Efficacy and safety of istradefylline in patients with Parkinson's disease presenting with postural abnormalities: Results from a multicenter, prospective, and open-label exploratory study in Japan

Postural abnormalities in Parkinson's disease (PD) can devastatingly impair the quality of life, especially in patients with advanced disease, and are generally refractory to dopaminergic agents. The objective of this exploratory study was to investigate the efficacy and safety of istradefyllin...

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Published in:Journal of the neurological sciences 2022-01, Vol.432, p.120078-120078, Article 120078
Main Authors: Takahashi, Makio, Shimokawa, Toshio, Koh, Jinsoo, Takeshima, Takao, Yamashita, Hirofumi, Kajimoto, Yoshinori, Mori, Akihisa, Ito, Hidefumi
Format: Article
Language:English
Subjects:
Adenosine A2 Receptor Antagonists
Adenosine A2A receptor antagonist
Antiparkinson Agents - adverse effects
Humans
Istradefylline
Japan
Levodopa - adverse effects
Parkinson Disease - complications
Parkinson Disease - drug therapy
Parkinson's disease
Postural abnormality
Prospective Studies
Purines
Quality of Life
Treatment Outcome
Unified Dystonia Rating Scale (UDRS)
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Summary:Postural abnormalities in Parkinson's disease (PD) can devastatingly impair the quality of life, especially in patients with advanced disease, and are generally refractory to dopaminergic agents. The objective of this exploratory study was to investigate the efficacy and safety of istradefylline for the treatment of postural abnormalities in PD. In this open-label, 24-week, single-arm prospective trial, PD patients with postural abnormalities experiencing the wearing-off phenomenon on levodopa-containing therapies were enrolled and received a starting dose of 20 mg/day istradefylline orally for 4 weeks, which was then increased to 40 mg/day. The primary endpoint was the change from baseline to week 24 in the 14-item Unified Dystonia Rating Scale (UDRS) total score. Pivotal secondary endpoints were changes in the sub-items of UDRS, Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III, and adverse drug reactions (ADRs). Overall, 24/31 enrolled patients completed the study; mean (standard deviation) age and duration of motor complications were 73.3 (7.7) years and 3.2 (4.4) years, respectively. Mean (95% confidence interval [CI]) change in the UDRS total score was 4.84 (1.97, 7.71; P = 0.002), with significant improvements in the neck, right distal arm and hand, and trunk severity scores. Mean (95% CI) change in the MDS-UPDRS part III score was 7.84 (4.34, 11.34; P 
ISSN:0022-510X
1878-5883
DOI:10.1016/j.jns.2021.120078