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

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000026492
• Date of registration: 15/03/2017
• Prospective Registration: Yes
• Primary sponsor: Osaka Red Cross Hospital
• Public title: Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease
• Scientific title: Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease - Intervention Study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease.
• Date of first enrolment: 2017/03/15
• Target sample size: 30
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030405
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Takahashi Makio
• Affiliation: Osaka Red Cross Hospital Department of Neurology

• Name: Takahashi Makio
• Affiliation: Osaka Red Cross Hospital Department of Neurology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion 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

Age minimum: 30years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Parkinson's disease

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.

Primary Outcome(s)

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

Secondary Outcome(s)

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 PDQ8 score

Secondary ID(s)

jRCTs051180185

Source(s) of Monetary Support

Kyowa Kirin Co., Ltd

Secondary Sponsor(s)

Clinical Research Center, Wakayama Medical University

Ethics review

Status: YES
Approval date: 01/09/2016
Contact:

[e-mail]

Osaka Red Cross Hospital

06-6774-5111

[e-mail]

Results

• Results available: Yes
• Date Completed: 31/07/2019