Study of foslevodopa/foscarbidopa in adults with advanced Parkinson disease in Italy
Looks at how foslevodopa/foscarbidopa works in adults with advanced Parkinson disease.
Key facts
- Who runs it
- AbbVie
- Where
- Ancona, Bologna, Messina, Milan, Naples, Padova, Palermo, Pavia, Pisa, Pozzilli, Reggio Emilia, Rome, Salerno, Troina, Turin, and Venice, ItalySee the 19 sites
- Trial code
- Registry title
- Real-World Study of Foslevodopa/Foscarbidopa to Assess Quality of Life Outcomes in Adult Participants With Advanced Parkinson Disease
- Status
- Recruiting
- People taking part
- 270 people, planned
- Started
- 4 Jun 2025
- Expected to end
- Jun 2027
- Type of study
- Observational
- Record updated
- 13 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults in Italy with advanced Parkinson's disease who have been prescribed Foslevodopa/Foscarbidopa by their doctor as part of routine care.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Advanced Parkinson's disease that responds to levodopa
- Earlier treatment
- Doctor has decided on subcutaneous Foslevodopa/Foscarbidopa treatment before and independently of asking the person to join; 24-hour treatment prescribed according to the approved label and local rules
Main reasons for not taking part
- Any condition listed as a contraindication in the approved local label of the drug
- Taking part in a trial of an investigational drug now or within the last 30 days
- Relevant skin conditions or disorders, such as psoriasis or atopic dermatitis, in the investigator's judgment
- Temporary skin problems, such as sunburn, acne, scars, a tattoo or an open wound, if the investigator thinks they interfere with the infusion or study assessments
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Italy
- Azienda Ospedaliero Universitaria delle Marche /ID# 272694Ancona, ItalyContact: Caterina GolottaTaking people
- Ospedale Bellaria - Azienda Usl Di Bologna /ID# 274463Bologna, ItalyContact: Caterina GolottaTaking people
- IRCCS Centro Neurolesi Bonino Pulejo /ID# 273628Messina, ItalyContact: Caterina GolottaTaking people
- ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 272949Milan, ItalyContact: Caterina GolottaTaking people
- Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 273225Milan, ItalyContact: Caterina GolottaTaking people
- Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273434Naples, ItalyContact: Caterina GolottaTaking people
- Azienda Ospedale-Universita Padova /ID# 274317Padova, ItalyContact: Caterina GolottaTaking people
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 272863Palermo, ItalyContact: Caterina GolottaTaking people
- Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 274226Pavia, ItalyContact: Caterina GolottaTaking people
- Azienda Ospedaliero Universitaria Pisana /ID# 273541Pisa, ItalyContact: Caterina GolottaTaking people
- Istituto Neurologico Mediterraneo Neuromed S.P.A. - Irccs /Id# 272695Pozzilli, ItalyContact: Caterina GolottaTaking people
- AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 274388Reggio Emilia, ItalyContact: Caterina GolottaTaking people
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 272834Rome, ItalyContact: Caterina GolottaTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 273562Rome, ItalyContact: Caterina GolottaTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274539Rome, ItalyContact: Caterina GolottaTaking people
- AOU San Giovanni di Dio Ruggi d'Aragona - Scuola Medica Salernitana /ID# 274319Salerno, ItalyContact: Caterina GolottaTaking people
- IRCCS Oasi SS. Troina /ID# 273507Troina, ItalyContact: Caterina GolottaTaking people
- A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 273276Turin, ItalyContact: Caterina GolottaTaking people
- Azienda Ulss 3 Serenissima /ID# 273027Venice, ItalyContact: Caterina GolottaTaking people
About the trial
What the trial wants to find out
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 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.
The group in the trial
- Foslevodopa/Foscarbidopa
Participants will receive Foslevodopa/Foscarbidopa as prescribed by their physician according to local label.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Foslevodopa/Foscarbidopa REal-world Evidence in Parkinson's Disease Quality of LIFE Outcomes
- Plain-language title
- Study of foslevodopa/foscarbidopa in adults with advanced Parkinson disease in ItalyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 13 May 2026