Actively Recruiting
A Study to Assess Change in Sleep Disturbances of Adult Participants With Advanced Parkinson's Disease Receiving Subcutaneous Foslevodopa/Foscarbidopa
Led by AbbVie · Updated on 2026-04-13
103
Participants Needed
14
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Assess Change in Sleep Disturbances of Adult Participants With Advanced Parkinson's Disease Receiving Subcutaneous Foslevodopa/Foscarbidopa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with advanced Parkinson's disease diagnosed as levodopa-responsive idiopathic PD
- Prescribed Foslevodopa/Foscarbidopa subcutaneous infusion in routine clinical practice following approved product guidelines
- Mini-Mental State Examination score of 24 or higher to ensure ability to follow study procedures
- Decision to treat with Foslevodopa/Foscarbidopa subcutaneous infusion made by clinician before study enrollment
- Participants with moderate to severe obstructive sleep apnea may participate if they use CPAP at least 4 hours/night for 70% of nights in the last month or use a mandibular advancement device and have an Apnea-Hypopnea Index below 15
You will not qualify if you...
- Participants with contraindications to Foslevodopa/Foscarbidopa subcutaneous infusion as per approved product guidelines
- Participants currently enrolled in interventional research studies (excluding non-interventional studies, post-marketing observational studies, or registries) at enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Hospital Regional Universitario de Malaga /ID# 276357
Málaga, Andalusia, Spain, 29010
Actively Recruiting
2
Hospital Universitari Son Espases /ID# 276349
Palma, Balearic Islands, Spain, 07120
Actively Recruiting
3
Hospital Universitario Marques de Valdecilla /ID# 276315
Santander, Cantabria, Spain, 39008
Actively Recruiting
4
Hospital General Universitario Santa Lucía /ID# 277222
Cartagena, Murcia, Spain, 30202
Actively Recruiting
5
Hospital de Cabuenes /ID# 276314
Gijón, Principality of Asturias, Spain, 33394
Actively Recruiting
6
Hospital Universitario Virgen del Rocio /ID# 277806
Seville, Sevilla, Spain, 41013
Actively Recruiting
7
Hospital Universitario Torrecárdenas /ID# 276899
Almería, Spain, 04009
Actively Recruiting
8
Hospital Universitario Vall de Hebron /ID# 276318
Barcelona, Spain, 08035
Actively Recruiting
9
Hospital Santa Creu i Sant Pau /ID# 276319
Barcelona, Spain, 08041
Actively Recruiting
10
Hospital Universitario De Burgos /ID# 276317
Burgos, Spain, 09006
Actively Recruiting
11
Hospital Universitario Virgen de las Nieves /ID# 276350
Granada, Spain, 18014
Actively Recruiting
12
Hospital Universitario Clinico San Cecilio /ID# 276356
Granada, Spain, 18016
Actively Recruiting
13
Complejo Hospitalario Universitario de Pontevedra /ID# 276313
Pontevedra, Spain, 36071
Actively Recruiting
14
Hospital Universitario De Toledo /ID# 276884
Toledo, Spain, 45007
Actively Recruiting
Research Team
A
AbbVie Spain
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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