UMIN-CTR Clinical Trial

Basic information
Public title	Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease
Acronym	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
Scientific Title:Acronym	Intervention Study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease.
Region	Japan

Condition
Condition	Parkinson's disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This research will be conducted to evaluate the clinical efficacy of istradefylline for abnormal posture before and after administration of istradefylline in patients with Parkinson's disease who has wearing off and abnormal posture.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in the total UDRS score before and after administration of istradefylline
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion 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.
Key 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
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Takahashi Middle name Last name Makio
Organization	Osaka Red Cross Hospital
Division name	Department of Neurology
Zip code	543-8555
Address	5-30, Fudegasaki-cho, Tennoji-ku, Osaka 543-8555
TEL	06-6774-5111
Email	m.takahashi@osaka-med.jrc.or.jp

Public contact
Name of contact person	1st name Takahashi Middle name Last name Makio
Organization	Osaka Red Cross Hospital
Division name	Department of Neurology
Zip code	543-8555
Address	5-30, Fudegasaki-cho, Tennoji-ku, Osaka 543-8555
TEL	06-6774-5111
Homepage URL
Email	m.takahashi@osaka-med.jrc.or.jp

Sponsor
Institute	Osaka Red Cross Hospital
Institute
Department

Funding Source
Organization	Kyowa Kirin Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Clinical Research Center, Wakayama Medical University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka Red Cross Hospital
Address	5-30, Fudegasaki-cho, Tennoji-ku, Osaka
Tel	06-6774-5111
Email	m.takahashi@osaka-med.jrc.or.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTs051180185
Org. issuing International ID_1	jRCT
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	大阪赤十字病院、他 Osaka Red Cross Hospital, Ohters

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	31
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 08 Month 02 Day
Date of IRB	2016 Year 09 Month 01 Day
Anticipated trial start date	2017 Year 03 Month 15 Day
Last follow-up date	2019 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 03 Month 10 Day
Last modified on	2019 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030405