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Following sleep changes during Parkinson’s treatment

Researchers assess sleep problems in people with advanced Parkinson’s receiving foslevodopa and foscarbidopa through the skin.

Learning by observing or collecting information · Study reference: NCT07284342

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

Open the official registry record ↗

Who can join?

Age 18 years and over · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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.
Full study name & original research details

Official study title

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

Short title used by the registry

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

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. 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.

Conditions reported: Advanced Parkinson's Disease

Study type
Observational
Interventions
Not reported
Phases
Not reported
Sponsor
AbbVie
Start date reported by registry
2025-11-17 (actual)

Registry updated: 2026-09-11 · Status last verified by the registry submitter: 2026-09

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

AbbVie Spain · +34913840910 · estudios.spain@abbvie.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Hospital Regional Universitario de Malaga /ID# 276357

Málaga, Andalusia, Spain

Recruiting

Hospital Universitari Son Espases /ID# 276349

Palma, Balearic Islands, Spain

Recruiting

Hospital Germans Trias i Pujol /ID# 280865

Badalona, Barcelona, Spain

Recruiting

Hospital Universitario Marques de Valdecilla /ID# 276315

Santander, Cantabria, Spain

Recruiting

Hospital General Universitario Santa Lucia /ID# 277222

Cartagena, Murcia, Spain

Recruiting

Hospital de Cabuenes /ID# 276314

Gijón, Principality of Asturias, Spain

Recruiting

Hospital Universitario Virgen del Rocio /ID# 277806

Seville, Sevilla, Spain

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

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.