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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020562
Receipt No. R000023741
Scientific Title Clinical efficacy and safety of istradefylline in the treatment of advanced Parkinson's disease: a retrospective study
Date of disclosure of the study information 2016/01/14
Last modified on 2017/08/02

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Basic information
Public title Clinical efficacy and safety of istradefylline in the treatment of advanced Parkinson's disease: a retrospective study
Acronym Clinical efficacy and safety of istradefylline in the treatment of advanced Parkinson's disease: a retrospective study
Scientific Title Clinical efficacy and safety of istradefylline in the treatment of advanced Parkinson's disease: a retrospective study
Scientific Title:Acronym Clinical efficacy and safety of istradefylline in the treatment of advanced Parkinson's disease: a retrospective study
Region
Japan

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

Objectives
Narrative objectives1 To evaluate clinical efficacy and safety of istradefylline in patients with advanced Parkinson's disease in a retrospective manner
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical Global Impression-Improvement(CGI-I)
Improvement for each motor symptom
Key secondary outcomes Safety

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 ・Patients who received istradefylline in the period from May 2013 to May 2015
・Parkinson's disease patients having wearing-off phenomenon under treatment with medications containing levodopa
・Outpatient
Key exclusion criteria ・Patients who have moderate or severer hepatic disorder or are receiving strong CYP3A4 inhibitors.
・Women who are lactating or pregnant or are suspected of being pregnant.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuto Higashi
Organization Himeji Central Hospital
Division name Neurology
Zip code
Address 2-36, Miyake, Shikama-ku, Himeji-city, Hyogo-pref
TEL 079-235-7331
Email yasuto@mvj.biglobe.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuto Higashi
Organization Himeji Central Hospital
Division name Neurology
Zip code
Address 2-36, Miyake, Shikama-ku, Himeji-city, Hyogo-pref
TEL 079-235-7331
Homepage URL
Email yasuto@mvj.biglobe.ne.jp

Sponsor
Institute Himeji Central 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)

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 01 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Of 53 patients evaluable for efficacy, 41.5% (n=22) were minimally improved and 17.0% (n=9) much improved on CGI-I scale, accounting for 58.5% of minimally improved + much improved.
Proportion of patients with minimally improved + much improved was 48.1% (13/27 patients) and 69.2% (18/26 patients) in those on a maintenance dose of 20 mg and 40 mg of istradefylline, respectively. 
Regarding each motor symptom, significant improvement was observed for gait disorder (47.9%) and postural disorder (43.3%). 
Adverse events were reported in 15 of 65 patients (23.1%).

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
2015 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Clinical efficacy (Clinical Global Impression-Improvement and improvement for each motor symptom) and safety after treatment with istradefylline were evaluated in a retrospective manner

Management information
Registered date
2016 Year 01 Month 14 Day
Last modified on
2017 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023741

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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