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Clinical Trials in France / NCT06639620
Active, not recruiting Observational

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

NCT06639620 · tracked via the Priya Life Science France tracker
Sponsor
AbbVie
Phase
Observational
Started
2024-11-12
Last updated
2026-02-27

Condition(s) studied

Advanced Parkinson Disease

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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.

Trial sites (33)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06639620 on ClinicalTrials.gov ↗ ← All trials in France