A Study to Assess Change in Sleep Disturbances of Adult Participants With Advanced Parkinson's Disease Receiving Subcutaneous Foslevodopa/Foscarbidopa
NCT ID: NCT07284342
Last Updated: 2026-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
103 participants
OBSERVATIONAL
2025-11-17
2027-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Foslevodopa/Foscarbidopa
Participants will receive Foslevodopa/Foscarbidopa as prescribed by their physician according to local label.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 participating in interventional research (not including non-interventional study, Post Marketing Observational Studies (PMOS), or registry participation) at time of enrollment visit.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Hospital Regional Universitario de Malaga /ID# 276357
Málaga, Andalusia, Spain
Hospital Universitario Marques de Valdecilla /ID# 276315
Santander, Cantabria, Spain
Hospital General Universitario Santa Lucía /ID# 277222
Cartagena, Murcia, Spain
Hospital de Cabueñes /ID# 276314
Gijón, Principality of Asturias, Spain
Hospital Universitario Virgen del Rocio /ID# 277806
Seville, Sevilla, Spain
Hospital Universitario Torrecárdenas /ID# 276899
Almería, , Spain
Hospital Universitario Vall de Hebron /ID# 276318
Barcelona, , Spain
Hospital Santa Creu i Sant Pau /ID# 276319
Barcelona, , Spain
Hospital Universitario De Burgos /ID# 276317
Burgos, , Spain
Hospital Universitario Virgen de las Nieves /ID# 276350
Granada, , Spain
Hospital Universitario Clinico San Cecilio /ID# 276356
Granada, , Spain
Complejo Hospitalario Universitario de Pontevedra /ID# 276313
Pontevedra, , Spain
Hospital Universitario De Toledo /ID# 276884
Toledo, , Spain
Countries
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Central Contacts
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Related Links
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Other Identifiers
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P25-423
Identifier Type: -
Identifier Source: org_study_id
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