Dataset Information

A Pooled Analysis From Phase 2b and 3 Studies in Japan of Istradefylline in Parkinson's Disease.

ABSTRACT:

Background

Characterization of patient factors associated with istradefylline efficacy may facilitate personally optimized treatment.

Objectives

We aimed to examine which patient factors are associated with favorable istradefylline treatment outcomes in PD patients with motor complications.

Methods

We performed a pooled analysis of data from two identical phase 2b and 3 Japanese studies of istradefylline. Logistic regression models were used to assess the association of 12 patient characteristics with favorable outcomes.

Results

Off time reduction and increased good on time with istradefylline provided a significantly favorable response in patients aged ≥65 years. Off time reduction was more favorable in patients with ≥8-hour daily off time at baseline. Improvement in UPDRS Part III was favorable in patients with UPDRS Part III baseline score ≥ 20.

Conclusions

Several patient factors influenced the effect of istradefylline on motor fluctuations, motor function, activities of daily living, and clinical impression. © 2020 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

SUBMITTER: Hattori N

PROVIDER: S-EPMC7496465 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Publications

A Pooled Analysis From Phase 2b and 3 Studies in Japan of Istradefylline in Parkinson's Disease.

Hattori Nobutaka N Kitabayashi Hiroki H Kanda Tomoyuki T Nomura Takanobu T Toyama Keizo K Mori Akihisa A

Movement disorders : official journal of the Movement Disorder Society 20200605 8

<h4>Background</h4>Characterization of patient factors associated with istradefylline efficacy may facilitate personally optimized treatment.<h4>Objectives</h4>We aimed to examine which patient factors are associated with favorable istradefylline treatment outcomes in PD patients with motor complications.<h4>Methods</h4>We performed a pooled analysis of data from two identical phase 2b and 3 Japanese studies of istradefylline. Logistic regression models were used to assess the association of 12 ...[more]

PMID: 32501582

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Project description:BackgroundAlthough levodopa is considered the most effective pharmacotherapy for motor symptoms of Parkinson's disease (PD), chronic use is associated with motor complications, including fluctuating response and unpredictable, involuntary movements called dyskinesia. ADS-5102 (amantadine) extended-release (ER) capsules (GOCOVRITM) is a recent US FDA-approved treatment for dyskinesia in PD patients. ADS-5102 is a high-dose, ER formulation of amantadine, administered orally once daily at bedtime, that achieves high plasma drug concentrations throughout the day.ObjectiveIn this study, we present pooled results from two randomized, double-blind, placebo-controlled, phase III ADS-5102 trials.Patients and methodsThe two studies in PD patients with dyskinesia shared design and eligibility criteria, differing only in treatment duration. Results from common assessment time points were pooled.ResultsAt 12 weeks, the least squares (LS) mean change in total score on the Unified Dyskinesia Rating Scale among 100 patients randomized to ADS-5102 and 96 patients randomized to placebo was - 17.7 (standard error [SE] 1.3) vs. - 7.6 (1.3) points, respectively (- 10.1 points, 95% confidence interval [CI] - 13.8, - 6.5; p < 0.0001). The relative treatment difference between groups was 27.3% (p < 0.0001). At 12 weeks, the LS mean change in OFF time was - 0.59 (0.21) vs. +0.41 (0.20) h/day, a difference of - 1.00 h/day (95% CI - 1.57, - 0.44; p = 0.0006). For both efficacy measures, a significant difference from placebo was attained by two weeks, the first post-baseline assessment, and was maintained throughout 12 weeks. In the pooled ADS-5102 group, the most common adverse events were hallucination, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension.ConclusionsThese analyses provide further evidence supporting ADS-5102 as an adjunct to levodopa for treating both dyskinesia and OFF time in PD patients with dyskinesia. Clinicaltrials.gov identifier: NCT02136914 and NCT02274766.

Dataset Information

A Pooled Analysis From Phase 2b and 3 Studies in Japan of Istradefylline in Parkinson's Disease.

Background

Objectives

Methods

Results

Conclusions

Publications

A Pooled Analysis From Phase 2b and 3 Studies in Japan of Istradefylline in Parkinson's Disease.

Similar Datasets

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