Application of the ‘5-2-1’ Screening Criteria in Advanced Parkinson’s Disease: Interim Analysis of DUOGLOBE
Jason Aldred, Marieta Anca‐Herschkovitsch, Angelo Antonini, Ovidiu Băjenaru, Lars Bergmann, Paul Bourgeois, Esther Cubo, Thomas L. Davis, Robert Iansek, Norbert Kovács, Pavnit Kukreja, Koray Onuk, Francesco E. Pontieri, Weining Robieson, Mustafa Siddiqui, Mihaela Simu, David G. Standaert, К. Ray Chaudhuri
Abstract
Aim: A Delphi expert consensus panel proposed that fulfilling ≥1 of the ‘5-2-1 criteria’ (≥five-times daily oral levodopa use, ≥two daily hours with ‘Off’ symptoms or ≥one daily hour with troublesome dyskinesia) suggests advanced Parkinson’s disease (PD). Patients & methods: DUOdopa/Duopa in Patients with Advanced PD – a GLobal OBservational Study Evaluating Long-Term Effectiveness (DUOGLOBE) – is a single-arm, postmarketing, observational, long-term effectiveness study of levodopa–carbidopa intestinal gel (LCIG) for advanced PD. Results: This 6-month interim analysis (n = 139) affirms that most (98%) enrolled patients fulfill ≥1 of the 5-2-1 criteria. These patients responded favorably to LCIG treatment. Safety was consistent with other LCIG studies. Conclusion: In advanced PD patients, the 5-2-1 criteria generally aligns with clinician assessment. Clinical Trial Registration: NCT02611713 (ClinicalTrials.gov)