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Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease (APISJ Study)

APISJ Study (APISJ Study)

31

A total of 31 subjects with Parkinson's disease were enrolled in this study and 24 subjects were completed. Baseline characteristics of the subjects are follows- Age (years): 73.3[SD:7.74], height (cm): 154.3[8.62], weight (kg): 49.4[9.63], Sex: (male 13, female 18), duration of illness (years): 6.2[4.16], duration of motor complications (years): 3.2[4.35], MMSE: 27.4[2.06], mH&Y (ON: 2.4[0.63], OFF: 4.1[1.10]).

7, Apr 2017: the first participant enrolled 17, Jan 2019: the last participant (31st) enrolled 4, Jul 2019: the last participant (31st) completed

Three serious adverse events (rectal cancer, cervical vertebral body fracture, spinal fracture) were observed in this study. There was no causal relationship with the study drug. Adverse drug reactions (ADRs) were reported including malaise, dyskinesia exacerbation, and visual hallucinations in 6.5% each, Parkinson's disease exacerbation, wobble, dizziness, chest pain, and auditory hallucinations in 3.2% each. No serious ADRs were observed.

The primary outcome, of the change in UDRS, was significantly improved from baseline to week 24 with the treatment of study drug. The secondary outcome, of the change in UDRS sub-items, severity score in neck, right distal arm & hand and trunk were significantly improved from baseline to week 24, and none of other individual sub-item severity scores worsened. The change in the Movement Disorders Society Unified PD Rating Scale (MDS-UPDRS) part III score was significantly improved by the treatment of study drug. MDS-UPDRS part I, FOG-Q, CGI-I, and PDQ-8 scores, and mH&Y rating did not change significantly from baseline to week 24.

This is the first clinical study to investigate the efficacy of istradefylline, an adenosine A2A receptor antagonist, also known as a non-dopaminergic anti-parkinsonian agent, for the treatment of postural abnormality in patients with PD using UDRS as the primary outcome during the 24-week treatment. In the present study, Istradefylline was found to be effective for postural abnormalities in PD. Istradefylline may be a potential treatment option for postural abnormality in PD patients on levodopa treatment.

Mar. 31, 2021

Mar. 31, 2021

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs051180185

Takahashi Makio

Japanese Red Cross Osaka Hospital

5-30, Fudegasaki-Cho, Tennoji-ku, Osaka, Osaka 543-8555, Japan

ta@kuhp.kyoto-u.ac.jp

Takahashi Makio

Japanese Red Cross Osaka Hospital

5-30, Fudegasaki-Cho, Tennoji-ku, Osaka, Osaka 543-8555, Japan

+81-6-6774-5111

ta@kuhp.kyoto-u.ac.jp

Complete

Jan. 01, 2017

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) patients with wearing-off phenomena in parkinson's disease currently treated with levodopa-containing products
2) abnormal posture due to parkinson's disease within 2 years from onset of abnormal posture
3) at a stage of <= IV according to the modified hoehn and yahr scale (on state)
4) aged 30 years or older at the time of consent
5) patients who have given written consent. if the patient has difficulty in writing due to his or her condition, a representative may sign the written consent, subject to the patient's prior oral consent.

1) a score of <= 20 on the mini-mental state examination (MMSE)
2) patients with abnormal posture which is not derived from parkinson's disease (e.g. compressed fracture of backbone, fracture of the pelvis, drug-induced abnormal posture)
3) patients with impact for evaluation by such treatment as deep brain stimulation transcranial magnetic stimulation or electroconvulsive therapy et cetera.
4) current use or plan to administer levodopa/carbidopa intestinal gel
5) ongoing treatment with botulinus toxin or passed treatment with botulinus toxin within 6 months
6) ongoing treatment with istradefylline or passed treatment with istradefylline within 1 year
7) moderate to severe hepatic disorder or current treatment with a strong inhibitor of cyp3a4
8) lactating, pregnant, or possibly pregnant women
9) other conditions judged by the investigator or subinvestigator to be unsuitable for participation in the research

Both

Parkinson's disease

In this research, the duration of evaluation will be 24 weeks.
Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by Istradefylline.

Parkinson's disease

Change in the total UDRS score before and after administration of Istradefylline

Change in the total score of MDS-UPDRS Part I and Part III, each MDS-UPDRS Part I and Part III score, each UDRS score, mH&Y score (On/Off), FOG-Q score, CGI score and PDQ-8 score

+81-73-441-0714

Jan. 22, 2019

none