Clinical trial NCT06639620: Study To Assess Effectiveness and Adverse Events of Foscarbidopa/ Foslevodopa in Adult Participants With Advanced Parkinson Disease in Real Life Setting
Official title: Effectiveness aNd Use of fosleVOdopa-foscarbidopa in Advanced Parkinson Disease in Real Life Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Parkinson Disease
Keywords: Advanced Parkinson disease
Foscarbidopa/ foslevodopa
ABBV-951
LDp/CDp
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with advanced Parkinson disease treated with Foscarbidopa/ foslevodopa according to label in France

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.


Eligibility criteria: 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 outcomes:
measure: Change From Baseline in Parkinson's Disease Questionnaire-8 (PDQ) total score.
timeFrame: Up to approximately 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre /ID# 266843
state: Alsace
city: Marseille
country: France
facility: Hôpital La Timone /ID# 265932
state: Bouches-du-Rhone
city: St Brieuc CEDEX 1
country: France
facility: CH de Saint-Brieuc, Paimpol et Tréguier /ID# 266927
state: Bretagne
city: Besancon
country: France
facility: Centre Hospitalier Régional Universitaire de Besançon - Hôpital Jean Minjoz /ID# 266853
state: Doubs
city: Brest
country: France
facility: CHU Brest /ID# 266405
state: Finistere
city: Limoges cedex
country: France
facility: Chu de Limoges /Id# 266043
state: Franche-Comte
city: Colmar CEDEX
country: France
facility: Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 266932
state: Grand-Est
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro /ID# 265954
state: Hauts-de-France
city: Montpellier
country: France
facility: Clinique Beausoleil /ID# 266920
state: Herault
city: Vannes
country: France
facility: CH Bretagne Atlantique /ID# 268308
state: Morbihan
city: Avignon
country: France
facility: Centre Hospitalier d'Avignon /ID# 266369
state: Provence-Alpes-Cote-d Azur
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque /ID# 266846
state: Pyrenees-Atlantiques
city: Lyon CEDEX 02
country: France
facility: les Hospices Civils de Lyon (HCL) /ID# 266404
state: Rhone
city: Amiens
country: France
facility: CHU Amiens-Picardie Site Sud /ID# 266039
state: Somme
city: Epinal CEDEX
country: France
facility: Centre Hospitalier Emile Durkheim - Site Plateau de la Justice /ID# 267183
state: Vosges
city: Versailles
country: France
facility: Cabinet de Neurologie /ID# 268309
state: Yvelines
city: Bethune CEDEX
country: France
facility: Ch Bethune - Beuvry /Id# 265994
city: Brive la Gaillarde
country: France
facility: Centre hospitalier de Brive /ID# 265952
city: Cherbourg-en-Cotentin
country: France
facility: Centre Hospitalier Public du Cotentin - Hôpital Pasteur /ID# 265950
city: Haguenau
country: France
facility: CH Haguenau /ID# 266029
city: Nancy CEDEX
country: France
facility: CHRU de NANCY /ID# 266385
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau /ID# 266375
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild /ID# 266373
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou /ID# 267665
city: Rouen CEDEX
country: France
facility: CHU de Rouen /ID# 266390
city: St Herblain
country: France
facility: CHU de Nantes - Hopital Nord Laennec /ID# 266036
city: St Malo CEDEX
country: France
facility: Centre Hospitalier de Saint Malo /ID# 265948
city: Toulouse
country: France
facility: Chu Toulouse Purpan - Hopital Pierre Paul Riquet /ID# 266031
city: Valenciennes
country: France
facility: Centre Hospitalier de Valenciennes /ID# 266400
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: