Impact of Uncontrolled Motor Fluctuations in Parkinson's Disease: Real-World Insights from the PROSPECT Observational Study.
Impact of Uncontrolled Motor Fluctuations in Parkinson's Disease: Real-World Insights from the PROSPECT Observational Study.
Where did the research take place?
The study site has not been established. Author addresses may differ from where the research occurred.
Cincinnati, US · Author affiliation
University of Cincinnati Gardner Neuroscience Institute, Gardner Family Center for Parkinson's Disease and Movement Disorders, Department of Neurology, University of Cincinnati, 234 Goodman Street, Cincinnati, OH, 45219, USA. espayaj@ucmail.uc.edu.Location evidence
Lille, FR · Author affiliation
Movement Disorders Department, Lille Neurosciences and Cognition, CHU Lille, Lille University, Lille, France.Location evidence
Barcelona, ES · Author affiliation
Department of Neurology, Vall d,Hebron Institut de Recerca (VHIR), Vall d'Hebron Hospital Universitari, Universitat Autònoma de Barcelona, Barcelona, Spain.Location evidence
US · Author affiliation · country only
Inova Parkinson's and Movement Disorders Center, Falls Church, VA, USA.Location evidence
Sagamihara, JP · Author affiliation
Department of Neurology, NHO Sagamihara National Hospital, Kanagawa, Japan.Location evidence
New Orleans, US · Author affiliation
Department of Neurology, Ochsner Clinic Foundation, New Orleans, LA, USA.Location evidence
Newcastle upon Tyne, GB · Author affiliation
Department of Neurology, Newcastle Hospitals, Newcastle Upon Tyne, UK.Location evidence
Brisbane, AU · Author affiliation
Department of Neurology, Princess Alexandra Hospital, Brisbane, QLD, Australia.Location evidence
Ottawa, CA · Author affiliation
Division of Neurology, Department of Medicine, The Ottawa Hospital, Ottawa Hospital Research Institute, Ottawa, ON, Canada.Location evidence
Kyoto, JP · Author affiliation
Clinical Research Center and Department of Neurology, National Hospital Organization Unato National Hospital, Kyoto, Japan.Location evidence
Toulouse, FR · Author affiliation
Department of Neurology, University Hospital of Toulouse, Toulouse, France.Location evidence
Calgary, CA · Author affiliation
Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada.Location evidence
Oregon, US · Author affiliation
Department of Neurology, Oregon Health and Science University, Portland, OR, USA.Location evidence
Sydney, AU · Author affiliation
Real World Evidence and Analytics, Fortrea, Sydney, NSW, Australia.Location evidence
North Chicago, US · Author affiliation
AbbVie Inc, North Chicago, IL, USA.Location evidence
Majadahonda, ES · Author affiliation
Movement Disorders Unit, Neurology Department, Hospital U Puerta de Hierro, Majadahonda, Madrid, Spain.Location evidence
Madrid, ES · Author affiliation
Movement Disorders Unit, Neurology Department, Hospital U Puerta de Hierro, Majadahonda, Madrid, Spain.Location evidence
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Original abstract
INTRODUCTION: Limited real-world data exist around the long-term impact of uncontrolled motor fluctuations in Parkinson's disease (PD). With this first-ever, prospective, observational study, we sought to describe real-world treatment patterns and longitudinal outcomes of patients with PD and motor fluctuations inadequately controlled by oral medications. METHODS: PROSPECT was a 24-month multicountry observational study that included 229 adults with idiopathic PD and uncontrolled motor fluctuations (≥ 2.5 h/day "off" time) on optimized oral PD medications who were device-aided therapy-naive. Treatment modifications, including adding device-aided therapy, were made as part of routine clinical care and were not assigned by the study. Assessments included change from baseline (CFB) in motor and non-motor symptoms, activities of daily living (ADL; MDS-UPDRS Part II), and quality of life (QoL; EQ-5D-5L, PDQ-39). Outcomes were adjusted for baseline differences using linear regression. Subgroup analyses were performed among those who remained on oral PD medications only and those who initiated device-aided therapy. RESULTS: Most patients (80.3%, n = 184) remained solely on oral PD medications due to clinician not offering or patient refusal, and showed a small reduction in "off" time (CFB - 0.7 h/day, p = .006) at 24 months, with nominal decline in ADL (CFB = 1.5, p = .010) and QoL (PDQ-39 CFB = 2.6, p = .010; EQ-5D-5L CFB = - 0.04, p = .017). Approximately half (49.8%, n = 114) were offered device-aided therapy, of whom 44.7% (n = 51/114) declined, mainly citing needing time to decide or perception as unnecessary. Patients who initiated device-aided therapy (19.7%, n = 45) showed a meaningful "off" time reduction (CFB = - 2.2 h/day, p < .0001) and no change in ADL and QoL at 24 months, versus slight worsening with oral medications only. CONCLUSION: Despite device-aided therapy eligibility, most patients with PD remained exclusively on oral medications. Device-aided therapy initiation was associated with improved motor symptoms, while those who remained on oral medications showed no meaningful change.