2026 American Academy of Neurology Abstract Website

Jason Aldred¹, Wolfgang Jost², Filip Bergquist³, Andrew Evans⁴, Sharon Hassin-Baer⁵, Robert Hauser⁶, Tove Henriksen⁷, Irene Malaty⁸, Tiago Mestre⁹, Ramon Rodriguez Cruz¹⁰, Petra Schwingenschuh¹¹, Mihaela Simu¹², Lars Bergmann¹³, Sarah Caughlin¹³, Mallika Gopalkrishnan¹³, Pavnit Kukreja¹³, Marie O’Meara¹³, Juan Carlos Parra¹³, Megha Shah¹³, Pablo Mir¹⁴
¹Selkirk Neurology & Inland Northwest Research, ²Parkinson-Klinik Ortenau, ³Department of Clinical Neuroscience Pharmacology, Institute of Neuroscience and Physiology, University of Gothenburg, ⁴The Royal Melbourne Hospital, ⁵Chaim Sheba Medical Center, ⁶University of South Florida, ⁷Movement Disorder Clinic, University Hospital of Bispebjerg, ⁸University of Florida, ⁹Department of Medicine, Division of Neurology, The Ottawa Hospital, Ottawa Hospital Research Institute, University of Ottawa, ¹⁰Neurology One, ¹¹Department of Neurology, Medical University of Graz, ¹²Department of Neurology, University of Medicine and Pharmacy Timisoara, ¹³AbbVie Inc, ¹⁴Servicio De Neurologia. Hospital Virgen Del Rocio

Objective:

To present real-world (RW) evidence on foslevodopa/foscarbidopa (LDp/CDp) effectiveness in patients earlier within advanced Parkinson’s disease (aPD).

Background:

LDp/CDp is a nonsurgical treatment delivered by 24-hour continuous subcutaneous infusion for people with aPD suffering from motor fluctuations uncontrolled on oral medications.

Design/Methods:

ROSSINI (NCT06107426) is an ongoing 3-year, multicountry, prospective, observational study of patients with aPD who are LDp/CDp-naïve (cohort A) or transitioning from LDp/CDp open-label extension studies (cohort B). The primary endpoint for cohort A is change from baseline to 6 months (M) in OFF time (h, Movement Disorder Society Unified Parkinson’s Disease Rating Scale Part IV modified item 4.3). Data from a pre-planned subgroup analysis of 3 subgroups earlier within aPD at baseline among the first 100 cohort A patients enrolled ≥6M are presented: (1) <65y of age and <10y disease duration (<65y+<10y); (2) device-aided therapy (DAT)-naïve; and (3) <5h OFF time.

Results:

Of 98 total cohort A patients in the full analysis set with available data, 12/98 (12.2%) patients were <65y+<10y, 92/98 (93.9%) were DAT-naïve, and 18/47 (38.3%) had <5h OFF time at baseline. From baseline to M6, those <65y+<10y showed similar reductions in OFF and dyskinesia time, and in 39-item Parkinson’s Disease Questionnaire (PDQ-39) scores (mean, 24.8/19.4 at baseline/M6 [n=7/3]) than the total population (least squares mean difference, -5.6). Outcome improvements between DAT-naïve patients and the total population were comparable. Patients with <5h OFF time showed nominally smaller percent reductions in OFF time (2.9h/1.9h [-34.5%]) than the total population (-2.8h [-52.9%]), larger increases in dyskinesia time (4.3h/0.8h [-81.4%] vs -1.8h [-53.2%]), and similar PDQ-39 score reductions (39.9/33.3 [-16.5%] vs -5.6 [-16.4%]).

Conclusions:

Interim results from small subgroups of patients earlier within aPD suggest that LDp/CDp therapy may yield similar RW improvements in motor complications and quality of life as the overall population. Further research with larger patient numbers is warranted.