A Study to Assess Change in Disease Symptoms in Adult Participants With Advanced Parkinson Disease Using Subcutaneous Foslevodopa/Foscarbidopa in Belgium (ProParkB)

AbbVie

Status: Not yet enrolling

Conditions: Parkinson's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT07382440

P26-053

Details and patient eligibility

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 adult participants with advanced Parkinson Disease under routine clinical practice in Belgium.

Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 120 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled at 15 sites across Belgium.

Participants will receive Foslevodopa/Foscarbidopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 18 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant diagnosed with Advanced Parkinson's Disease (PD), aged 18 years or older able to provide voluntary informed consent.
• Participant evaluated for commercially available continuous subcutaneous Foslevodopa/Foscarbidopa (LDp/CDp) in the hospital at the clinician's discretion as part of his/her routine clinical care and the intention to administer subcutaneous LDp/CDp made prior to and independent of recruitment into the study.

Exclusion criteria

• Participant participating in an interventional research study (not including noninterventional studies) during the administration of LDp/CDp.
• Participant evaluated for commercially available continuous subcutaneous LD/CDp outside of the hospital.

Trial design

120 participants in 1 patient group

Foslevodopa/Foscarbidopa

Description:

Participants will receive Foslevodopa/Foscarbidopa as prescribed by their physician according to local label.