Actively Recruiting

Age: 18Years +
All Genders
NCT06965374

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

Led by AbbVie · Updated on 2026-05-13

270

Participants Needed

19

Research Sites

103 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants diagnosed with levodopa-responsive advanced Parkinson's disease
  • Investigator has decided to treat participant with subcutaneous Foslevodopa/Foscarbidopa before offering study participation
  • Subcutaneous Foslevodopa/Foscarbidopa treatment prescribed for 24 hours according to approved label and local rules
Not Eligible

You will not qualify if you...

  • Any condition listed as a contraindication in the approved subcutaneous Foslevodopa/Foscarbidopa label
  • Participation in a clinical trial of an investigational drug currently or within the last 30 days
  • History of relevant skin conditions or disorders judged by the investigator to interfere with infusion or assessments
  • Temporary skin conditions like recent sunburn, acne, scars, tattoos, open wounds, branding, or colorations considered interfering by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 19 locations

1

IRCCS Oasi SS. Troina /ID# 273507

Troina, Enna, Italy, 94018

Actively Recruiting

2

Istituto Neurologico Mediterraneo Neuromed S.P.A. - Irccs /Id# 272695

Pozzilli, Isernia, Italy, 86077

Actively Recruiting

3

ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 272949

Milan, Milano, Italy, 20122

Actively Recruiting

4

Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 273225

Milan, Milano, Italy, 20133

Actively Recruiting

5

Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273434

Naples, Napoli, Italy, 80138

Actively Recruiting

6

A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 273276

Turin, Piedmont, Italy, 10126

Actively Recruiting

7

Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 272834

Rome, Roma, Italy, 00133

Actively Recruiting

8

Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 273562

Rome, Roma, Italy, 00161

Actively Recruiting

9

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274539

Rome, Roma, Italy, 00168

Actively Recruiting

10

Azienda Ulss 3 Serenissima /ID# 273027

Venice, Venezia, Italy, 30100

Actively Recruiting

11

Azienda Ospedaliero Universitaria delle Marche /ID# 272694

Ancona, Italy, 60020

Actively Recruiting

12

Ospedale Bellaria - Azienda Usl Di Bologna /ID# 274463

Bologna, Italy, 40139

Actively Recruiting

13

IRCCS Centro Neurolesi Bonino Pulejo /ID# 273628

Messina, Italy, 98124

Actively Recruiting

14

Azienda Ospedale-Universita Padova /ID# 274317

Padova, Italy, 35128

Actively Recruiting

15

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 272863

Palermo, Italy, 90127

Actively Recruiting

16

Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 274226

Pavia, Italy, 27100

Actively Recruiting

17

Azienda Ospedaliero Universitaria Pisana /ID# 273541

Pisa, Italy, 56126

Actively Recruiting

18

AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 274388

Reggio Emilia, Italy, 42122

Actively Recruiting

19

AOU San Giovanni di Dio Ruggi d'Aragona - Scuola Medica Salernitana /ID# 274319

Salerno, Italy, 84131

Actively Recruiting

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Research Team

C

Caterina Golotta

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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