UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease.
Title of the study (Brief title)	Intervention Study of Istradefylline for the Treatment of Gait Disorders 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 gait disorders, as measured by the change in the total gait-related score of the MDS-UPDRS part III before and after administration of istradefylline in patients with advanced Parkinson's disease who have gait disorders.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in the total gait-related score of the MDS-UPDRS Part III before at Week 0 and after administration of istradefylline at Week 12
Key secondary outcomes	Change in the total score of each MDS-UPDRS part II (gait-related scores), New-FOG-Q, FOG-Q and PDQ-8 before and after administration of istradefylline, Gait analysis by a portable gait device

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 12 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Wearing-off phenomena in Parkinson's disease currently treated with levodopa-containing products 2)Gait disorders with freezing of gait due to Parkinson's disease 3)At a stage of <=IV according to the modified Hoehn and Yahr scale (ON state) 4)Aged 20 years or older at the time of consent 5)Written informed consent
Key exclusion criteria	1)Dementia or a score of <=23 on the Mini-Mental State Examination (MMSE) 2)Gait disturbance due to causes other than the underlying disease 3)Severe dyskinesia as assessed by the investigator or subinvestigator 4)Current treatment with istradefylline 5)Moderate to severe hepatic disorder or current treatment with a strong inhibitor of CYP3A4 6)Ongoing treatment with deep brain stimulation (DBS) and a condition requiring stimulation 7)Lactating, pregnant, or possibly pregnant women 8)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	Yasuyuki Okuma
Organization	Jyuntendo University Shizuoka Hospital
Division name	Neurology
Address	1129, Nagaoka, Izunokuni-city, Shizuoka, Japan
TEL	055-948-3111
Email	sgz02202@nifty.ne.jp

Public contact
Name of contact person	Yasuyuki Okuma
Organization	Juntendo University Shizuoka Hospital
Division name	Neurology
Address	1129, Nagaoka, Izunokuni-city, Shizuoka, Japan
TEL	055-948-3111
Homepage URL
Email	GDISJ.kyowa@kyowa-kirin.co.jp

Sponsor
Institute	Juntendo University Shizuoka Hospital
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	順天堂大学医学部附属静岡病院（静岡）、他

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 17 Day
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 21 Day
Last modified on	2018 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023424