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Introduction <p>Foslevodopa/foscarbidopa (LDp/CDp) is a nonsurgical 24-h continuous subcutaneous infusion for patients with advanced Parkinson’s disease (aPD) and motor fluctuations uncontrolled on oral medications. We present the first multicountry real-world data from routine clinical practice.</p> Methods <p>ROSSINI (NCT06107426) is an ongoing 3-year multicountry, prospective, observational study of adults with aPD who are LDp/CDp-naïve (cohort A) or transitioning from LDp/CDp open-label extension studies (NCT04379050/NCT04750226, cohort B). For this interim analysis, the primary endpoint was change from baseline to 6&#xa0;months in OFF time [Movement Disorder Society Unified Parkinson’s Disease Rating Scale Part IV (MDS-UPDRS-IV) modified item 4.3]. Safety was assessed by monitoring adverse events (AEs). Interim results for 105 cohort A patients enrolled ≥ 6&#xa0;months by March 24, 2025 are presented only; cohort B results were limited (<i>n</i> = 5). Mixed-effects models for repeated measurements (continuous outcomes) were utilized, adjusted for country.</p> Results <p>Cohort A patients had a mean (SD) age of 68.5 (9.5)&#xa0;years, PD duration of 12.1 (5.3) years, and least squares mean (SE) OFF time of 5.2 (0.6)&#xa0;h at baseline. Patients on LDp/CDp showed statistically significant reductions (95% CI) in OFF time [(− 2.8&#xa0;h (− 3.6, − 1.9), <i>P</i> ≤ .001, <i>n</i> = 47/40 at baseline/month 6], dyskinesia time [− 1.8&#xa0;h (− 2.6, − 0.9), <i>P</i> ≤ 0.001], MDS-UPDRS-III [− 5.0 (− 8.2, − 1.9), <i>P</i> = 0.002], Parkinson’s Disease Sleep Scale-2 [− 5.2 (− 8.0, − 2.4), <i>P</i> ≤ .001], and 39-item Parkinson’s Disease Questionnaire [PDQ-39, − 5.6 (− 9.2, − 2.0), <i>P</i> = .002] from baseline to month&#xa0;6. Freezing of Gait Questionnaire, Gastrointestinal Dysfunction Scale in PD, and King’s PD Pain Scale likewise showed statistically significant decreases (<i>P</i> &lt; .05). Overall, 58 (55.2%) reported ≥ 1 AE, primarily nonserious and mild-to-moderate (12.4% serious, 17.1% severe), with hallucinations and infusion site events the most frequently reported events (5.7% each).</p> Conclusions <p>ROSSINI demonstrates reductions in motor fluctuations and nonmotor symptoms, and increased quality of life in patients with aPD after 6&#xa0;months of LDp/CDp treatment. The safety profile was consistent with clinical trials.</p> Trial registration <p>ClinicalTrials.gov identifier, NCT06107426.</p>

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Real-World Safety and Effectiveness of 24-Hour Foslevodopa/Foscarbidopa in Parkinson's Disease: ROSSINI Study 6-Month Interim Results

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月7日

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  • Wolfgang H. Jost,
  • Filip Bergquist,
  • Andrew Evans,
  • Sharon Hassin-Baer,
  • Robert A. Hauser,
  • Tove Henriksen,
  • Irene A. Malaty,
  • Tiago A. Mestre,
  • Pablo Mir,
  • Ramon Rodriguez,
  • Petra Schwingenschuh,
  • Mihaela Simu,
  • Lars Bergmann,
  • Teresa T. Zhou,
  • Sarah Caughlin,
  • Mallika Gopalkrishnan,
  • Pavnit Kukreja,
  • Marie O’Meara,
  • Juan Carlos Parra,
  • Megha B. Shah,
  • Jason Aldred

摘要

Introduction

Foslevodopa/foscarbidopa (LDp/CDp) is a nonsurgical 24-h continuous subcutaneous infusion for patients with advanced Parkinson’s disease (aPD) and motor fluctuations uncontrolled on oral medications. We present the first multicountry real-world data from routine clinical practice.

Methods

ROSSINI (NCT06107426) is an ongoing 3-year multicountry, prospective, observational study of adults with aPD who are LDp/CDp-naïve (cohort A) or transitioning from LDp/CDp open-label extension studies (NCT04379050/NCT04750226, cohort B). For this interim analysis, the primary endpoint was change from baseline to 6 months in OFF time [Movement Disorder Society Unified Parkinson’s Disease Rating Scale Part IV (MDS-UPDRS-IV) modified item 4.3]. Safety was assessed by monitoring adverse events (AEs). Interim results for 105 cohort A patients enrolled ≥ 6 months by March 24, 2025 are presented only; cohort B results were limited (n = 5). Mixed-effects models for repeated measurements (continuous outcomes) were utilized, adjusted for country.

Results

Cohort A patients had a mean (SD) age of 68.5 (9.5) years, PD duration of 12.1 (5.3) years, and least squares mean (SE) OFF time of 5.2 (0.6) h at baseline. Patients on LDp/CDp showed statistically significant reductions (95% CI) in OFF time [(− 2.8 h (− 3.6, − 1.9), P ≤ .001, n = 47/40 at baseline/month 6], dyskinesia time [− 1.8 h (− 2.6, − 0.9), P ≤ 0.001], MDS-UPDRS-III [− 5.0 (− 8.2, − 1.9), P = 0.002], Parkinson’s Disease Sleep Scale-2 [− 5.2 (− 8.0, − 2.4), P ≤ .001], and 39-item Parkinson’s Disease Questionnaire [PDQ-39, − 5.6 (− 9.2, − 2.0), P = .002] from baseline to month 6. Freezing of Gait Questionnaire, Gastrointestinal Dysfunction Scale in PD, and King’s PD Pain Scale likewise showed statistically significant decreases (P < .05). Overall, 58 (55.2%) reported ≥ 1 AE, primarily nonserious and mild-to-moderate (12.4% serious, 17.1% severe), with hallucinations and infusion site events the most frequently reported events (5.7% each).

Conclusions

ROSSINI demonstrates reductions in motor fluctuations and nonmotor symptoms, and increased quality of life in patients with aPD after 6 months of LDp/CDp treatment. The safety profile was consistent with clinical trials.

Trial registration

ClinicalTrials.gov identifier, NCT06107426.