Study To Assess Effectiveness and Adverse Events of Foscarbidopa/ Foslevodopa in Adult Participants With Advanced Parkinson Disease in Real Life Setting
- Conditions
- Advanced Parkinson Disease
- Registration Number
- NCT06639620
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Centre Hospitalier Emile Durkheim - Site Plateau de la Justice /ID# 267183
馃嚝馃嚪Epinal CEDEX, Vosges, France
Centre Hospitalier Public du Cotentin - H么pital Pasteur /ID# 265950
馃嚝馃嚪Cherbourg-en-Cotentin, France
Centre Hospitalier Universitaire de Rennes - H么pital Pontchaillou /ID# 267665
馃嚝馃嚪Rennes, France
Les H么pitaux Universitaires de Strasbourg - H么pital de Hautepierre /ID# 266843
馃嚝馃嚪Strasbourg, Alsace, France
H么pital La Timone /ID# 265932
馃嚝馃嚪Marseille, Bouches-du-Rhone, France
CH de Saint-Brieuc, Paimpol et Tr茅guier /ID# 266927
馃嚝馃嚪St Brieuc CEDEX 1, Bretagne, France
Centre Hospitalier R茅gional Universitaire de Besan莽on - H么pital Jean Minjoz /ID# 266853
馃嚝馃嚪Besancon, Doubs, France
CHU Brest /ID# 266405
馃嚝馃嚪Brest, Finistere, France
Chu de Limoges /Id# 266043
馃嚝馃嚪Limoges cedex, Franche-Comte, France
H么pitaux Civils de Colmar - H么pital Pasteur /ID# 266932
馃嚝馃嚪Colmar CEDEX, Grand-Est, France
Centre Hospitalier R茅gional Universitaire de Lille - H么pital Roger Salengro /ID# 265954
馃嚝馃嚪Lille, Hauts-de-France, France
Clinique Beausoleil /ID# 266920
馃嚝馃嚪Montpellier, Herault, France
CH Bretagne Atlantique /ID# 268308
馃嚝馃嚪Vannes, Morbihan, France
Centre Hospitalier d'Avignon /ID# 266369
馃嚝馃嚪Avignon, Provence-Alpes-Cote-d Azur, France
Centre Hospitalier de la C么te Basque /ID# 266846
馃嚝馃嚪Bayonne, Pyrenees-Atlantiques, France
les Hospices Civils de Lyon (HCL) /ID# 266404
馃嚝馃嚪Lyon CEDEX 02, Rhone, France
CHU Amiens-Picardie Site Sud /ID# 266039
馃嚝馃嚪Amiens, Somme, France
Cabinet de Neurologie /ID# 268309
馃嚝馃嚪Versailles, Yvelines, France
Ch Bethune - Beuvry /Id# 265994
馃嚝馃嚪Bethune CEDEX, France
Centre hospitalier de Brive /ID# 265952
馃嚝馃嚪Brive la Gaillarde, France
CH Haguenau /ID# 266029
馃嚝馃嚪Haguenau, France
CHRU de NANCY /ID# 266385
馃嚝馃嚪Nancy CEDEX, France
Centre Hospitalier Universitaire de N卯mes - H么pital Universitaire Car茅meau /ID# 266375
馃嚝馃嚪N卯mes, France
H么pital Fondation Adolphe de Rothschild /ID# 266373
馃嚝馃嚪Paris, France
CHU de Rouen /ID# 266390
馃嚝馃嚪Rouen CEDEX, France
CHU de Nantes - Hopital Nord Laennec /ID# 266036
馃嚝馃嚪St Herblain, France
Centre Hospitalier de Saint Malo /ID# 265948
馃嚝馃嚪St Malo CEDEX, France
Chu Toulouse Purpan - Hopital Pierre Paul Riquet /ID# 266031
馃嚝馃嚪Toulouse, France
Centre Hospitalier de Valenciennes /ID# 266400
馃嚝馃嚪Valenciennes, France