| Title: |
Long-term, continuous, subcutaneous levodopa/carbidopa infusion with ND0612 in Parkinson's disease: 3-year outcomes from the open-label BeyoND study |
| Authors: |
Ellenbogen, Aaron L.; Poewe, Werner; Espay, Alberto J.; Simuni, Tanya; Gurevich, Tanya; Yardeni, Tami; Lopes, Nelson; Sasson, Nissim; Case, Ryan; Stocchi, Fabrizio; Pazdera, Ladislav; Rizova, Yuliya; Azulay, Jean-Philippe; Danaila, Teodor; Defebvre, Luc; Durif, Franck; Roullet-Solignac, Isabelle; Ebersbach, Georg; Kassubek, Jan-Rainer; Muhlack, Siegfried; Schwarz, Johannes; Arkadir, David; Djaldetti, Ruth; Hassin-Baer, Sharon; Milo, Ron; Yahalom, Gilad; Antonini, Angelo; Bonuccelli, Ubaldo; Gasparoli, Elisabetta; Onofrj, Marco; Krawczyk, Malgorzata; Rejdak, Konrad; Rudzińska, Monika; Aldred, Jason; Aralu, Cletus; Bhatia, Perminder; Biton, Victor; Cutler, Barry; Flitman, Stephen; Gil, Ramon; Ginsberg, Paul; Greenberg, Jeffrey; Hauser, Robert A.; Isa, Arnaldo; Isaacson, Stuart; Klepitskaya, Olga; Klos, Kevin; Kumar, Rajeev; Leehey, Maureen; LeWitt, Peter; Patel, Neepa; Safirstein, Beth; Savitt, Joseph; Struck, Lynn; Taylor, Danette; Thomas, Karen; Truong, Daniel; Vasquez, Alberto |
| Contributors: |
Ellenbogen, Aaron L.; Poewe, Werner; Espay, Alberto J.; Simuni, Tanya; Gurevich, Tanya; Yardeni, Tami; Lopes, Nelson; Sasson, Nissim; Case, Ryan; Stocchi, Fabrizio; Pazdera, Ladislav; Rizova, Yuliya; Azulay, Jean-Philippe; Danaila, Teodor; Defebvre, Luc; Durif, Franck; Roullet-Solignac, Isabelle; Ebersbach, Georg; Kassubek, Jan-Rainer; Muhlack, Siegfried; Schwarz, Johanne; Arkadir, David; Djaldetti, Ruth; Hassin-Baer, Sharon; Milo, Ron; Yahalom, Gilad; Antonini, Angelo; Bonuccelli, Ubaldo; Gasparoli, Elisabetta; Onofrj, Marco; Krawczyk, Malgorzata; Rejdak, Konrad; Rudzińska, Monika; Aldred, Jason; Aralu, Cletu; Bhatia, Perminder; Biton, Victor; Cutler, Barry; Flitman, Stephen; Gil, Ramon; Ginsberg, Paul; Greenberg, Jeffrey; Hauser, Robert A.; Isa, Arnaldo; Isaacson, Stuart; Klepitskaya, Olga; Klos, Kevin; Kumar, Rajeev; Leehey, Maureen; Lewitt, Peter; Patel, Neepa; Safirstein, Beth; Savitt, Joseph; Struck, Lynn; Taylor, Danette; Thomas, Karen; Truong, Daniel; Vasquez, Alberto |
| Publisher Information: |
Elsevier Ltd |
| Publication Year: |
2025 |
| Collection: |
Padua Research Archive (IRIS - Università degli Studi di Padova) |
| Subject Terms: |
Infusion; Levodopa; Motor complication; ND0612; Parkinson's disease |
| Description: |
Introduction: ND0612 is being investigated as a continuous, subcutaneous levodopa/carbidopa infusion, in combination with oral levodopa/carbidopa, for motor fluctuations in Parkinson's disease (PD). One-year data from the ongoing BeyoND study (NCT02726386) showed that the ND0612 regimen was safe and well tolerated and provided a sustained ≥2-h improvement in daily Good ON-time through 12 months of treatment. Methods: We describe 3-year safety and efficacy outcomes for participants who completed 12 months of ND0612 treatment in the core study period and entered the extension phase. Results: Of the 214 enrolled participants, 120 completed the core 1-year period, and 114 participants continued into the extension phase. Of these, 95/114 (83.3 %) completed 2 years and 77/114 (67.5 %) completed 3 years of study treatment. Key reasons for discontinuation were treatment-emergent adverse events (TEAEs) (n = 5 and n = 11 after 2 and 3 years, respectively) and withdrawal of consent (n = 9 and n = 5, respectively). TEAEs were reported by 105/114 (92.1 %) participants in Year 1, 77/114 (67.5 %) in Year 2, and 73/95 (76.8 %) in Year 3. While most participants experienced infusion site reactions, these led to discontinuation in only five participants during this extension. At Month 36, the mean reduction in OFF-time from baseline was 2.81 h and the increase in Good ON-time was 2.79 h. Conclusions: Three-year results from this open-label study support the long-term safety, tolerability, and efficacy of ND0612. For participants who entered the extension phase, the high rate of retention supports a favorable benefit-risk ratio of the ND0612 regimen for patients with PD experiencing motor fluctuations. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/39884033; info:eu-repo/semantics/altIdentifier/wos/WOS:001416813800001; volume:132; journal:PARKINSONISM & RELATED DISORDERS; https://hdl.handle.net/11577/3551699 |
| DOI: |
10.1016/j.parkreldis.2025.107293 |
| Availability: |
https://hdl.handle.net/11577/3551699; https://doi.org/10.1016/j.parkreldis.2025.107293 |
| Rights: |
info:eu-repo/semantics/openAccess ; license:Creative commons ; license uri:http://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.8F11BF46 |
| Database: |
BASE |