Parkinson's DiseaseORCHESTRANCT06937034
Study on Practical ExperienceS of Treatment With Foslevodopa/foScaRbidopa in Advanced Parkinson's Disease
An observational study of Parkinson's Disease, run by AbbVie at 4 sites in 4 countries.
Trial summary
Main objective of this study is to describe the evolution of infusion settings (base, high and low infusion rates) of foslevodopa/foscarbidopa subcutaneous infusion (LDp/CDp) at different timepoints in the treatment of advanced Parkinson's disease (aPD) as captured in ONE-CRM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- How many people
- 2,000 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 14 Apr 2025to Dec 2025
- 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: Advanced Parkinson Disease Patients treated with foslevodopa/foscarbidopa.
Who may be able to join
- Diagnosed with levodopa-responsive idiopathic Parkinson's Disease prescribed on LDp/CDp CSCI in routine clinical practice who have consented to be enrolled in the AbbVie Patient Support Program.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Austria1 site, 1 recruiting
- Not yet recruiting
Medizinische Universitaet Graz /ID# 278569
Graz, Styria, 8010
Netherlands1 site, 1 recruiting
- Recruiting
Medisch Spectrum Twente /ID# 276695
Enschede, Overijssel, 7512 KZ
Romania1 site, 1 recruiting
- Recruiting
Universitatea De Medicină Și Farmacie Victor Babeș /ID# 276720
Timișoara, Timiș County, 300041
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital Solna /ID# 277116
Solna, Stockholm County, 171 64
About this study
Official title: Observational Retrospective CoHort Study on Practical ExperienceS of Treatment With Foslevodopa/foScaRbidopa in Advanced Parkinson's Disease
Main objective of this study is to describe the evolution of infusion settings (base, high and low infusion rates) of foslevodopa/foscarbidopa subcutaneous infusion (LDp/CDp) at different timepoints in the treatment of advanced Parkinson's disease (aPD) as captured in ONE-CRM.
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease
- 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 |
|---|---|---|
| Participants with Parkinson's Disease | Advanced Parkinson Disease Patients treated with foslevodopa/foscarbidopa. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Base Infusion Rate
Mean base infusion rate (ml/hour) will be assessed
Measured: Through end of optimization period (defined as no additional dose modification for at least 15 days since the last dose modification).
Mean Low Infusion Rate
Mean low infusion rate (ml/hour) will be assessed
Measured: Through end of optimization period (defined as no additional dose modification for at least 15 days since the last dose modification).
Mean High Infusion Rate
Mean high infusion rate (ml/hour) will be assessed
Measured: Through end of optimization period (defined as no additional dose modification for at least 15 days since the last dose modification).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start14 Apr 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Retrospective
- Enrolment
- 2,000 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
- NCT06937034
- Sponsor's protocol ID
- H25-878
- Acronym
- ORCHESTRA
- Status last verified
- Aug 2025
- First submitted
- 10 Apr 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Warnecke T, Van der Plas AA, Schwingenschuh P, Johansson A, Simu M, O'Meara M, Gupta R, Fritz B, Bergmann L, Parra JC, Sudmeyer M. Observational Retrospective Cohort of Patient Support Program Data on Practical Experiences of Treatment with Foslevodopa/Foscarbidopa in Advanced Parkinson's Disease: The ORCHESTRA Study. Neurol Ther. 2026 Aug;15(4):2073-2095. doi: 10.1007/s40120-026-00978-0. Epub 2026 Jun 20.
PubMed 42322391
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective CoHort Study on Practical ExperienceS of Treatment With Foslevodopa/foScaRbidopa in Advanced Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06937034
- Acronym / sponsor ID
- ORCHESTRA / H25-878
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 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.
Main objective of this study is to describe the evolution of infusion settings (base, high and low infusion rates) of foslevodopa/foscarbidopa subcutaneous infusion (LDp/CDp) at different timepoints in the treatment of advanced Parkinson's disease (aPD) as captured in ONE-CRM.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Parkinson's Disease | – | –Advanced Parkinson Disease Patients treated with foslevodopa/foscarbidopa. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced Parkinson Disease Patients treated with foslevodopa/foscarbidopa.
Key inclusion criteria (1 listed)
- Diagnosed with levodopa-responsive idiopathic Parkinson's Disease prescribed on LDp/CDp CSCI in routine clinical practice who have consented to be enrolled in the AbbVie Patient Support Program.
Key exclusion criteria (0 listed)
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
Mean Base Infusion Rate
Time frame: Through end of optimization period (defined as no additional dose modification for at least 15 days since the last dose modification).
Mean base infusion rate (ml/hour) will be assessed
Mean Low Infusion Rate
Time frame: Through end of optimization period (defined as no additional dose modification for at least 15 days since the last dose modification).
Mean low infusion rate (ml/hour) will be assessed
Mean High Infusion Rate
Time frame: Through end of optimization period (defined as no additional dose modification for at least 15 days since the last dose modification).
Mean high infusion rate (ml/hour) will be assessed
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 5 Aug 2025.
- Derived from this study: PubMed 42322391Warnecke T, Van der Plas AA, Schwingenschuh P, Johansson A, Simu M, O'Meara M, Gupta R, Fritz B, Bergmann L, Parra JC, Sudmeyer M. Observational Retrospective Cohort of Patient Support Program Data on Practical Experiences of Treatment with Foslevodopa/Foscarbidopa in Advanced Parkinson's Disease: The ORCHESTRA Study. Neurol Ther. 2026 Aug;15(4):2073-2095. doi: 10.1007/s40120-026-00978-0. Epub 2026 Jun 20.
- 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
4 sites in 4 countries: 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 4 sites in 4 countries.
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 1 inclusion and 0 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 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria, Netherlands, Romania, Sweden. 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 ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Base Infusion Rate (time frame: Through end of optimization period (defined as no additional dose modification for at least 15 days since the last dose modification).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06937034, which also lists 1 linked publication.
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 5 Aug 2025.