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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021899
Receipt No. R000025115
Scientific Title Long-term efficacy and safety of istradefylline for the treatment of advanced Parkinson's disease
Date of disclosure of the study information 2016/04/13
Last modified on 2016/07/27

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Basic information
Public title Long-term efficacy and safety of istradefylline for the treatment of advanced Parkinson's disease
Acronym Long-term efficacy and safety of istradefylline for the treatment of advanced Parkinson's disease
Scientific Title Long-term efficacy and safety of istradefylline for the treatment of advanced Parkinson's disease
Scientific Title:Acronym 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)

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

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
1st name
Middle name
Last name Takashi Abe
Organization Abe Neurology Clinic
Division name Neurology
Zip code
Address 6-6,Sakanacho,morioka-shi,Iwate,Japan
TEL 019-606-3711
Email ryuabe@crest.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sayumi Hasegawa
Organization QOL RD Co.,Ltd.
Division name CRO Division
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Completed
Date of protocol fixation
2016 Year 01 Month 14 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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