Parkinsonism & related disorders · 2014
Sustained efficacy of apomorphine in Japanese patients with advanced Parkinson's disease.
Клиническое исследование III фазыСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Hattori Nobutaka, Nomoto Masahiro, 6500-004 Study Group
Аннотация
BACKGROUND: This report presents data from one of the first trials of apomorphine rescue treatment for advanced Parkinson's disease (PD) conducted in Japan. This 3 month trial aimed to evaluate the sustainability of efficacy of intermittent apomorphine rescue treatment.
METHODS: A phase III, double-blind, placebo-controlled trial was conducted in PD patients (n = 31) with motor fluctuations in spite of individually titrated treatment with levodopa and other anti PD. Intermittent treatment was titrated to the maintenance dose with a subsequent unblind 12-week outpatient phase. At the week-12 visit, response to apomorphine or placebo was assessed as primary efficacy endpoint using the Unified Parkinson's Disease Rating Scale (UPDRS) part III (Motor Examination) under double-blind crossover conditions.
RESULTS: In the crossover phase (n = 28), least squares mean changes in the UPDRS part III score from pre-dose were -24.5 points with apomorphine and -2.3 points with placebo, showing that apomorphine, compared with placebo, provided a significantly greater improvement in the UPDRS part III score change (difference between treatments: -22.1 [95% confidence interval, -27.8, -16.4]; P < 0.001). The most frequently reported adverse events during the study were increased eosinophil count (8 patients), nausea (7), somnolence (6), dyskinesia (5), yawning (5), and decreased blood pressure (3).
CONCLUSIONS: Our results indicate that a 3-month use of intermittent apomorphine is an effective rescue therapy for "off" episodes in advanced PD patients.
METHODS: A phase III, double-blind, placebo-controlled trial was conducted in PD patients (n = 31) with motor fluctuations in spite of individually titrated treatment with levodopa and other anti PD. Intermittent treatment was titrated to the maintenance dose with a subsequent unblind 12-week outpatient phase. At the week-12 visit, response to apomorphine or placebo was assessed as primary efficacy endpoint using the Unified Parkinson's Disease Rating Scale (UPDRS) part III (Motor Examination) under double-blind crossover conditions.
RESULTS: In the crossover phase (n = 28), least squares mean changes in the UPDRS part III score from pre-dose were -24.5 points with apomorphine and -2.3 points with placebo, showing that apomorphine, compared with placebo, provided a significantly greater improvement in the UPDRS part III score change (difference between treatments: -22.1 [95% confidence interval, -27.8, -16.4]; P < 0.001). The most frequently reported adverse events during the study were increased eosinophil count (8 patients), nausea (7), somnolence (6), dyskinesia (5), yawning (5), and decreased blood pressure (3).
CONCLUSIONS: Our results indicate that a 3-month use of intermittent apomorphine is an effective rescue therapy for "off" episodes in advanced PD patients.