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

NCT06639620 | Active Not Recruiting

• 1 other identifier: P24-820
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 33

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.

Conditions

Advanced Parkinson Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (1)

Foscarbidopa / Foslevodopa

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (33)

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

Strasbourg, Alsace, 67200, France

Location

Centre Hospitalier Universitaire Gabriel-Montpied /ID# 267182

Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000, France

Location

Hospices Civils De Lyon - Direction Des Affaires Médicales /ID# 266404

Lyon, Auvergne-Rhône-Alpes, 69002, France

Location

Hôpital La Timone /ID# 265932

Marseille, Bouches-du-Rhone, 13885, France

Location

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

Saint-Brieuc, Brittany Region, 22027, France

Location

Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz /ID# 266853

Besançon, Doubs, 25000, France

Location

CHU Brest /ID# 266405

Brest, Finistere, 29200, France

Location

Chu de Limoges /Id# 266043

Limoges, Franche-Comte, 87042, France

Location

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

Nîmes, Gard, 30029, France

Location

Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 266932

Colmar, Grand Est, 68024, France

Location

Centre Hospitalier de Bethune /ID# 265994

Béthune, Hauts-de-France, 62408, France

Location

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

Lille, Hauts-de-France, 59037, France

Location

Clinique Beausoleil /ID# 266920

Montpellier, Herault, 34070, France

Location

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

Rennes, Ille-et-Vilaine, 35033, France

Location

Cabinet de Neurologie des Drs Bonnet et Leguy Bonnet /ID# 276582

St-Malo, Ille-et-Vilaine, 35400, France

Location

CH Bretagne Atlantique /ID# 268308

Vannes, Morbihan, 56000, France

Location

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

Toulouse, Occitanie, 31059, France

Location

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

Créteil, Paris, 94010, France

Location

Centre Hospitalier d'Avignon /ID# 266369

Avignon, Provence-Alpes-Côte d'Azur Region, 84000, France

Location

Centre Hospitalier de la Côte Basque /ID# 266846

Bayonne, Pyrenees-Atlantiques, 64109, France

Location

CHU Amiens-Picardie Site Sud /ID# 266039

Amiens, Somme, 80054, France

Location

Centre Hospitalier Intercommunal Toulon /ID# 266397

Toulon, Var, 83000, France

Location

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

Épinal, Vosges, 88021, France

Location

Cabinet de Neurologie /ID# 268309

Versailles, Yvelines, 78000, France

Location

Centre hospitalier de Brive /ID# 265952

Brive-la-Gaillarde, 19100, France

Location

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

Cherbourg, 50102, France

Location

CH Haguenau /ID# 266029

Haguenau, 67500, France

Location

CHRU de NANCY /ID# 266385

Nancy, 54035, France

Location

Hôpital Fondation Adolphe de Rothschild /ID# 266373

Paris, 75019, France

Location

CHU de Rouen /ID# 266390

Rouen, 76031, France

Location

CHU de Nantes - Hopital Nord Laennec /ID# 266036

Saint-Herblain, 44800, France

Location

Centre Hospitalier de Saint Malo /ID# 265948

St-Malo, 35403, France

Location

Centre Hospitalier de Valenciennes /ID# 266400

Valenciennes, 59300, France

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

FR (33)