Early Phase II study of SND919 (Pramipexole) Tablets in Parkinson's disease.
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Accession number;03A0186283
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| Title;Early Phase II study of SND919 (Pramipexole) Tablets in Parkinson's disease. |
| Author;
MIZUNO YOSHIKUNI
(Juntendo Univ., School of Medicine, JPN)
KOWA HISAYUKI
(Kitasato Univ., East Hosp.)
YANAGISAWA NOBUO
(Shinshu Univ., School of Medicine, JPN)
KANAZAWA ICHIRO
(Univ. of Tokyo, Fac. of Med.)
KUNO SADAKO
(Kokuritsuryoyoshotanobyoin Shinkeinaika)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.19;NO.2;PAGE.179-204(2003)
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| Figure&Table&Reference;FIG.8, TBL.10, REF.21 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;To evaluate exploratorily the safety and efficacy of SND919 (pramipexole) in patient with Parkinson's disease without and with L-DOPA therapy, an early Phase II study was conducted in a open-label uncontrolled design. After completion of the study, some patients in whom SND919 therapy was judged necessary by the investigator were entered to the extended treatment phase. SND919 was initiated at a dose of 0.125 mg twice daily, and then the dose was gradually increased up to the maximum dose of 1.5 mg three times daily, as far as safety problem does not occur. The duration of the ascending/maintenance dose period was to be 8 weeks, and that of the descending dose period was to be up to 4 weeks. The primary variables total scores of UPDRS Part II and III at the final maintenance were significantly decreased (p < 0.001) compared with the respective baseline values in both groups without and with L-DOPA. Although adverse events were observed in 58.8% and 75.0% for subgroup without and with L-DOPA respectively, almost adverse events were mild to moderate and no serious adverse event was observed. There were no clinically significant changes in vital signs, ECG findings and clinical laboratory test. In the extended treatment phase, the efficacy of SND919 proved not to be attenuated during the long-term treatment over 1 year. Neither new nor more severe adverse events occurred during the long-term treatment with SND919, as compared with the preceding 8-week study. It is concluded that SND919 was effective for Parkinson's disease and that adverse events observed did not differ from those of other dopamine agonists, a confirmatory study to evaluate objectively the efficacy and safety of SND919 was deemed warranted. (author abst.) |
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