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RECRUITINGOBSERVATIONAL

Real-World Study of Foslevodopa/Foscarbidopa to Assess Quality of Life Outcomes in Adult Participants With Advanced Parkinson Disease

Foslevodopa/Foscarbidopa REal-world Evidence in Parkinson's Disease Quality of LIFE Outcomes

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Locations (19)

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
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