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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• Participants 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.

Locations
Other Locations
Spain
Hospital Universitario Virgen de las Nieves /ID# 276350
RECRUITING
Granada
Hospital Regional Universitario de Malaga /ID# 276357
RECRUITING
Málaga
Contact Information
Primary
AbbVie Spain
estudios.spain@abbvie.com
+34913840910
Time Frame
Start Date: 2025-11-17
Estimated Completion Date: 2026-03
Participants
Target number of participants: 103
Treatments
Foslevodopa/Foscarbidopa
Participants will receive Foslevodopa/Foscarbidopa as prescribed by their physician according to local label.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov