Clinical trial NCT06107426: Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease
Official title: A Global Real-World Evidence Study on the Long-term Effectiveness of ABBV-951 in Advanced Parkinson´s Disease in Routine Clinical Practice (ROSSINI: Real-world Outcomes With continuouS Subcutaneous Levodopa INfusIon)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's Disease
Advance Parkinson's Disease
ABBV-951
Foslevodopa/foscarbidopa
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-10-30
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with Advanced PD, treated with ABBV-951 according to label and local reimbursement regulations, where applicable.

Brief summary: 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.


Eligibility criteria: 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:

  * Cohort A: Naïve to ABBV-951
  * Cohort B: Pre-treated with ABBV-951, specifically, participants of Open-Label Extension Studies M15-737 and M20-098 who completed these studies without significant protocol deviations and who did not experience an adverse event (AE) that in the investigator's opinion may indicate an unacceptable safety risk.
* 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.

  * If the participant has a score of 19-23, he/she can be included if based on the investigator´s judgment the participant is able to handle the therapy and follow the study procedures with the help of a permanent caregiver.
* 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.

Primary outcomes:
measure: Change From Baseline in OFF Time (hours)
timeFrame: Up to approximately 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Banner Sun Health Research Institute /ID# 253461
state: Arizona
city: Palo Alto
country: United States
facility: Parkinson's Disease and Movement Disorders Center /ID# 264703
state: California
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 253465
state: Florida
city: Orlando
country: United States
facility: N1 Research, LLC /ID# 264221
state: Florida
city: Tampa
country: United States
facility: University of South Florida- Neuroscience Institute /ID# 253470
state: Florida
city: Chicago
country: United States
facility: Northwestern /ID# 266977
state: Illinois
city: Kansas City
country: United States
facility: Kansas City VA Medical Center /ID# 253466
state: Missouri
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo Cent /ID# 259390
state: Nevada
city: Commack
country: United States
facility: David L. Kreitzman, MD, PC /ID# 259397
state: New York
city: Charlotte
country: United States
facility: Novant Health Neurology and Sleep /ID# 259391
state: North Carolina
city: Canton
country: United States
facility: NeuroCare Center /ID# 259392
state: Ohio
city: Tulsa
country: United States
facility: The Movement Disorder Clinic of Oklahoma /ID# 253463
state: Oklahoma
city: Georgetown
country: United States
facility: Texas Movement Disorder Specialists /ID# 253473
state: Texas
city: San Antonio
country: United States
facility: Univ Texas HSC San Antonio /ID# 259394
state: Texas
city: Spokane
country: United States
facility: Inland Northwest Research /ID# 253460
state: Washington
city: Linz
country: Austria
facility: Kepler Universitaetsklinikum GmbH /ID# 262776
state: Oberoesterreich
city: Graz
country: Austria
facility: Medizinische Universitaet Graz /ID# 262774
state: Steiermark
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck /ID# 262775
state: Tirol
city: Vienna
country: Austria
facility: Klinik Ottakring /ID# 262773
state: Wien
city: Calgary
country: Canada
facility: University of Calgary /ID# 262833
state: Alberta
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus /ID# 263315
state: Ontario
city: Montreal
country: Canada
facility: CHUM - Centre hospitalier de l'Universite de Montréal /ID# 269689
state: Quebec
city: Quebec City
country: Canada
facility: Centre de Recherche St-Louis /ID# 262746
state: Quebec
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital /ID# 252032
state: Hovedstaden
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup /ID# 252035
state: Hovedstaden
city: Odense
country: Denmark
facility: Odense University Hospital /ID# 252036
state: Syddanmark
city: Wolfach
country: Germany
facility: Parkinson-Klinik Ortenau GmbH&Co KG /ID# 252376
state: Baden-Wuerttemberg
city: Muenchen
country: Germany
facility: LMU Klinikum Campus Grosshadern /ID# 255574
state: Bayern
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann /ID# 252375
state: Brandenburg
city: Osnabrueck
country: Germany
facility: Klinikum Osnabrueck GmbH /ID# 252275
state: Niedersachsen
city: Halle (Saale)
country: Germany
facility: Krankenhaus Martha-Maria Halle-Doelau /ID# 260372
state: Sachsen-Anhalt
city: Beelitz-Heilstaetten
country: Germany
facility: Kliniken Beelitz GmbH /ID# 252665
city: Bottrop
country: Germany
facility: Knappschaftskrankenhaus Bottrop /ID# 252274
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 260421
state: H_efa
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 254823
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 254824
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 257715
state: Yerushalayim
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 257717
city: Petah Tikva
country: Israel
facility: Rabin Medical Center /ID# 257716
city: Timisoara
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252248
state: Timis
city: Timisoara
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Timisoara /Id# 252249
state: Timis
city: Brasov
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Brasov /ID# 253308
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina /ID# 252250
city: Constanta
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Constanta /ID# 252251
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 252247
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 261402
state: A Coruna
city: Elche
country: Spain
facility: Hospital General Universitario de Elche /ID# 254438
state: Alicante
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda /ID# 260921
state: Madrid
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves /ID# 257588
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos /ID# 260922
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 254437
city: Stockholm
country: Sweden
facility: Centrum for neurologi /ID# 252118
state: Stockholms Lan
city: Uppsala
country: Sweden
facility: Uppsala University Hospital /ID# 252119
state: Uppsala Lan
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset /ID# 252115
state: Vastra Gotalands Lan
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: