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Clinical Trials in Spain / NCT07284342
Recruiting Observational

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

NCT07284342 · tracked via the Priya Life Science Spain tracker
Sponsor
AbbVie
Phase
Observational
Started
2025-11-17
Last updated
2026-09-11

Condition(s) studied

Advanced Parkinson's Disease

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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
    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).

Trial sites (16)

FacilityCityRegionStatus
Hospital Regional Universitario de Malaga /ID# 276357 Málaga Andalusia Recruiting
Hospital Universitari Son Espases /ID# 276349 Palma Balearic Islands Recruiting
Hospital Germans Trias i Pujol /ID# 280865 Badalona Barcelona Recruiting
Hospital Universitario Marques de Valdecilla /ID# 276315 Santander Cantabria Recruiting
Hospital General Universitario Santa Lucia /ID# 277222 Cartagena Murcia Recruiting
Hospital de Cabuenes /ID# 276314 Gijón Principality of Asturias Recruiting
Hospital Universitario Virgen del Rocio /ID# 277806 Seville Sevilla Recruiting
Hospital Universitario Torrecardenas /ID# 276899 Almería Spain Recruiting
Hospital Universitario Vall de Hebron /ID# 276318 Barcelona Spain Recruiting
Hospital Santa Creu i Sant Pau /ID# 276319 Barcelona Spain Recruiting
Hospital Universitario De Burgos /ID# 276317 Burgos Spain Recruiting
Hospital De Santa Caterina /ID# 280913 Girona Spain Recruiting
Hospital Universitario Virgen de las Nieves /ID# 276350 Granada Spain Recruiting
Hospital Universitario Clinico San Cecilio /ID# 276356 Granada Spain Recruiting
Complejo Hospitalario Universitario de Pontevedra /ID# 276313 Pontevedra Spain Recruiting
Hospital Universitario De Toledo /ID# 276884 Toledo Spain Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07284342 on ClinicalTrials.gov ↗ ← All trials in Spain