| Autor: |
Masahiro Nomoto, Masahiro Nagai, Noriko Nishikawa, Rina Ando, Yoshifumi Kagamiishi, Koji Yano, Shigeto Saito, Atsushi Takeda |
| Jazyk: |
angličtina |
| Rok vydání: |
2018 |
| Předmět: |
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| Zdroj: |
eNeurologicalSci, Vol 13, Iss , Pp 8-13 (2018) |
| Druh dokumentu: |
article |
| ISSN: |
2405-6502 |
| DOI: |
10.1016/j.ensci.2018.09.003 |
| Popis: |
We conducted a phase I study investigating the efficacy, safety, and tolerability of ONO-2160, a newly developed levodopa pro-drug, and carbidopa compared with levodopa and carbidopa to stabilize levodopa plasma concentration fluctuations in Japanese patients with Parkinson's disease. In an open-label two-period design, patients (n = 12) with Parkinson's disease received levodopa and carbidopa for 3 days before 7 days of treatment with ONO-2160 and carbidopa. Patients were primarily evaluated using the Unified Parkinson's Disease Rating Scale Part III, a Parkinson's disease symptom diary, and analysis of adverse events. Pharmacokinetic analysis of plasma levodopa concentration was also performed.ONO-2160 and carbidopa therapy stabilized effective plasma levodopa concentration. No adverse events with safety concerns were observed. The combination of ONO-2160 and carbidopa produced a prolonged and stable plasma levodopa concentration with a reduction in Unified Parkinson's Disease Rating Scale Part III total scores. The combination was well tolerated, with no safety concerns, when administered to Japanese patients with Parkinson's disease. Keywords: ONO-2160, Levodopa, Parkinson's disease, Motor fluctuations |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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