UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026492 |
|---|---|
| Receipt number | 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 | 2019/09/11 11:18:44 |
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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
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
m.takahashi@osaka-med.jrc.or.jp
Sponsor or person
Institute
Osaka Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyowa 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
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
31
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
Terminated
Date of protocol fixation
| 2016 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
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 | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030405
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