RecruitingNCT07284342

A Study to Assess Change in Sleep Disturbances of Adult Participants With Advanced Parkinson's Disease Receiving Subcutaneous Foslevodopa/Foscarbidopa

Observational Study Evaluating Subcutaneous LDp/CDp Solution for Infusion Effectiveness on Sleep Disturbances in Advanced Parkinson's Disease


Sponsor

AbbVie

Enrollment

103 participants

Start Date

Nov 17, 2025

Study Type

OBSERVATIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study is tracking how sleep problems change in people with advanced Parkinson's disease who are starting a new continuous under-the-skin infusion treatment called foslevodopa/foscarbidopa — a 24-hour medication delivery system to manage motor symptoms. **You may be eligible if...** - You are 18 or older with advanced Parkinson's disease - Your doctor has already decided (independently of this study) to prescribe you foslevodopa/foscarbidopa infusion as part of routine care - Your Parkinson's has severe motor fluctuations (unpredictable on/off periods) and/or involuntary movements that have not been adequately controlled by oral medications - Your cognitive score (MMSE) is 24 or higher - You have moderate-to-severe sleep problems **You may NOT be eligible if...** - You are not already being prescribed foslevodopa/foscarbidopa as part of your standard care - Your cognitive score is below 24 - You do not have significant sleep disturbances Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(14)

Hospital Regional Universitario de Malaga /ID# 276357

Málaga, Andalusia, Spain

Hospital Universitari Son Espases /ID# 276349

Palma, Balearic Islands, Spain

Hospital Universitario Marques de Valdecilla /ID# 276315

Santander, Cantabria, Spain

Hospital General Universitario Santa Lucía /ID# 277222

Cartagena, Murcia, Spain

Hospital de Cabuenes /ID# 276314

Gijón, Principality of Asturias, Spain

Hospital Universitario Virgen del Rocio /ID# 277806

Seville, Sevilla, Spain

Hospital Universitario Torrecárdenas /ID# 276899

Almería, Spain

Hospital Universitario Vall de Hebron /ID# 276318

Barcelona, Spain

Hospital Santa Creu i Sant Pau /ID# 276319

Barcelona, Spain

Hospital Universitario De Burgos /ID# 276317

Burgos, Spain

Hospital Universitario Virgen de las Nieves /ID# 276350

Granada, Spain

Hospital Universitario Clinico San Cecilio /ID# 276356

Granada, Spain

Complejo Hospitalario Universitario de Pontevedra /ID# 276313

Pontevedra, Spain

Hospital Universitario De Toledo /ID# 276884

Toledo, Spain

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NCT07284342


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