UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020562
Receipt number 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 13:45:41

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Himeji Central Hospital

Institute

Department

Personal name



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

Value
https://center6.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