Impact of istradefylline on motor and non-motor symptoms in patients with Parkinson’s disease: Subanalysis of the ISTRA ADJUST PD

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Introduction Parkinson’s disease (PD) presents with diverse motor and non-motor symptoms, some of which do not fully respond to dopamine replacement therapy. To clarify the effects of the adenosine A 2A receptor antagonist istradefylline (IST) on PD symptoms, we conducted a subanalysis of the 37-week ISTRA ADJUST PD randomized controlled trial. Methods Patients with PD experiencing wearing-off with levodopa at 300–400 mg/day were randomized 1:1 to receive IST or no IST (control). Levodopa doses were titrated according to clinical severity throughout the study. PD symptoms were assessed using the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) and Parkinson’s Disease Questionnaire-39 (PDQ-39). Results The efficacy analyses included 105 patients (IST, n = 52; control, n = 53). Regarding MDS-UPDRS subitems in patients in the IST group, significant improvements ( p < 0.05) were observed at week 36 compared with baseline for both motor (e.g., facial expression, rigidity, finger tapping, toe tapping, time spent in the off state, and complexity of motor fluctuation) and non-motor (e.g., daytime sleepiness, fatigue, and doing hobbies and other activities) symptoms. In patients in the control group, significant improvements ( p < 0.05) were observed for motor symptoms only. Regarding PDQ-39 subitems in patients in the IST group, significant improvements ( p < 0.05) were observed at week 36 compared with baseline in doing up buttons or shoelaces, writing, feeling angry or bitter, and unexpectedly falling asleep during the day. Conclusion IST can improve motor and non-motor symptoms and quality of life suggesting that it provides more comprehensive improvement in PD symptoms than increasing the levodopa dose alone. Clinical trial registration: Japan Registry of Clinical Trials; study ID: jRCTs031180248.

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