Parkinson DiseaseFREELIFENCT06965374
Real-World Study of Foslevodopa/Foscarbidopa to Assess Quality of Life Outcomes in Adult Participants With Advanced Parkinson Disease
An observational study of Parkinson Disease, run by AbbVie at 19 sites in Italy.
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
- Parkinson Disease
- How many people
- 270 participants
- Where
- 19 sitesItaly
- Study dates
- 4 Jun 2025to Jun 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 Foslevodopa/Foscarbidopa according to label in Italy
Who may be able to join
- Participants with a diagnosis of levodopa-responsive advance Parkinson's disease (PD)
- Investigator decision on participant treatment with subcutaneous Foslevodopa/Foscarbidopa (LDp/CDp) made prior to, and independently, the decision to approach the participant to participate in the study
- 24-h subcutaneous LDp/CDp treatment prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies
Who cannot join
- Any condition included in the contraindications section of the approved local subcutaneous LDp/CDp label
- Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days. Participation in another Post-Marketing Observational Study (PMOS) or Registry is acceptable
- History of relevant skin conditions or disorders (e.g., psoriasis, atopic dermatitis) per investigator´s judgment. In case of temporary affections like recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations, the subject should not be included if the investigator considers these as interfering with the infusion of study drug or with study assessments
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
Italy19 sites, 19 recruiting
- Recruiting
Azienda Ospedaliero Universitaria delle Marche /ID# 272694
Ancona, 60020
- Recruiting
Ospedale Bellaria - Azienda Usl Di Bologna /ID# 274463
Bologna, 40139
- Recruiting
IRCCS Centro Neurolesi Bonino Pulejo /ID# 273628
Messina, 98124
- Recruiting
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 272949
Milan, Milano, 20122
- Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 273225
Milan, Milano, 20133
- Recruiting
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273434
Naples, Napoli, 80138
- Recruiting
Azienda Ospedale-Universita Padova /ID# 274317
Padova, 35128
- Recruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 272863
Palermo, 90127
- Recruiting
Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 274226
Pavia, 27100
- Recruiting
Azienda Ospedaliero Universitaria Pisana /ID# 273541
Pisa, 56126
- Recruiting
Istituto Neurologico Mediterraneo Neuromed S.P.A. - Irccs /Id# 272695
Pozzilli, Isernia, 86077
- Recruiting
AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 274388
Reggio Emilia, 42122
- Recruiting
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 272834
Rome, Roma, 00133
- Recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 273562
Rome, Roma, 00161
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274539
Rome, Roma, 00168
- Recruiting
AOU San Giovanni di Dio Ruggi d'Aragona - Scuola Medica Salernitana /ID# 274319
Salerno, 84131
- Recruiting
IRCCS Oasi SS. Troina /ID# 273507
Troina, Enna, 94018
- Recruiting
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 273276
Turin, Piedmont, 10126
- Recruiting
Azienda Ulss 3 Serenissima /ID# 273027
Venice, Venezia, 30100
About this study
Official title: Foslevodopa/Foscarbidopa REal-world Evidence in Parkinson's Disease Quality of LIFE Outcomes
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 Foslevodopa/Foscarbidopa is in treating Italian adult participants with advanced Parkinson disease under routine clinical practice. This study will also assess the caregiver quality of life (QOL) (if caregiver is present).
Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 270 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 19 sites in Italy.
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 Disease
- Keywords
- Parkinson Disease, Foslevodopa/Foscarbidopa
- 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 Quality of Life as Measured by PD Questionnaire-39 (PDQ-39) Summary Index
The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in PD. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The total score is between 0 and 156, calculated as the total sum of the items, and higher scores are associated with more severe symptoms. Negative changes from baseline indicate improvement.
Measured: Up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start4 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 270 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
- NCT06965374
- Sponsor's protocol ID
- P25-246
- Acronym
- FREELIFE
- Status last verified
- May 2026
- First submitted
- 2 May 2025
- Last updated
- 13 May 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foslevodopa/Foscarbidopa REal-world Evidence in Parkinson's Disease Quality of LIFE Outcomes
- ClinicalTrials.gov ID
- NCT06965374
- Acronym / sponsor ID
- FREELIFE / P25-246
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Foslevodopa/Foscarbidopa
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 May 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 Foslevodopa/Foscarbidopa is in treating Italian adult participants with advanced Parkinson disease under routine clinical practice. This study will also assess the caregiver quality of life (QOL) (if caregiver is present).
Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 270 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 19 sites in Italy.
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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with advanced Parkinson disease treated with Foslevodopa/Foscarbidopa according to label in Italy
Key inclusion criteria (3 listed)
- Participants with a diagnosis of levodopa-responsive advance Parkinson's disease (PD)
- Investigator decision on participant treatment with subcutaneous Foslevodopa/Foscarbidopa (LDp/CDp) made prior to, and independently, the decision to approach the participant to participate in the study
- 24-h subcutaneous LDp/CDp treatment prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies
Key exclusion criteria (3 listed)
- Any condition included in the contraindications section of the approved local subcutaneous LDp/CDp label
- Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days. Participation in another Post-Marketing Observational Study (PMOS) or Registry is acceptable
- History of relevant skin conditions or disorders (e.g., psoriasis, atopic dermatitis) per investigator´s judgment. In case of temporary affections like recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations, the subject should not be included if the investigator considers these as interfering with the infusion of study drug or with study assessments
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 Quality of Life as Measured by PD Questionnaire-39 (PDQ-39) Summary Index
Time frame: Up to approximately 6 months
The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in PD. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The total score is between 0 and 156, calculated as the total sum of the items, and higher scores are associated with more severe symptoms. Negative changes from baseline indicate improvement.
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 13 May 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.
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 Disease, run by AbbVie at 19 sites in Italy.
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 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 13 May 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 Italy. 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 Caterina Golotta (+39 06 548891, caterina.golotta@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 Quality of Life as Measured by PD Questionnaire-39 (PDQ-39) Summary Index (time frame: Up to approximately 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 13 May 2026.