Real-World Study of Foslevodopa/Foscarbidopa to Assess Quality of Life Outcomes in Adult Participants With Advanced Parkinson Disease
Recruiting · NCT06965374 · Observational (researchers observe without assigning treatment) · Lead sponsor: AbbVie
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- Any condition included in the contraindications section of the approved local subcutaneous LDp/CDp label
- 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
- 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 it is running
19 locations listed.
- Azienda Ospedaliero Universitaria delle Marche /ID# 272694 - Ancona, Italy
- Ospedale Bellaria - Azienda Usl Di Bologna /ID# 274463 - Bologna, Italy
- IRCCS Centro Neurolesi Bonino Pulejo /ID# 273628 - Messina, Italy
- Azienda Ospedale-Universita Padova /ID# 274317 - Padova, Italy
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 272863 - Palermo, Italy
- Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 274226 - Pavia, Italy
- Azienda Ospedaliero Universitaria Pisana /ID# 273541 - Pisa, Italy
- AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 274388 - Reggio Emilia, Italy
- AOU San Giovanni di Dio Ruggi d'Aragona - Scuola Medica Salernitana /ID# 274319 - Salerno, Italy
- IRCCS Oasi SS. Troina /ID# 273507 - Troina, Enna, Italy
- Istituto Neurologico Mediterraneo Neuromed S.P.A. - Irccs /Id# 272695 - Pozzilli, Isernia, Italy
- ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 272949 - Milan, Milano, Italy
- Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 273225 - Milan, Milano, Italy
- Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273434 - Naples, Napoli, Italy
- A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 273276 - Turin, Piedmont, Italy
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 272834 - Rome, Roma, Italy
- Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 273562 - Rome, Roma, Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274539 - Rome, Roma, Italy
- Azienda Ulss 3 Serenissima /ID# 273027 - Venice, Venezia, Italy