 46242 | Germany |
| Shaare Zedek Medical Center /ID# 257715 | Jerusalem | Jerusalem | 91031 | Israel |
| The Chaim Sheba Medical Center /ID# 254823 | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Tel Aviv Sourasky Medical Center /ID# 254824 | Tel Aviv | Tel Aviv | 6423906 | Israel |
| Rambam Health Care Campus- Haifa /ID# 260421 | Haifa | 3525408 | Israel |
| Hadassah Medical Center-Hebrew University /ID# 257717 | Jerusalem | 91120 | Israel |
| Rabin Medical Center. /ID# 257716 | Petah Tikva | 4941492 | Israel |
| Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252248 | Timișoara | Timiș County | 300736 | Romania |
| Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252249 | Timișoara | Timiș County | 300736 | Romania |
| Spitalul Clinic Judetean de Urgenta Brasov /ID# 253308 | Brasov | 500326 | Romania |
| Spitalul Clinic Colentina /ID# 252250 | Bucharest | 020121 | Romania |
| Spitalul Clinic Judetean de Urgenta Constanta /ID# 252251 | Constanța | 900591 | Romania |
| Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 252247 | Târgu Mureş | 540136 | Romania |
| Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 261402 | Santiago de Compostela | A Coruna | 15706 | Spain |
| Hospital General Universitario de Elche /ID# 254438 | Elche | Alicante | 03203 | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda /ID# 260921 | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario Virgen de las Nieves /ID# 257588 | Granada | 18014 | Spain |
| Hospital Clinico San Carlos /ID# 260922 | Madrid | 28040 | Spain |
| Hospital Universitario Virgen del Rocio /ID# 254437 | Seville | 41013 | Spain |
| Centrum for neurologi /ID# 252118 | Stockholm | Stockholm County | 113 65 | Sweden |
| Uppsala University Hospital /ID# 252119 | Uppsala | Uppsala County | 75185 | Sweden |
| Sahlgrenska Universitetssjukhuset /ID# 252115 | Gothenburg | Västra Götaland County | 413 46 | Sweden |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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