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

Status: Recruiting
Location: See all (7) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Azienda Ospedaliero Universitaria delle Marche /ID# 272694
RECRUITING
Ancona
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 273225
RECRUITING
Milan
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 272863
RECRUITING
Palermo
Istituto Neurologico Mediterraneo Neuromed S.P.A. - Irccs /Id# 272695
RECRUITING
Pozzilli
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 273562
RECRUITING
Rome
AOU San Giovanni di Dio Ruggi d'Aragona - Scuola Medica Salernitana /ID# 274319
RECRUITING
Salerno
IRCCS Oasi SS. Troina /ID# 273507
RECRUITING
Troina
Contact Information
Primary
Caterina Golotta
caterina.golotta@abbvie.com
+39 06 548891
Time Frame
Start Date: 2025-06-04
Estimated Completion Date: 2027-06
Participants
Target number of participants: 270
Treatments
Foslevodopa/Foscarbidopa
Participants will receive Foslevodopa/Foscarbidopa as prescribed by their physician according to local label.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov