Parkinson's sleep breakthrough? new infusion under study
NCT ID NCT07284342
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times
Summary
This study looks at whether a new pump-delivered medication (Foslevodopa/Foscarbidopa) can help improve sleep problems in people with advanced Parkinson's disease. About 103 adults in Spain will take part, and researchers will track their sleep quality over 12 weeks using a simple questionnaire. The goal is to see if this already-approved treatment makes a real difference in nighttime rest.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 103 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adult participants with advanced Parkinson's disease receiving subcutaneous infusion of Foslevodopa/Foscarbidopa as prescribed by their physician.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
16 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Complejo Hospitalario Universitario de Pontevedra /ID# 276313
RECRUITINGPontevedra, 36071, Spain
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Hospital De Santa Caterina /ID# 280913
RECRUITINGGirona, 17190, Spain
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Hospital General Universitario Santa Lucia /ID# 277222
RECRUITINGCartagena, Murcia, 30202, Spain
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Hospital Germans Trias i Pujol /ID# 280865
RECRUITINGBadalona, Barcelona, 08916, Spain
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Hospital Regional Universitario de Malaga /ID# 276357
RECRUITINGMálaga, Andalusia, 29010, Spain
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Hospital Santa Creu i Sant Pau /ID# 276319
RECRUITINGBarcelona, 08041, Spain
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Hospital Universitari Son Espases /ID# 276349
RECRUITINGPalma, Balearic Islands, 07120, Spain
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Hospital Universitario Clinico San Cecilio /ID# 276356
RECRUITINGGranada, 18016, Spain
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Hospital Universitario De Burgos /ID# 276317
RECRUITINGBurgos, 09006, Spain
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Hospital Universitario De Toledo /ID# 276884
RECRUITINGToledo, 45007, Spain
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Hospital Universitario Marques de Valdecilla /ID# 276315
RECRUITINGSantander, Cantabria, 39008, Spain
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Hospital Universitario Torrecardenas /ID# 276899
RECRUITINGAlmería, 04009, Spain
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Hospital Universitario Vall de Hebron /ID# 276318
RECRUITINGBarcelona, 08035, Spain
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Hospital Universitario Virgen de las Nieves /ID# 276350
RECRUITINGGranada, 18014, Spain
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Hospital Universitario Virgen del Rocio /ID# 277806
RECRUITINGSeville, Sevilla, 41013, Spain
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Hospital de Cabuenes /ID# 276314
RECRUITINGGijón, Principality of Asturias, 33394, Spain
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