Parkinson's DiseaseNCT06916507
Study to Assess Real Life Effectiveness of Foslevodopa/Foscarbidopa in Adult German Participants at Initial Stages of Advanced Parkinson's Disease (EARLY-FOS)
An observational study of Parkinson's Disease, run by AbbVie at 19 sites in Germany.
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 to 67 years
- Conditions the study is for
- Parkinson's Disease
- How many people
- 125 participants
- Where
- 19 sitesGermany
- Study dates
- 5 May 2025to Jun 2028
- 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 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with advanced Parkinson's disease with time since the beginning of motor fluctuations <= 5 years and the Hoehn and Yahr (H\&Y) stage <= 3 in the on-medication condition treated with foslevodopa/foscarbidopa according to label in Germany
Who may be able to join
- Participants with a diagnosis of levodopa-responsive idiopathic Parkinson's disease
- Eligibility for foscarbidopa/foslevodopa (LDp/CDp) therapy in accordance with the approved local label
- Participant must be an adult male or female, 18-67 years of age
- Time since beginning of motor fluctuations <= 5 years
- The Hoehn and Yahr (H\&Y) stage <= 3
- Decision to treat with LDp/CDp made by the clinician prior to any decision to approach the participant to participate in this study
Who cannot join
- Previous Exposure to any device-aided therapy (DAT).
- Any condition included in the contraindications section of the approved local LDp/CDp label.
- Participants with Mini mental state examination (MMSE) score < 24
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
Germany19 sites, 19 recruiting
- Recruiting
Kliniken Schmieder - Allensbach /ID# 285402
Allensbach, Baden-Wurttemberg, 78476
- Recruiting
Knappschaftskrankenhaus Bottrop /ID# 274284
Bottrop, North Rhine-Westphalia, 46242
- Recruiting
Klinikum Bremen-Nord /ID# 275822
Bremen, 28755
- Recruiting
Cellitinnen-NTC Neurologisches Therapiecentrum /ID# 277865
Cologne, North Rhine-Westphalia, 50668
- Recruiting
Klinikum Lippe Detmold /ID# 279451
Detmold, North Rhine-Westphalia, 32756
- Recruiting
Klinikum Dortmund Klinikzentrum Mitte /ID# 280222
Dortmund, North Rhine-Westphalia, 44137
- Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 274167
Dresden, Saxony, 01307
- Recruiting
Universitaetsklinikum Erlangen /ID# 280831
Erlangen, Bavaria, 91054
- Recruiting
Praxis MD Oehlwein /ID# 274222
Gera, Thuringia, 07551
- Recruiting
Krankenhaus Martha-Maria Halle-Dolau /ID# 274174
Halle, Saxony-Anhalt, 06120
- Recruiting
Universitaetsklinikum Heidelberg /ID# 274164
Heidelberg, Baden-Wurttemberg, 69120
- Recruiting
Klinikum Ingolstadt /ID# 280573
Ingolstadt, Bavaria, 85049
- Recruiting
Universitaetskliniken Giessen und Marburg /ID# 274224
Marburg, Hesse, 35043
- Recruiting
Klinikum der Universitaet Muenchen Grosshadern /ID# 274168
Munich, Bavaria, 81337
- Recruiting
Klinikum Ernst von Bergmann /ID# 274176
Potsdam, Brandenburg, 14467
- Recruiting
Asklepios Fachklinikum Stadtroda /ID# 274162
Stadtroda, Thuringia, 07646
- Recruiting
Universitaetsklinikum Tuebingen /ID# 275828
Tübingen, Baden-Wurttemberg, 72076
- Recruiting
Praxis Prof. Kassubek/Prof. Riecker /ID# 274165
Ulm, Baden-Wurttemberg, 89073
- Recruiting
Parkinson-Klinik Ortenau GmbH&Co KG /ID# 274161
Wolfach, Baden-Wurttemberg, 77709
About this study
Official title: German Real-World Evidence Study on the Effectiveness of Foslevodopa/Foscarbidopa at Initial Stages of Advanced Parkinson's Disease: Motor Symptoms, Quality of Life, Psychosocial Functioning and Work Ability
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 German adult participants at initial stages of advanced Parkinson's disease under routine clinical practice.
Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 125 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 20 sites in Germany.
Read more
Participants will receive Foslevodopa/Foscarbidopa 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
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Foscarbidopa/Foslevodopa
- Medical subject headings
- Parkinson Disease
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 |
|---|---|---|
| Foslevodopa/Foscarbidopa | Participants will receive Foslevodopa/Foscarbidopa 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 OFF Time (hours)
The mean change from baseline to each scheduled visit in the number of hours spent in OFF time will be estimated using a mixed-effect model repeated-measures (MMRM).
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start5 May 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- 125 participants (estimated)
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
- NCT06916507
- Sponsor's protocol ID
- P25-278
- Status last verified
- Sep 2026
- First submitted
- 1 Apr 2025
- Last updated
- 2 Oct 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German Real-World Evidence Study on the Effectiveness of Foslevodopa/Foscarbidopa at Initial Stages of Advanced Parkinson's Disease: Motor Symptoms, Quality of Life, Psychosocial Functioning and Work Ability
- ClinicalTrials.gov ID
- NCT06916507
- Acronym / sponsor ID
- P25-278
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Foscarbidopa/Foslevodopa
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 5 May 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 8 Apr 2025 (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 German adult participants at initial stages of advanced Parkinson's disease under routine clinical practice.
Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 125 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 20 sites in Germany.
Participants will receive Foslevodopa/Foscarbidopa 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 |
|---|---|---|
| Foslevodopa/Foscarbidopa | – | –Participants will receive Foslevodopa/Foscarbidopa as prescribed by their physician according to local label. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with advanced Parkinson's disease with time since the beginning of motor fluctuations <= 5 years and the Hoehn and Yahr (H\&Y) stage <= 3 in the on-medication condition treated with foslevodopa/foscarbidopa according to label in Germany
Key inclusion criteria (6 listed)
- Participants with a diagnosis of levodopa-responsive idiopathic Parkinson's disease
- Eligibility for foscarbidopa/foslevodopa (LDp/CDp) therapy in accordance with the approved local label
- Participant must be an adult male or female, 18-67 years of age
- Time since beginning of motor fluctuations <= 5 years
- The Hoehn and Yahr (H\&Y) stage <= 3
Key exclusion criteria (3 listed)
- Previous Exposure to any device-aided therapy (DAT).
- Any condition included in the contraindications section of the approved local LDp/CDp label.
- 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 OFF Time (hours)
Time frame: Up to 6 months
The mean change from baseline to each scheduled visit in the number of hours spent in OFF time will be estimated using a mixed-effect model repeated-measures (MMRM).
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 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
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.
ABBVIE INC. study director
AbbVie
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by AbbVie at 19 sites in Germany.
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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany. 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?
Contact Medical Information Germany (49 611 1720 1520, medinfo.germany@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in OFF Time (hours) (time frame: Up to 6 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 2 Oct 2026.