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NCT Number: NCT06639620

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Parkinson Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Les Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre /ID# 266843, Strasbourg, Alsace, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change From Baseline in Parkinson's Disease Questionnaire-8 (PDQ) total score.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: ENVOL

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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