Informations générales (source: ClinicalTrials.gov)
Effectiveness aNd Use of fosleVOdopa-foscarbidopa in Advanced Parkinson Disease in Real Life Setting (ENVOL)
Observational
AbbVie (Voir sur ClinicalTrials)
novembre 2024
mars 2027
27 mars 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Cabinet de Neurologie /ID# 268309 - 78000 - Versailles - Yvelines - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier d'Avignon /ID# 266369 - 84000 - Avignon - Provence-Alpes-Cote-d Azur - France | Contact (sur clinicalTrials) | ||||
| Centre hospitalier de Brive /ID# 265952 - 19100 - Brive la Gaillarde - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de la Côte Basque /ID# 266846 - 64109 - Bayonne - Pyrenees-Atlantiques - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Saint Malo /ID# 265948 - 35403 - St Malo CEDEX - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Valenciennes /ID# 266400 - 59300 - Valenciennes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Emile Durkheim - Site Plateau de la Justice /ID# 267183 - 88021 - Epinal CEDEX - Vosges - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Public du Cotentin - Hôpital Pasteur /ID# 265950 - 50102 - Cherbourg-en-Cotentin - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Régional Universitaire de Besançon - Hôpital Jean Minjoz /ID# 266853 - 25000 - Besancon - Doubs - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro /ID# 265954 - 59037 - Lille - Hauts-de-France - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau /ID# 266375 - 30029 - Nîmes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou /ID# 267665 - 35033 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Ch Bethune - Beuvry /Id# 265994 - 62408 - Bethune CEDEX - France | Contact (sur clinicalTrials) | ||||
| CH Bretagne Atlantique /ID# 268308 - 56000 - Vannes - Morbihan - France | Contact (sur clinicalTrials) | ||||
| CH de Saint-Brieuc, Paimpol et Tréguier /ID# 266927 - 22027 - St Brieuc CEDEX 1 - Bretagne - France | Contact (sur clinicalTrials) | ||||
| CH Haguenau /ID# 266029 - 67500 - Haguenau - France | Contact (sur clinicalTrials) | ||||
| CHRU de NANCY /ID# 266385 - 54035 - Nancy CEDEX - France | Contact (sur clinicalTrials) | ||||
| CHU Amiens-Picardie Site Sud /ID# 266039 - 80000 - Amiens - Somme - France | Contact (sur clinicalTrials) | ||||
| CHU Brest /ID# 266405 - 29200 - Brest - Finistere - France | Contact (sur clinicalTrials) | ||||
| Chu de Limoges /Id# 266043 - 87042 - Limoges cedex - Franche-Comte - France | Contact (sur clinicalTrials) | ||||
| CHU de Nantes - Hopital Nord Laennec /ID# 266036 - 44800 - St Herblain - France | Contact (sur clinicalTrials) | ||||
| CHU de Rouen /ID# 266390 - 76031 - Rouen CEDEX - France | Contact (sur clinicalTrials) | ||||
| Chu Toulouse Purpan - Hopital Pierre Paul Riquet /ID# 266031 - 31000 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Clinique Beausoleil /ID# 266920 - 34070 - Montpellier - Herault - France | Contact (sur clinicalTrials) | ||||
| Hôpital La Timone /ID# 265932 - 13885 - Marseille - Bouches-du-Rhone - France | Contact (sur clinicalTrials) | ||||
| Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 266932 - 68024 - Colmar CEDEX - Grand-Est - France | Site Coordinator | Contact (sur clinicalTrials) | |||
| Les Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre /ID# 266843 - 67200 - Strasbourg - Alsace - France | Contact (sur clinicalTrials) | ||||
| les Hospices Civils de Lyon (HCL) /ID# 266404 - 69229 - Lyon CEDEX 02 - Rhone - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- Participants with any contraindication to foscarbidopa / foslevodopa.
- Participants with Mini mental state examination (MMSE) score < 24