UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Long-term efficacy and safety of istradefylline for the treatment of advanced Parkinson's disease
Title of the study (Brief title)	Long-term efficacy and safety of istradefylline for the treatment of advanced Parkinson's disease
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the long-term efficacy and safety of istradefylline in patients with advanced Parkinson's disease, in an observational study setting, by using data collected from daily medical practice
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	UPDRS partIII(before treatment and at 3, 6 and 12 months after treatment)
Key secondary outcomes	off-time,UPDRS partII,CGI,BDI-II,JESS,MMSE,safety(before treatment and at 3, 6 and 12 months after treatment)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Parkinson's disease patients experiencing the "wearing off" phenomenon while receiving therapy with L-dopa preparations 2.Outpatients of clinical research centers who had been taking istradefylline for more than 12 months 3.Patients at least 20 years of age during the reporting period
Key exclusion criteria	1.Patients with moderate or severe liver disorder or taking medications that strongly inhibit CYP3A4 2.Patients who are nursing or pregnant or might be pregnant 3.Patients in whom efficacy data were not collected at 6 and 12 months after oral treatment with istradefylline
Target sample size	45

Research contact person
Name of lead principal investigator	Takashi Abe
Organization	Abe Neurology Clinic
Division name	Neurology
Address	6-6,Sakanacho,morioka-shi,Iwate,Japan
TEL	019-606-3711
Email	ryuabe@crest.ocn.ne.jp

Public contact
Name of contact person	Sayumi Hasegawa
Organization	QOL RD Co.,Ltd.
Division name	CRO Division
Address	2-14-1,Nihonbashi,Chuo-ku,Tokyo,Japan
TEL	03-6386-9500
Homepage URL
Email	s-hasegawa@qol-rd.co.jp

Sponsor
Institute	Abe Neurology Clinic
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 14 Day
Anticipated trial start date	2016 Year 01 Month 21 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	Among patients who had been visiting the clinical research centers between May 2013 and 30th September 2015, those receiving istradefylline, a Parkinson's disease treatment, for more than 12 months will be selected and the long-term clinical efficacy and safety of istradefylline will be evaluated based on patient demographic data (age, gender, drug history, medical history/concurrent conditions, H&Y stage, disease duration, history of DBS and others), clinical evaluation related to Parkinson's disease (UPDRS, CGI), non-motor symptoms, associated symptoms of the disease (BDI-II, JESS), MMSE, and clinical data related to safety. Endpoints were evaluated before treatment and at 3, 6 and 12 months after treatment.

Management information
Registered date	2016 Year 04 Month 13 Day
Last modified on	2016 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025115