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PUCCININCT07227896

Real-World Study of Foslevodopa/Foscarbidopa to Assess Quality of Life Outcomes in Adult Participants Earlier Within Advanced Parkinson Disease

StatusRecruiting
PhaseNot specified
SponsorAbbVie
Primary completion (estimated)

At risk: Primary endpoint(s) modified.

See at-risk trials from AbbVie

Track this trial

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified
    • Eligibility criteria expanded, about 20 words
    • Trial sites expanded: 10 → 26 locations
    • Secondary endpoints revised (11)
  2. Recruitment opened
    • Start date changed from estimate of Mar 1, 2026 to Aug 3, 2026
    • Trial sites expanded: 1 → 10 locations
    v3
  3. Start date: Nov 24, 2025 to Mar 1, 2026v2
  4. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Change From Baseline in motor complications as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV subscore
Timeframe: Up to approximately 6 months

Secondary (11)

Change From Baseline to "Off" Time Duration (absolute hours) and Severity, as measured by the modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV, Item 4.3 and 4.4 scores
Change From Baseline in Dyskinesia presence, impairment and disability, as measured by Unified Dyskinesia Rating Scale (UDysRS) total score
Change From Baseline in Dyskinesia duration (absolute hours) and severity, as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV, Item 4.1 and 4.2 score
Change From Baseline in Disease-specific Quality of Life (QoL) as measured by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index
Change From Baseline in Generic Quality of Life (QoL) as measured by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L)
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Change From Baseline in Motor experiences of daily living as measured by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Change From Baseline in Disease-specific sleep disturbances as measured by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score
Change From Baseline in Symptom severity measured by the Patient Global Impression of Severity (PGI-S) questionnaire.
Change From Baseline in Clinician-Reported Symptom Severity measured by the Clinical Global Impression of Severity (CGI-S) questionnaire.
Change From Baseline in Patient-Reported Symptom Change measured by the Patient Global Impression of Change (PGI-C) questionnaire
Change From Baseline in Clinician-Reported Symptom Change measured by the Clinical Global Impression of Change (CGI-C) questionnaire.

Arms and interventions

Foslevodopa/Foscarbidopa

Participants will receive Foslevodopa/Foscarbidopa as prescribed by their physician according to local label.

Sites

26 sites in 9 countries

Japan 5, Israel 4, Romania 4, United States 4, United Kingdom 3, Canada 2, Croatia 2, Puerto Rico 1, Spain 1