Study To Assess Effectiveness and Adverse Events of Foscarbidopa/ Foslevodopa in Adult Participants With Advanced Parkinson Disease in Real Life Setting
Launched by ABBVIE · Oct 11, 2024
Trial Information
Current as of June 28, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how well a medication called foscarbidopa/foslevodopa works for adults with advanced Parkinson's disease in a real-world setting. Parkinson's disease is a condition that affects the brain and leads to symptoms like shaking, stiffness, and slow movements. The study will involve about 200 participants across 30 locations in France who are already prescribed this medication by their doctors. The goal is to see how effective the treatment is over a period of up to 12 months.
To be eligible for the trial, participants must have advanced Parkinson's disease and still experience motor problems that their current treatments aren't controlling well enough. They also need to meet specific guidelines for the medication. During the study, participants won’t face extra burdens; they will simply continue with their regular doctor visits as they receive the treatment. It's important to note that participants should not have any health issues that would prevent them from using the medication or have certain cognitive impairments.
Gender
ALL
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
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Avignon, Provence Alpes Cote D Azur, France
Bayonne, Pyrenees Atlantiques, France
Versailles, Yvelines, France
Haguenau, , France
Nancy Cedex, , France
Nîmes, , France
Paris, , France
St Malo Cedex, , France
Strasbourg, Alsace, France
Lille, Hauts De France, France
Montpellier, Herault, France
Brive La Gaillarde, , France
St Brieuc Cedex 1, Bretagne, France
Brest, Finistere, France
Limoges Cedex, Franche Comte, France
Colmar Cedex, Grand Est, France
Vannes, Morbihan, France
Lyon Cedex 02, Rhone, France
Amiens, Somme, France
Bethune Cedex, , France
Rouen Cedex, , France
St Herblain, , France
Toulouse, , France
Valenciennes, , France
Marseille, Bouches Du Rhone, France
Besancon, Doubs, France
Epinal Cedex, Vosges, France
Cherbourg En Cotentin, , France
Rennes, , France
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported