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Recruiting NCT07284342

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

— Observational Advanced Parkinson's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Advanced Parkinson's Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • 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) [Time frame: Up to approximately 12 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 16 centers
  • Hospital Regional Universitario de Malaga /ID# 276357 — Málaga
  • Hospital Universitari Son Espases /ID# 276349 — Palma
  • Hospital Germans Trias i Pujol /ID# 280865 — Badalona
  • Hospital Universitario Marques de Valdecilla /ID# 276315 — Santander
  • Hospital General Universitario Santa Lucia /ID# 277222 — Cartagena
  • Hospital de Cabuenes /ID# 276314 — Gijón
  • Hospital Universitario Virgen del Rocio /ID# 277806 — Seville
  • Hospital Universitario Torrecardenas /ID# 276899 — Almería
  • … and 8 more centers

Identifiers

NCT: NCT07284342 · P25-423

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗