Study on Practical ExperienceS of Treatment With Foslevodopa/foScaRbidopa in Advanced Parkinson's Disease

NCT06937034 | Recruiting

• 1 other identifier: H25-878
• Study Type: observational
• Target: 2,000
• Locations: 4 countries
• Sites: 4

Brief Summary

Main objective of this study is to describe the evolution of infusion settings (base, high and low infusion rates) of foslevodopa/foscarbidopa subcutaneous infusion (LDp/CDp) at different timepoints in the treatment of advanced Parkinson's disease (aPD) as captured in ONE-CRM.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease

Outcome Measures

Primary Outcomes (3)

• Mean Base Infusion Rate

  Mean base infusion rate (ml/hour) will be assessed

  Through end of optimization period (defined as no additional dose modification for at least 15 days since the last dose modification).

• Mean Low Infusion Rate

  Mean low infusion rate (ml/hour) will be assessed

  Through end of optimization period (defined as no additional dose modification for at least 15 days since the last dose modification).

• Mean High Infusion Rate

  Mean high infusion rate (ml/hour) will be assessed

  Through end of optimization period (defined as no additional dose modification for at least 15 days since the last dose modification).

Study Arms (1)

Participants with Parkinson's Disease

Advanced Parkinson Disease Patients treated with foslevodopa/foscarbidopa.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced Parkinson Disease Patients treated with foslevodopa/foscarbidopa.

You may qualify if:

• \- Diagnosed with levodopa-responsive idiopathic Parkinson's Disease prescribed on LDp/CDp CSCI in routine clinical practice who have consented to be enrolled in the AbbVie Patient Support Program.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (4)

Medizinische Universitaet Graz /ID# 278569

Graz, Styria, 8010, Austria

NOT YET RECRUITING

Medisch Spectrum Twente /ID# 276695

Enschede, Overijssel, 7512 KZ, Netherlands

RECRUITING

Universitatea De Medicină Și Farmacie Victor Babeș /ID# 276720

Timișoara, Timiș County, 300041, Romania

RECRUITING

Karolinska University Hospital Solna /ID# 277116

Solna, Stockholm County, 171 64, Sweden

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 20, 2025
• Study Start: April 14, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-08

Locations

RO (1); AU (1); NL (1); SE (1)