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

NCT ID: NCT06639620

Last Updated: 2025-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-12

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Foscarbidopa / Foslevodopa

Participants will receive foscarbidopa/ foslevodopa as prescribed by their physician according to local label

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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

Strasbourg, Alsace, France

Site Status RECRUITING

Centre Hospitalier Universitaire Gabriel-Montpied /ID# 267182

Clermont-Ferrand, Auvergne-Rhône-Alpes, France

Site Status RECRUITING

Hôpital La Timone /ID# 265932

Marseille, Bouches-du-Rhone, France

Site Status RECRUITING

CH de Saint-Brieuc, Paimpol et Tréguier /ID# 266927

Saint-Brieuc, Brittany Region, France

Site Status RECRUITING

Centre Hospitalier Régional Universitaire de Besançon - Hôpital Jean Minjoz /ID# 266853

Besançon, Doubs, France

Site Status RECRUITING

CHU Brest /ID# 266405

Brest, Finistere, France

Site Status RECRUITING

Chu de Limoges /Id# 266043

Limoges, Franche-Comte, France

Site Status RECRUITING

Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 266932

Colmar, Grand Est, France

Site Status RECRUITING

Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro /ID# 265954

Lille, Hauts-de-France, France

Site Status RECRUITING

Clinique Beausoleil /ID# 266920

Montpellier, Herault, France

Site Status RECRUITING

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou /ID# 267665

Rennes, Ille-et-Vilaine, France

Site Status RECRUITING

CH Bretagne Atlantique /ID# 268308

Vannes, Morbihan, France

Site Status RECRUITING

Chu De Toulouse - Hopital Pierre Paul Ricquet /ID# 266031

Toulouse, Occitanie, France

Site Status RECRUITING

Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 266034

Créteil, Paris, France

Site Status RECRUITING

Centre Hospitalier d'Avignon /ID# 266369

Avignon, Provence-Alpes-Côte d'Azur Region, France

Site Status RECRUITING

Centre Hospitalier de la Côte Basque /ID# 266846

Bayonne, Pyrenees-Atlantiques, France

Site Status RECRUITING

les Hospices Civils de Lyon (HCL) /ID# 266404

Lyon, Rhone, France

Site Status RECRUITING

CHU Amiens-Picardie Site Sud /ID# 266039

Amiens, Somme, France

Site Status RECRUITING

Centre Hospitalier Intercommunal Toulon /ID# 266397

Toulon, Var, France

Site Status RECRUITING

Centre Hospitalier Emile Durkheim - Site Plateau de la Justice /ID# 267183

Épinal, Vosges, France

Site Status RECRUITING

Cabinet de Neurologie /ID# 268309

Versailles, Yvelines, France

Site Status RECRUITING

Ch Bethune - Beuvry /Id# 265994

Béthune, , France

Site Status RECRUITING

Centre hospitalier de Brive /ID# 265952

Brive-la-Gaillarde, , France

Site Status RECRUITING

Centre Hospitalier Public du Cotentin - Hôpital Pasteur /ID# 265950

Cherbourg, , France

Site Status RECRUITING

CH Haguenau /ID# 266029

Haguenau, , France

Site Status RECRUITING

CHRU de NANCY /ID# 266385

Nancy, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau /ID# 266375

Nîmes, , France

Site Status RECRUITING

Hôpital Fondation Adolphe de Rothschild /ID# 266373

Paris, , France

Site Status RECRUITING

CHU de Rouen /ID# 266390

Rouen, , France

Site Status RECRUITING

CHU de Nantes - Hopital Nord Laennec /ID# 266036

Saint-Herblain, , France

Site Status RECRUITING

Centre Hospitalier de Saint Malo /ID# 265948

St-Malo, , France

Site Status COMPLETED

Centre Hospitalier de Valenciennes /ID# 266400

Valenciennes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sophie Carret Costin

Role: CONTACT

+33 145 60 1498

Facility Contacts

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Site Coordinator

Role: primary

03 89 12 41 55

Related Links

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Other Identifiers

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P24-820

Identifier Type: -

Identifier Source: org_study_id

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