APISJ Study

JRCT ID: jRCTs051180185

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 07/04/2017
• Target sample size: 30
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: Change in the total UDRS score before and after administration of Istradefylline
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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

Related Information

• Primary Sponsor: Takahashi Makio
• Secondary Sponsor: Kyowa Kirin Co., Ltd.
• Secondary ID(s): UMIN000026492