RecruitingNCT06965374

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

Sponsor

AbbVie

Enrollment

270 participants

Start Date

Jun 4, 2025

Study Type

OBSERVATIONAL

Conditions

Parkinson Disease

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. 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is observing quality-of-life outcomes in people with advanced Parkinson's disease who are being treated with a continuous under-the-skin (subcutaneous) infusion of levodopa/carbidopa — a medication that controls Parkinson's symptoms — in real-world clinical settings. **You may be eligible if...** - You have advanced Parkinson's disease that responds to levodopa treatment - Your doctor has already independently decided to prescribe the subcutaneous levodopa/carbidopa infusion as part of your standard care - You are being treated according to the approved guidelines for this medication **You may NOT be eligible if...** - You have a medical condition listed as a contraindication for this medication - You are enrolled in another interventional clinical trial involving this drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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