Sleep problems in advanced Parkinson's disease during foslevodopa/foscarbidopa infusion treatment
Follows sleep changes in adults with advanced Parkinson's disease receiving foslevodopa/foscarbidopa.
Plain-language title generated from the registry record
Registry title: A Study to Assess Change in Sleep Disturbances of Adult Participants With Advanced Parkinson's Disease Receiving Subcutaneous Foslevodopa/Foscarbidopa
Key facts
- Where
- Almería, Badalona, Barcelona, Burgos, Cartagena, Gijón, Girona, Granada, Málaga, Palma, Pontevedra, Santander, Seville, and Toledo, SpainSee the 16 sites
Where in Spain
- Hospital Universitario Torrecardenas /ID# 276899Almería, SpainTaking people
- Hospital Germans Trias i Pujol /ID# 280865Badalona, SpainTaking people
- Hospital Santa Creu i Sant Pau /ID# 276319Barcelona, SpainTaking people
- Hospital Universitario Vall de Hebron /ID# 276318Barcelona, SpainTaking people
- Hospital Universitario De Burgos /ID# 276317Burgos, SpainTaking people
- Hospital General Universitario Santa Lucia /ID# 277222Cartagena, SpainTaking people
- Hospital de Cabuenes /ID# 276314Gijón, SpainTaking people
- Hospital De Santa Caterina /ID# 280913Girona, SpainTaking people
- Hospital Universitario Clinico San Cecilio /ID# 276356Granada, SpainTaking people
- Hospital Universitario Virgen de las Nieves /ID# 276350Granada, SpainTaking people
- Hospital Regional Universitario de Malaga /ID# 276357Málaga, SpainTaking people
- Hospital Universitari Son Espases /ID# 276349Palma, SpainTaking people
- Complejo Hospitalario Universitario de Pontevedra /ID# 276313Pontevedra, SpainTaking people
- Hospital Universitario Marques de Valdecilla /ID# 276315Santander, SpainTaking people
- Hospital Universitario Virgen del Rocio /ID# 277806Seville, SpainTaking people
- Hospital Universitario De Toledo /ID# 276884Toledo, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AbbVie
- Trial code
- NCT07284342
- Record updated
- 11 September 2026
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: 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: 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.