Advanced Parkinson's DiseaseONIROSNCT07284342
A Study to Assess Change in Sleep Disturbances of Adult Participants With Advanced Parkinson's Disease Receiving Subcutaneous Foslevodopa/Foscarbidopa
An observational study of Advanced Parkinson's Disease, run by AbbVie at 16 sites in Spain.
Trial summary
Parkinson's disease (PD) is a neurological condition, which affects the brain. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess change in sleep disturbances of adult participants with advanced Parkinson's disease receiving subcutaneous Foslevodopa/Foscarbidopa under routine… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Parkinson's Disease
- How many people
- 103 participants
- Where
- 16 sitesSpain
- Study dates
- 17 Nov 2025to Jan 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: Adult participants with advanced Parkinson's disease receiving subcutaneous infusion of Foslevodopa/Foscarbidopa as prescribed by their physician.
Who may be able to join
- Adult (age >=18 years) Advance Parkinson's Disease (aPD) participants, diagnosed of levodopa-responsive idiopathic Symptoms PD (PD) prescribed on foslevodopa/foscarbidopa (LDp/CDp) Subcutaneous solution for infusion (SI) in routine clinical practice following approved Summary of product characteristics (SmPC) (levodopa-responsive Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results).
- MMSE>=24 (cognitive cut point for the subjects to be able to comply with study procedures).
- Decision to treat with LDp/CDp SI made by the clinician prior to any decision to approach the subject to participate in this study.
- Particpants with moderate to severe obstructive sleep apnea (OSA) (Apnea-Hypoapnea Index (AHI)>15) may be eligible if they comply with treatment (Continuous Positive Airway Pressure (CPAP) device used at least 4 hours/night and 70% of the nights during last month or mandibular advancement device (MAD)) and have an AHI <15.
Who cannot join
- Participants presenting with contraindications as per LDp/CDp SI SmPC. 2.
- Participants participating in interventional research (not including non-interventional study, Post Marketing Observational Studies (PMOS), or registry participation) at time of enrollment visit.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
Spain16 sites, 16 recruiting
- Recruiting
Hospital Universitario Torrecardenas /ID# 276899
Almería, 04009
- Recruiting
Hospital Germans Trias i Pujol /ID# 280865
Badalona, Barcelona, 08916
- Recruiting
Hospital Universitario Vall de Hebron /ID# 276318
Barcelona, 08035
- Recruiting
Hospital Santa Creu i Sant Pau /ID# 276319
Barcelona, 08041
- Recruiting
Hospital Universitario De Burgos /ID# 276317
Burgos, 09006
- Recruiting
Hospital General Universitario Santa Lucia /ID# 277222
Cartagena, Murcia, 30202
- Recruiting
Hospital de Cabuenes /ID# 276314
Gijón, Principality of Asturias, 33394
- Recruiting
Hospital De Santa Caterina /ID# 280913
Girona, 17190
- Recruiting
Hospital Universitario Virgen de las Nieves /ID# 276350
Granada, 18014
- Recruiting
Hospital Universitario Clinico San Cecilio /ID# 276356
Granada, 18016
- Recruiting
Hospital Regional Universitario de Malaga /ID# 276357
Málaga, Andalusia, 29010
- Recruiting
Hospital Universitari Son Espases /ID# 276349
Palma, Balearic Islands, 07120
- Recruiting
Complejo Hospitalario Universitario de Pontevedra /ID# 276313
Pontevedra, 36071
- Recruiting
Hospital Universitario Marques de Valdecilla /ID# 276315
Santander, Cantabria, 39008
- Recruiting
Hospital Universitario Virgen del Rocio /ID# 277806
Seville, Sevilla, 41013
- Recruiting
Hospital Universitario De Toledo /ID# 276884
Toledo, 45007
About this study
Official title: Observational Study Evaluating Subcutaneous LDp/CDp Solution for Infusion Effectiveness on Sleep Disturbances in Advanced Parkinson's Disease
Parkinson's disease (PD) is a neurological condition, which affects the brain. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess change in sleep disturbances of adult participants with advanced Parkinson's disease receiving subcutaneous Foslevodopa/Foscarbidopa under routine clinical practice.
Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 103 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 20 sites across Spain.
Read more
Participants will receive Foslevodopa/Foscarbidopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 12 weekss.
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's Disease
- Keywords
- Advanced Parkinson's Disease, Foslevodopa/Foscarbidopa
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 on Parkinson's Disease (PD)-related sleep disturbances in Advance Parkinson's Disease (aPD) Participants, as assessed by the Parkinson's Disease Sleep Scale - 2 (PDSS-2)
The Parkinson's Disease Sleep Scale (PDSS-2) is a self-administered questionnaire and consists of 15 questions on sleep and nocturnal disturbances which can be related to PD. Participants rate each question using a frequency score, ranging from 0 (never) to 4 (very often), the PDSS-2 total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance).
Measured: Up to approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start17 Nov 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 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'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
- 103 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
- NCT07284342
- Sponsor's protocol ID
- P25-423
- Acronym
- ONIROS
- Status last verified
- Sep 2026
- First submitted
- 21 Nov 2025
- Last updated
- 11 Sep 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Evaluating Subcutaneous LDp/CDp Solution for Infusion Effectiveness on Sleep Disturbances in Advanced Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07284342
- Acronym / sponsor ID
- ONIROS / P25-423
- Conditions
- Advanced Parkinson's Disease
- Keywords
- Advanced Parkinson's Disease, Foslevodopa/Foscarbidopa
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 16 Dec 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. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess change in sleep disturbances of adult participants with advanced Parkinson's disease receiving subcutaneous Foslevodopa/Foscarbidopa under routine clinical practice.
Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 103 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 20 sites across Spain.
Participants will receive Foslevodopa/Foscarbidopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 12 weekss.
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
- Adult participants with advanced Parkinson's disease receiving subcutaneous infusion of Foslevodopa/Foscarbidopa as prescribed by their physician.
Key inclusion criteria (4 listed)
- Adult (age >=18 years) Advance Parkinson's Disease (aPD) participants, diagnosed of levodopa-responsive idiopathic Symptoms PD (PD) prescribed on foslevodopa/foscarbidopa (LDp/CDp) Subcutaneous solution for infusion (SI) in routine clinical practice following approved Summary of product characteristics (SmPC) (levodopa-responsive Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results).
- MMSE>=24 (cognitive cut point for the subjects to be able to comply with study procedures).
- Decision to treat with LDp/CDp SI made by the clinician prior to any decision to approach the subject to participate in this study.
- Particpants with moderate to severe obstructive sleep apnea (OSA) (Apnea-Hypoapnea Index (AHI)>15) may be eligible if they comply with treatment (Continuous Positive Airway Pressure (CPAP) device used at least 4 hours/night and 70% of the nights during last month or mandibular advancement device (MAD)) and have an AHI <15.
Key exclusion criteria (2 listed)
- Participants presenting with contraindications as per LDp/CDp SI SmPC. 2.
- Participants participating in interventional research (not including non-interventional study, Post Marketing Observational Studies (PMOS), or registry participation) at time of enrollment visit.
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 on Parkinson's Disease (PD)-related sleep disturbances in Advance Parkinson's Disease (aPD) Participants, as assessed by the Parkinson's Disease Sleep Scale - 2 (PDSS-2)
Time frame: Up to approximately 12 weeks
The Parkinson's Disease Sleep Scale (PDSS-2) is a self-administered questionnaire and consists of 15 questions on sleep and nocturnal disturbances which can be related to PD. Participants rate each question using a frequency score, ranging from 0 (never) to 4 (very often), the PDSS-2 total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance).
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 11 Sep 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
16 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's Disease, run by AbbVie at 16 sites in Spain.
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 4 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain. 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 Spain (+34913840910, estudios.spain@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 on Parkinson's Disease (PD)-related sleep disturbances in Advance Parkinson's Disease (aPD) Participants, as assessed by the Parkinson's Disease Sleep Scale - 2 (PDSS-2) (time frame: Up to approximately 12 weeks). 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 11 Sep 2026.