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

Recruiting now

Conditions studied: Advanced Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT07284342

Run by

AbbVie

People needed

103

Starts

2025-11-17

Expected to finish

2027-01-01

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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