Study To Assess Effectiveness and Adverse Events of Foscarbidopa/ Foslevodopa in Adult Participants With Advanced Parkinson Disease in Real Life Setting

Effectiveness aNd Use of fosleVOdopa-foscarbidopa in Advanced Parkinson Disease in Real Life Setting

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06639620

Acronym

ENVOL

Enrollment

250

Registered

2024-10-15

Start date

2024-11-12

Completion date

2027-03-01

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Parkinson Disease

Keywords

Advanced Parkinson disease, Foscarbidopa/ foslevodopa, ABBV-951, LDp/CDp

Brief 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 foscarbidopa/ foslevodopa is in treating French adult participants with advanced Parkinson disease under routine clinical practice. Foslevodopa/foscarbidopa is an approved drug outside of US for the treatment of Parkinson's Disease. Approximately 200 adult participants who are prescribed foslevodopa/foscarbidopa by their doctors will be enrolled across approximately 30 sites in France. Participants will receive foscarbidopa/ foslevodopa 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participants with advanced Parkinson disease with motor complications insufficiently controlled by current therapy * Participants eligible for foscarbidopa / foslevodopa according to French label \& regulation. * Treatment initiation decision prior to and independently from study enrolment

Exclusion criteria

* Participants with any contraindication to foscarbidopa / foslevodopa. * Participants with Mini mental state examination (MMSE) score \< 24

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Parkinson's Disease Questionnaire-8 (PDQ) total score.	Up to approximately 12 months	Parkinson Disease Questionnaire (PDQ)-8 is an eight-question instrument constructed by taking one question from each domain of PDQ-39: mobility, activities of daily of living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Each question is scored between 0 and 4 as follows: 0=Never and 4 = Always or cannot do at all. A higher score signifies poorer quality of life.

Countries

France

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results