NCT07284342Recruiting
A Study to Assess Change in Sleep Disturbances of Adult Participants With Advanced Parkinson's Disease Receiving Subcutaneous Foslevodopa/Foscarbidopa
Observational Study Evaluating Subcutaneous LDp/CDp Solution for Infusion Effectiveness on Sleep Disturbances in Advanced Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 103 (estimated)
- First submitted
- 21 Nov 2025
- Start date
- 17 Nov 2025
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- AbbVie
- Diseases
- Parkinson disease
- NCT number
- NCT07284342
What you commit to
- Study type: Observational
- Planned participants: 103
- From 17 Nov 2025 to the primary completion date, 31 Jan 2027
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Torrecardenas /ID# 276899 Coordinator of this site? Confirm its status | Almería | Spain | Recruiting |
| Hospital Germans Trias i Pujol /ID# 280865 Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Universitario Vall de Hebron /ID# 276318 Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Santa Creu i Sant Pau /ID# 276319 Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario De Burgos /ID# 276317 Coordinator of this site? Confirm its status | Burgos | Spain | Recruiting |
| Hospital General Universitario Santa Lucia /ID# 277222 Coordinator of this site? Confirm its status | Cartagena | Spain | Recruiting |
| Hospital de Cabuenes /ID# 276314 Coordinator of this site? Confirm its status | Gijón | Spain | Recruiting |
| Hospital De Santa Caterina /ID# 280913 Coordinator of this site? Confirm its status | Girona | Spain | Recruiting |
| Hospital Universitario Virgen de las Nieves /ID# 276350 Coordinator of this site? Confirm its status | Granada | Spain | Recruiting |
| Hospital Universitario Clinico San Cecilio /ID# 276356 Coordinator of this site? Confirm its status | Granada | Spain | Recruiting |
| Hospital Regional Universitario de Malaga /ID# 276357 Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Universitari Son Espases /ID# 276349 Coordinator of this site? Confirm its status | Palma | Spain | Recruiting |
| Complejo Hospitalario Universitario de Pontevedra /ID# 276313 Coordinator of this site? Confirm its status | Pontevedra | Spain | Recruiting |
| Hospital Universitario Marques de Valdecilla /ID# 276315 Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Hospital Universitario Virgen del Rocio /ID# 277806 Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Hospital Universitario De Toledo /ID# 276884 Coordinator of this site? Confirm its status | Toledo | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.