What is this study trying to find out about advanced Parkinson's disease?

This study is observing how sleep disturbances change in adults with advanced Parkinson's disease who receive subcutaneous Foslevodopa/Foscarbidopa. Researchers want to understand how this treatment affects sleep issues common in Parkinson's disease. The study is sponsored by AbbVie and involves participants receiving routine clinical care.

Who may be eligible for this advanced Parkinson's disease clinical trial?

Adults aged 18 and older with advanced Parkinson's disease responsive to levodopa may be eligible. Participants must have a cognitive score (MMSE) of 24 or higher and be prescribed Foslevodopa/Foscarbidopa infusion by their doctor. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced Parkinson's disease clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses to attend visits may vary and are not guaranteed to be covered. Participants can expect to attend regular visits as part of their usual care.

Actively Recruiting

Age: 18Years +

All Genders

ID07284342

Observational Study Evaluating Subcutaneous FoslevodopaFoscarbidopa Infusion Effectiveness on Sleep Disturbances in Advanced Parkinsons Disease

Led by AbbVie · Updated on 2026-06-04

103

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating changes in sleep disturbances among adults with advanced Parkinsons disease who are receiving subcutaneous FoslevodopaFoscarbidopa. Parkinsons disease affects the brain, causing symptoms like tremors, stiffness, and slow movement. This observational study involves approximately 103 participants prescribed this medication as part of their routine care across multiple sites in Spain. Participants will receive FoslevodopaFoscarbidopa through a subcutaneous infusion as directed by their doctors, following the approved usage guidelines. The study does not involve additional treatments or interventions beyond what is typically prescribed. Participants will be followed for up to 12 weeks while continuing their usual clinical care. During the study, participants will attend regular clinic or hospital visits aligned with their routine care schedule. Researchers will assess changes in sleep disturbances using the Parkinsons Disease Sleep Scale - 2 PDSS-2 over approximately 12 weeks. No extra burdens are expected for participants beyond their standard medical visits, and the study aims to monitor the medications impact on sleep in real-life settings.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 years or older with advanced Parkinson's disease responsive to levodopa and prescribed Foslevodopa/Foscarbidopa subcutaneous infusion following approved guidelines
Mini-Mental State Examination (MMSE) score of 24 or higher
Treatment decision with Foslevodopa/Foscarbidopa infusion made by clinician before study participation
Participants with moderate to severe obstructive sleep apnea eligible if compliant with CPAP or mandibular advancement device treatment and have Apnea-Hypoapnea Index less than 15

You will not qualify if you...

Participants with contraindications to Foslevodopa/Foscarbidopa subcutaneous infusion as per approved guidelines
Participants currently enrolled in interventional research studies at the time of enrollment (excluding non-interventional studies, post marketing observational studies, or registries)

Research Team

AbbVie Spain

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