Advanced Parkinson DiseaseENVOLNCT06639620
Study To Assess Effectiveness and Adverse Events of Foscarbidopa/ Foslevodopa in Adult Participants With Advanced Parkinson Disease in Real Life Setting
An observational study of Advanced Parkinson Disease, run by AbbVie at 33 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Parkinson Disease
- How many people
- 250 participants
- Where
- 33 sitesFrance
- Study dates
- 12 Nov 2024to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with advanced Parkinson disease treated with Foscarbidopa/ foslevodopa according to label in France
Who may be able to join
- 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
Who cannot join
- Participants with any contraindication to foscarbidopa / foslevodopa.
- Participants with Mini mental state examination (MMSE) score < 24
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
France33 sites
CHU Amiens-Picardie Site Sud /ID# 266039
Amiens, Somme, 80054
Centre Hospitalier d'Avignon /ID# 266369
Avignon, Provence-Alpes-Côte d'Azur Region, 84000
Centre Hospitalier de la Côte Basque /ID# 266846
Bayonne, Pyrenees-Atlantiques, 64109
Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz /ID# 266853
Besançon, Doubs, 25000
Centre Hospitalier de Bethune /ID# 265994
Béthune, Hauts-de-France, 62408
CHU Brest /ID# 266405
Brest, Finistere, 29200
Centre hospitalier de Brive /ID# 265952
Brive-la-Gaillarde, 19100
Centre Hospitalier Public du Cotentin - Hôpital Pasteur /ID# 265950
Cherbourg, 50102
Centre Hospitalier Universitaire Gabriel-Montpied /ID# 267182
Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000
Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 266932
Colmar, Grand Est, 68024
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 266034
Créteil, Paris, 94010
Centre Hospitalier Emile Durkheim - Site Plateau de la Justice /ID# 267183
Épinal, Vosges, 88021
CH Haguenau /ID# 266029
Haguenau, 67500
Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro /ID# 265954
Lille, Hauts-de-France, 59037
Chu de Limoges /Id# 266043
Limoges, Franche-Comte, 87042
Hospices Civils De Lyon - Direction Des Affaires Médicales /ID# 266404
Lyon, Auvergne-Rhône-Alpes, 69002
Hôpital La Timone /ID# 265932
Marseille, Bouches-du-Rhone, 13885
Clinique Beausoleil /ID# 266920
Montpellier, Herault, 34070
CHRU de NANCY /ID# 266385
Nancy, 54035
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau /ID# 266375
Nîmes, Gard, 30029
Hôpital Fondation Adolphe de Rothschild /ID# 266373
Paris, 75019
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou /ID# 267665
Rennes, Ille-et-Vilaine, 35033
CHU de Rouen /ID# 266390
Rouen, 76031
CH de Saint-Brieuc, Paimpol et Tréguier /ID# 266927
Saint-Brieuc, Brittany Region, 22027
CHU de Nantes - Hopital Nord Laennec /ID# 266036
Saint-Herblain, 44800
Cabinet de Neurologie des Drs Bonnet et Leguy Bonnet /ID# 276582
St-Malo, Ille-et-Vilaine, 35400
Centre Hospitalier de Saint Malo /ID# 265948
St-Malo, 35403
Les Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre /ID# 266843
Strasbourg, Alsace, 67200
Centre Hospitalier Intercommunal Toulon /ID# 266397
Toulon, Var, 83000
Chu De Toulouse - Hopital Pierre Paul Ricquet /ID# 266031
Toulouse, Occitanie, 31059
Centre Hospitalier de Valenciennes /ID# 266400
Valenciennes, 59300
CH Bretagne Atlantique /ID# 268308
Vannes, Morbihan, 56000
Cabinet de Neurologie /ID# 268309
Versailles, Yvelines, 78000
About this study
Official title: Effectiveness aNd Use of fosleVOdopa-foscarbidopa in Advanced Parkinson Disease in Real Life Setting
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.
Read more
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.
- Conditions
- Advanced Parkinson Disease
- Keywords
- Advanced Parkinson disease, Foscarbidopa/ foslevodopa, ABBV-951, LDp/CDp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Foscarbidopa / Foslevodopa | Participants will receive foscarbidopa/ foslevodopa as prescribed by their physician according to local label |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Parkinson's Disease Questionnaire-8 (PDQ) total score.
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.
Measured: Up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start12 Nov 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639620
- Sponsor's protocol ID
- P24-820
- Acronym
- ENVOL
- Status last verified
- Feb 2026
- First submitted
- 11 Oct 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness aNd Use of fosleVOdopa-foscarbidopa in Advanced Parkinson Disease in Real Life Setting
- ClinicalTrials.gov ID
- NCT06639620
- Acronym / sponsor ID
- ENVOL / P24-820
- Conditions
- Advanced Parkinson Disease
- Keywords
- Advanced Parkinson disease, Foscarbidopa/ foslevodopa, ABBV-951, LDp/CDp
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foscarbidopa / Foslevodopa | – | –Participants will receive foscarbidopa/ foslevodopa as prescribed by their physician according to local label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with advanced Parkinson disease treated with Foscarbidopa/ foslevodopa according to label in France
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Participants with any contraindication to foscarbidopa / foslevodopa.
- Participants with Mini mental state examination (MMSE) score < 24
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change From Baseline in Parkinson's Disease Questionnaire-8 (PDQ) total score.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Parkinson Disease, run by AbbVie at 33 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Parkinson's Disease Questionnaire-8 (PDQ) total score. (time frame: Up to approximately 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.