Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Azienda Ospedaliero Universitaria delle Marche /ID# 272694
Coordinator of this site? Confirm its status
AnconaItalyRecruiting
Ospedale Bellaria - Azienda Usl Di Bologna /ID# 274463
Coordinator of this site? Confirm its status
BolognaItalyRecruiting
IRCCS Centro Neurolesi Bonino Pulejo /ID# 273628
Coordinator of this site? Confirm its status
MessinaItalyRecruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 273225
Coordinator of this site? Confirm its status
MilanItalyRecruiting
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 272949
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273434
Coordinator of this site? Confirm its status
NaplesItalyRecruiting
Azienda Ospedale-Universita Padova /ID# 274317
Coordinator of this site? Confirm its status
PadovaItalyRecruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 272863
Coordinator of this site? Confirm its status
PalermoItalyRecruiting
Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 274226
Coordinator of this site? Confirm its status
PaviaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana /ID# 273541
Coordinator of this site? Confirm its status
PisaItalyRecruiting
Istituto Neurologico Mediterraneo Neuromed S.P.A. - Irccs /Id# 272695
Coordinator of this site? Confirm its status
PozzilliItalyRecruiting
AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 274388
Coordinator of this site? Confirm its status
Reggio EmiliaItalyRecruiting
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 272834
Coordinator of this site? Confirm its status
RomeItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274539
Coordinator of this site? Confirm its status
RomeItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 273562
Coordinator of this site? Confirm its status
RomeItalyRecruiting
AOU San Giovanni di Dio Ruggi d'Aragona - Scuola Medica Salernitana /ID# 274319
Coordinator of this site? Confirm its status
SalernoItalyRecruiting
IRCCS Oasi SS. Troina /ID# 273507
Coordinator of this site? Confirm its status
TroinaItalyRecruiting
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 273276
Coordinator of this site? Confirm its status
TurinItalyRecruiting
Azienda Ulss 3 Serenissima /ID# 273027
Coordinator of this site? Confirm its status
VeniceItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.