Assessing the effectiveness of foscarbidopa/foslevodopa in adults with advanced Parkinson's disease
Effectiveness aNd Use of fosleVOdopa-foscarbidopa in Advanced Parkinson Disease in Real Life Setting
This study is testing if a new treatment called foscarbidopa/foslevodopa can help adults with advanced Parkinson's disease feel better in a real-world setting.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 29 sites (Strasbourg, Alsace and 28 other locations) |
| Trial ID | NCT06639620 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness and adverse events of foscarbidopa/foslevodopa in treating adult participants with advanced Parkinson's disease in a real-world clinical setting. Approximately 200 participants will be enrolled across 30 sites in France, receiving subcutaneous infusions of the drug as prescribed by their physicians. Participants will be monitored for up to 12 months, attending regular visits at hospitals or clinics without any additional burden from the study.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced Parkinson's disease experiencing motor complications that are not adequately controlled by their current therapy.
Not a fit: Patients with contraindications to foscarbidopa/foslevodopa or a Mini Mental State Examination score below 24 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of foscarbidopa/foslevodopa for managing advanced Parkinson's disease symptoms.
How similar studies have performed: While foscarbidopa/foslevodopa is an approved treatment outside the US, this study's observational approach in a real-world setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Strasbourg, Alsace and 28 other locations
- Les Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre /ID# 266843 — Strasbourg, Alsace, France (Recruiting)
- Hôpital La Timone /ID# 265932 — Marseille, Bouches-du-Rhone, France (Recruiting)
- CH de Saint-Brieuc, Paimpol et Tréguier /ID# 266927 — St Brieuc CEDEX 1, Bretagne, France (Recruiting)
- Centre Hospitalier Régional Universitaire de Besançon - Hôpital Jean Minjoz /ID# 266853 — Besancon, Doubs, France (Recruiting)
- CHU Brest /ID# 266405 — Brest, Finistere, France (Recruiting)
- Chu de Limoges /Id# 266043 — Limoges cedex, Franche-Comte, France (Recruiting)
- Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 266932 — Colmar CEDEX, Grand-Est, France (Recruiting)
- Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro /ID# 265954 — Lille, Hauts-de-France, France (Recruiting)
- Clinique Beausoleil /ID# 266920 — Montpellier, Herault, France (Recruiting)
- CH Bretagne Atlantique /ID# 268308 — Vannes, Morbihan, France (Recruiting)
- Centre Hospitalier d'Avignon /ID# 266369 — Avignon, Provence-Alpes-Cote-d Azur, France (Recruiting)
- Centre Hospitalier de la Côte Basque /ID# 266846 — Bayonne, Pyrenees-Atlantiques, France (Recruiting)
- les Hospices Civils de Lyon (HCL) /ID# 266404 — Lyon CEDEX 02, Rhone, France (Recruiting)
- CHU Amiens-Picardie Site Sud /ID# 266039 — Amiens, Somme, France (Recruiting)
- Centre Hospitalier Emile Durkheim - Site Plateau de la Justice /ID# 267183 — Epinal CEDEX, Vosges, France (Recruiting)
- Cabinet de Neurologie /ID# 268309 — Versailles, Yvelines, France (Recruiting)
- Ch Bethune - Beuvry /Id# 265994 — Bethune CEDEX, France (Recruiting)
- Centre hospitalier de Brive /ID# 265952 — Brive la Gaillarde, France (Recruiting)
- Centre Hospitalier Public du Cotentin - Hôpital Pasteur /ID# 265950 — Cherbourg-en-Cotentin, France (Recruiting)
- CH Haguenau /ID# 266029 — Haguenau, France (Recruiting)
- CHRU de NANCY /ID# 266385 — Nancy CEDEX, France (Recruiting)
- Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau /ID# 266375 — Nîmes, France (Recruiting)
- Hôpital Fondation Adolphe de Rothschild /ID# 266373 — Paris, France (Recruiting)
- Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou /ID# 267665 — Rennes, France (Recruiting)
- CHU de Rouen /ID# 266390 — Rouen CEDEX, France (Recruiting)
- CHU de Nantes - Hopital Nord Laennec /ID# 266036 — St Herblain, France (Recruiting)
- Centre Hospitalier de Saint Malo /ID# 265948 — St Malo CEDEX, France (Recruiting)
- Chu Toulouse Purpan - Hopital Pierre Paul Riquet /ID# 266031 — Toulouse, France (Recruiting)
- Centre Hospitalier de Valenciennes /ID# 266400 — Valenciennes, France (Recruiting)
Study contacts
- Study coordinator: Sophie Carret Costin
- Email: sophie.carret@abbvie.com
- Phone: +33 145 60 1498
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.