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

February 24, 2026 updated by: AbbVie

Effectiveness aNd Use of fosleVOdopa-foscarbidopa in 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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brive-la-Gaillarde, France, 19100
        • Centre hospitalier de Brive /ID# 265952
      • Cherbourg, France, 50102
        • Centre Hospitalier Public du Cotentin - Hôpital Pasteur /ID# 265950
      • Haguenau, France, 67500
        • CH Haguenau /ID# 266029
      • Nancy, France, 54035
        • CHRU de NANCY /ID# 266385
      • Paris, France, 75019
        • Hôpital Fondation Adolphe de Rothschild /ID# 266373
      • Rouen, France, 76031
        • CHU de Rouen /ID# 266390
      • Saint-Herblain, France, 44800
        • CHU de Nantes - Hopital Nord Laennec /ID# 266036
      • St-Malo, France, 35403
        • Centre Hospitalier de Saint Malo /ID# 265948
      • Valenciennes, France, 59300
        • Centre Hospitalier de Valenciennes /ID# 266400
    • Alsace
      • Strasbourg, Alsace, France, 67200
        • Les Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre /ID# 266843
    • Auvergne-Rhône-Alpes
      • Clermont-Ferrand, Auvergne-Rhône-Alpes, France, 63000
        • Centre Hospitalier Universitaire Gabriel-Montpied /ID# 267182
      • Lyon, Auvergne-Rhône-Alpes, France, 69002
        • Hospices Civils De Lyon - Direction Des Affaires Médicales /ID# 266404
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13885
        • Hôpital La Timone /ID# 265932
    • Brittany Region
      • Saint-Brieuc, Brittany Region, France, 22027
        • CH de Saint-Brieuc, Paimpol et Tréguier /ID# 266927
    • Doubs
      • Besançon, Doubs, France, 25000
        • Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz /ID# 266853
    • Finistere
      • Brest, Finistere, France, 29200
        • CHU Brest /ID# 266405
    • Franche-Comte
      • Limoges, Franche-Comte, France, 87042
        • Chu de Limoges /Id# 266043
    • Gard
      • Nîmes, Gard, France, 30029
        • Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau /ID# 266375
    • Grand Est
      • Colmar, Grand Est, France, 68024
        • Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 266932
    • Hauts-de-France
      • Béthune, Hauts-de-France, France, 62408
        • Centre Hospitalier de Bethune /ID# 265994
      • Lille, Hauts-de-France, France, 59037
        • Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro /ID# 265954
    • Herault
      • Montpellier, Herault, France, 34070
        • Clinique Beausoleil /ID# 266920
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35033
        • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou /ID# 267665
      • St-Malo, Ille-et-Vilaine, France, 35400
        • Cabinet de Neurologie des Drs Bonnet et Leguy Bonnet /ID# 276582
    • Morbihan
      • Vannes, Morbihan, France, 56000
        • CH Bretagne Atlantique /ID# 268308
    • Occitanie
      • Toulouse, Occitanie, France, 31059
        • Chu De Toulouse - Hopital Pierre Paul Ricquet /ID# 266031
    • Paris
      • Créteil, Paris, France, 94010
        • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 266034
    • Provence-Alpes-Côte d'Azur Region
      • Avignon, Provence-Alpes-Côte d'Azur Region, France, 84000
        • Centre Hospitalier d'Avignon /ID# 266369
    • Pyrenees-Atlantiques
      • Bayonne, Pyrenees-Atlantiques, France, 64109
        • Centre Hospitalier de la Côte Basque /ID# 266846
    • Somme
      • Amiens, Somme, France, 80054
        • CHU Amiens-Picardie Site Sud /ID# 266039
    • Var
      • Toulon, Var, France, 83000
        • Centre Hospitalier Intercommunal Toulon /ID# 266397
    • Vosges
      • Épinal, Vosges, France, 88021
        • Centre Hospitalier Emile Durkheim - Site Plateau de la Justice /ID# 267183
    • Yvelines
      • Versailles, Yvelines, France, 78000
        • Cabinet de Neurologie /ID# 268309

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with advanced Parkinson disease treated with Foscarbidopa/ foslevodopa according to label in France

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Foscarbidopa / Foslevodopa
Participants will receive foscarbidopa/ foslevodopa as prescribed by their physician according to local label

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

October 11, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P24-820

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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