Study of foslevodopa/foscarbidopa in adults with advanced Parkinson disease in Italy
Looks at how foslevodopa/foscarbidopa works in adults with advanced Parkinson disease.
Plain-language title generated from the registry record
Registry title: Real-World Study of Foslevodopa/Foscarbidopa to Assess Quality of Life Outcomes in Adult Participants With Advanced Parkinson Disease
Key facts
- Where
- Ancona, Bologna, Messina, Milan, Naples, Padova, Palermo, Pavia, Pisa, Pozzilli, Reggio Emilia, Rome, Salerno, Troina, Turin, and Venice, ItalySee the 19 sites
Where in Italy
- Azienda Ospedaliero Universitaria delle Marche /ID# 272694Ancona, ItalyTaking people
- Ospedale Bellaria - Azienda Usl Di Bologna /ID# 274463Bologna, ItalyTaking people
- IRCCS Centro Neurolesi Bonino Pulejo /ID# 273628Messina, ItalyTaking people
- ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 272949Milan, ItalyTaking people
- Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 273225Milan, ItalyTaking people
- Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273434Naples, ItalyTaking people
- Azienda Ospedale-Universita Padova /ID# 274317Padova, ItalyTaking people
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 272863Palermo, ItalyTaking people
- Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 274226Pavia, ItalyTaking people
- Azienda Ospedaliero Universitaria Pisana /ID# 273541Pisa, ItalyTaking people
- Istituto Neurologico Mediterraneo Neuromed S.P.A. - Irccs /Id# 272695Pozzilli, ItalyTaking people
- AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 274388Reggio Emilia, ItalyTaking people
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 272834Rome, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 273562Rome, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274539Rome, ItalyTaking people
- AOU San Giovanni di Dio Ruggi d'Aragona - Scuola Medica Salernitana /ID# 274319Salerno, ItalyTaking people
- IRCCS Oasi SS. Troina /ID# 273507Troina, ItalyTaking people
- A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 273276Turin, ItalyTaking people
- Azienda Ulss 3 Serenissima /ID# 273027Venice, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AbbVie
- Trial code
- NCT06965374
- Record updated
- 13 May 2026
- Original description
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. This study will assess how effective Foslevodopa/Foscarbidopa is in treating Italian adult participants with advanced Parkinson disease under routine clinical practice. This study will also assess the caregiver quality of life (QOL) (if caregiver is present).Read full original descriptionShow less
Foslevodopa/Foscarbidopa REal-world Evidence in Parkinson's Disease Quality of LIFE Outcomes
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. This study will assess how effective Foslevodopa/Foscarbidopa is in treating Italian adult participants with advanced Parkinson disease under routine clinical practice. This study will also assess the caregiver quality of life (QOL) (if caregiver is present).
Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 270 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 19 sites in Italy.
Participants will receive Foslevodopa/Foscarbidopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 12 months.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
Inclusion: Participants with a diagnosis of levodopa-responsive advance Parkinson's disease (PD); Investigator decision on participant treatment with subcutaneous Foslevodopa/Foscarbidopa (LDp/CDp) made prior to, and independently, the decision to approach the participant to participate in the study; 24-h subcutaneous LDp/CDp treatment prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies.
Exclusion: Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days. Participation in another Post-Marketing Observational Study (PMOS) or Registry is acceptable; Any condition included in the contraindications section of the approved local subcutaneous LDp/CDp label; History of relevant skin conditions or disorders (e.g., psoriasis, atopic dermatitis) per investigator´s judgment. In case of temporary affections like recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations, the subject should not be included if the investigator considers these as interfering with the infusion of study drug or with study assessments.