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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026492
Receipt No. R000030405
Scientific Title Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease
Date of disclosure of the study information 2017/03/15
Last modified on 2019/03/27

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Basic information
Public title Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease
Acronym Intervention Study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease.
Scientific Title Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease
Scientific Title:Acronym Intervention Study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease.
Region
Japan

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

Objectives
Narrative objectives1 This research will be conducted to evaluate the clinical efficacy of istradefylline for abnormal posture before and after administration of istradefylline in patients with Parkinson's disease who has wearing off and abnormal posture.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in the total UDRS score before and after administration of istradefylline
Key secondary outcomes Change in the total score of MDS-UPDRS Part I and Part III, each MDS-UPDRS Part I and Part III score, each UDRS score, mH&Y score (On/Off), FOG-Q score, CGI score and PDQ8 score

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In this research, the duration of evaluation will be 24 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

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) patients with wearing-off phenomena in parkinson's disease currently treated with levodopa-containing products
2) abnormal posture due to parkinson's disease within 2 years from onset of abnormal posture
3) at a stage of <= iv according to the modified hoehn and yahr scale (on state)
4) aged 30 years or older at the time of consent
5) patients who have given written consent. if the patient has difficulty in writing due to his or her condition, a representative may sign the written consent, subject to the patient's prior oral consent.
Key exclusion criteria 1) A score of <= 20 on the mini-mental state examination (mmse)
2) patients with abnormal posture which is not derived from parkinson's disease (e.g. compressed fracture of backbone, fracture of the pelvis, drug-induced abnormal posture)
3) patients with impact for evaluation by such treatment as deep brain stimulation transcranial magnetic stimulation or electroconvulsive therapy et cetera.
4) current use or plan to administer levodopa/carbidopa intestinal gel
5) ongoing treatment with botulinus toxin or passed treatment with botulinus toxin within 6 months
6) ongoing treatment with istradefylline or passed treatment with istradefylline within 1 year
7) moderate to severe hepatic disorder or current treatment with a strong inhibitor of cyp3a4
8) lactating, pregnant, or possibly pregnant women
9) other conditions judged by the investigator or subinvestigator to be unsuitable for participation in the research
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Takahashi
Middle name
Last name Makio
Organization Osaka Red Cross Hospital
Division name Department of Neurology
Zip code 543-8555
Address 5-30, Fudegasaki-cho, Tennoji-ku, Osaka 543-8555
TEL 06-6774-5111
Email m.takahashi@osaka-med.jrc.or.jp

Public contact
Name of contact person
1st name Takahashi
Middle name
Last name Makio
Organization Osaka Red Cross Hospital
Division name Department of Neurology
Zip code 543-8555
Address 5-30, Fudegasaki-cho, Tennoji-ku, Osaka 543-8555
TEL 06-6774-5111
Homepage URL
Email m.takahashi@osaka-med.jrc.or.jp

Sponsor
Institute Osaka Red Cross 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 Clinical Research Center, Wakayama Medical University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka Red Cross Hospital
Address 5-30, Fudegasaki-cho, Tennoji-ku, Osaka
Tel 06-6774-5111
Email m.takahashi@osaka-med.jrc.or.jp

Secondary IDs
Secondary IDs YES
Study ID_1 jRCTs051180185
Org. issuing International ID_1 jRCT
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪赤十字病院、他
Osaka Red Cross Hospital, Ohters

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 15 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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 10 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030405

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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