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

NCT07284342 · AbbVie
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Official title
Observational Study Evaluating Subcutaneous LDp/CDp Solution for Infusion Effectiveness on Sleep Disturbances in Advanced Parkinson's Disease
About this study
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 criteria
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.
Study design
Enrollment target: 103 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-11-17
Estimated completion: 2027-01
Last updated: 2026-07-07
Primary outcomes
  • 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) (Up to approximately 12 weeks)
Sponsor
AbbVie · industry
Contacts & investigators
ContactAbbVie Spain · contact · estudios.spain@abbvie.com · +34913840910
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (16)
Hospital Regional Universitario de Malaga /ID# 276357Recruiting
Málaga, Andalusia, Spain
Hospital Universitari Son Espases /ID# 276349Recruiting
Palma, Balearic Islands, Spain
Hospital Germans Trias i Pujol /ID# 280865Recruiting
Badalona, Barcelona, Spain
Hospital Universitario Marques de Valdecilla /ID# 276315Recruiting
Santander, Cantabria, Spain
Hospital General Universitario Santa Lucía /ID# 277222Recruiting
Cartagena, Murcia, Spain
Hospital de Cabuenes /ID# 276314Recruiting
Gijón, Principality of Asturias, Spain
Hospital Universitario Virgen del Rocio /ID# 277806Recruiting
Seville, Sevilla, Spain
Hospital Universitario Torrecárdenas /ID# 276899Recruiting
Almería, Spain
Hospital Universitario Vall de Hebron /ID# 276318Recruiting
Barcelona, Spain
Hospital Santa Creu i Sant Pau /ID# 276319Recruiting
Barcelona, Spain
Hospital Universitario De Burgos /ID# 276317Recruiting
Burgos, Spain
Hospital De Santa Caterina /ID# 280913Recruiting
Girona, Spain
Hospital Universitario Virgen de las Nieves /ID# 276350Recruiting
Granada, Spain
Hospital Universitario Clinico San Cecilio /ID# 276356Recruiting
Granada, Spain
Complejo Hospitalario Universitario de Pontevedra /ID# 276313Recruiting
Pontevedra, Spain
Hospital Universitario De Toledo /ID# 276884Recruiting
Toledo, Spain
A Study to Assess Change in Sleep Disturbances of Adult Participants With Advanced Parkinson's Disease Receiving Subcutaneous Foslevodopa/Foscarbidopa · TrialPath