NCT06965374Recruiting
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
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 270 (estimated)
- First submitted
- 2 May 2025
- Start date
- 4 Jun 2025
- Primary completion date
- Jun 2027
- Lead sponsor
- AbbVie
- Diseases
- Parkinson disease
- NCT number
- NCT06965374
What you commit to
- Study type: Observational
- Planned participants: 270
- From 4 Jun 2025 to the primary completion date, Jun 2027
- 19 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliero Universitaria delle Marche /ID# 272694 Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| Ospedale Bellaria - Azienda Usl Di Bologna /ID# 274463 Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| IRCCS Centro Neurolesi Bonino Pulejo /ID# 273628 Coordinator of this site? Confirm its status | Messina | Italy | Recruiting |
| Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 273225 Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 272949 Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273434 Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedale-Universita Padova /ID# 274317 Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 272863 Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 274226 Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana /ID# 273541 Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Istituto Neurologico Mediterraneo Neuromed S.P.A. - Irccs /Id# 272695 Coordinator of this site? Confirm its status | Pozzilli | Italy | Recruiting |
| AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 274388 Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 272834 Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274539 Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 273562 Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| AOU San Giovanni di Dio Ruggi d'Aragona - Scuola Medica Salernitana /ID# 274319 Coordinator of this site? Confirm its status | Salerno | Italy | Recruiting |
| IRCCS Oasi SS. Troina /ID# 273507 Coordinator of this site? Confirm its status | Troina | Italy | Recruiting |
| A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 273276 Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| Azienda Ulss 3 Serenissima /ID# 273027 Coordinator of this site? Confirm its status | Venice | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.