دورية أكاديمية
Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson’s Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study
| العنوان: | Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson’s Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study |
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| المؤلفون: | Jason Aldred, Eric Freire-Alvarez, Alexander V. Amelin, Angelo Antonini, Bruno Bergmans, Filip Bergquist, Manon Bouchard, Kumar Budur, Camille Carroll, K. Ray Chaudhuri, Susan R. Criswell, Erik H. Danielsen, Florin Gandor, Jia Jia, Thomas E. Kimber, Hideki Mochizuki, Weining Z. Robieson, Amy M. Spiegel, David G. Standaert, Saritha Talapala, Maurizio F. Facheris, Victor S. C. Fung |
| المصدر: | Neurology and Therapy, Vol 12, Iss 6, Pp 1937-1958 (2023) |
| بيانات النشر: | Adis, Springer Healthcare, 2023. |
| سنة النشر: | 2023 |
| المجموعة: | LCC:Neurology. Diseases of the nervous system |
| مصطلحات موضوعية: | Advanced Parkinson’s disease, Foslevodopa/foscarbidopa, Levodopa/carbidopa prodrugs, Motor fluctuations, Subcutaneous infusion, Neurology. Diseases of the nervous system, RC346-429 |
| الوصف: | Abstract Introduction Foslevodopa/foscarbidopa, a soluble formulation of levodopa/carbidopa (LD/CD) prodrugs for the treatment of Parkinson’s disease (PD), is administered as a 24-hour/day continuous subcutaneous infusion (CSCI) with a single infusion site. The efficacy and safety of foslevodopa/foscarbidopa versus oral immediate-release LD/CD was previously demonstrated in patients with PD in a 12-week, randomized, double-blind, phase 3 trial (NCT04380142). We report the results of a separate 52-week, open-label, phase 3 registrational trial (NCT03781167) that evaluated the safety/tolerability and efficacy of 24-hour/day foslevodopa/foscarbidopa CSCI in patients with advanced PD. Methods Male and female patients with levodopa-responsive PD and ≥ 2.5 hours of “Off” time/day received 24-hour/day foslevodopa/foscarbidopa CSCI at individually optimized therapeutic doses (approximately 700–4250 mg of LD per 24 hours) for 52 weeks. The primary endpoint was safety/tolerability. Secondary endpoints included changes from baseline in normalized “Off” and “On” time, percentage of patients reporting morning akinesia, Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), Parkinson’s Disease Sleep Scale–2 (PDSS-2), 39-item Parkinson’s Disease Questionnaire (PDQ-39), and EuroQol 5-dimension questionnaire (EQ-5D-5L). Results Of 244 enrolled patients, 107 discontinued, and 137 completed treatment. Infusion site events were the most common adverse events (AEs). AEs were mostly nonserious (25.8% of patients reported serious AEs) and mild/moderate in severity. At week 52, “On” time without troublesome dyskinesia and “Off” time were improved from baseline (mean [standard deviation (SD)] change in normalized “On” time without troublesome dyskinesia, 3.8 [3.3] hours; normalized “Off” time, −3.5 [3.1] hours). The percentage of patients experiencing morning akinesia dropped from 77.7% at baseline to 27.8% at week 52. Sleep quality (PDSS-2) and quality of life (PDQ-39 and EQ-5D-5L) also improved. Conclusion Foslevodopa/foscarbidopa has the potential to provide a safe and efficacious, individualized, 24-hour/day, nonsurgical alternative for patients with PD. Trial Registration Number ClinicalTrials.gov identifier NCT03781167. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 2193-8253 2193-6536 |
| Relation: | https://doaj.org/toc/2193-8253; https://doaj.org/toc/2193-6536 |
| DOI: | 10.1007/s40120-023-00533-1 |
| URL الوصول: | https://doaj.org/article/3c28527413ce4845845ba7b0a3dbeb25 |
| رقم الأكسشن: | edsdoj.3c28527413ce4845845ba7b0a3dbeb25 |
| قاعدة البيانات: | Directory of Open Access Journals |
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Full Text Finder | تدمد: | 21938253 21936536 |
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| DOI: | 10.1007/s40120-023-00533-1 |