UMIN-CTR Clinical Trial

Public title

Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease.

Acronym

Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease.

Scientific Title

Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease.

Scientific Title:Acronym

Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease.

Region

Japan

Condition

Parkinson's disease

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Yasuyuki Okuma

Organization

Jyuntendo University Shizuoka Hospital

Division name

Neurology

Zip code

Address

1129, Nagaoka, Izunokuni-city, Shizuoka, Japan

TEL

055-948-3111

Email

sgz02202@nifty.ne.jp

Name of contact person

1st name
Middle name
Last name	Yasuyuki Okuma

Organization

Juntendo University Shizuoka Hospital

Division name

Neurology

Zip code

Address

1129, Nagaoka, Izunokuni-city, Shizuoka, Japan

TEL

055-948-3111

Homepage URL

Email

GDISJ.kyowa@kyowa-kirin.co.jp

Institute

Juntendo University Shizuoka Hospital

Institute

Department

Personal name

Organization

Kyowa Hakko Kirin Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

順天堂大学医学部附属静岡病院（静岡）、他

Date of disclosure of the study information

2015

Year

12

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

10

Month

17

Day

Date of IRB

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

Other related information

Registered date

2015

Year

12

Month

21

Day

Last modified on

2018

Year

08

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023424