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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037421
Receipt No. R000042538
Scientific Title An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease
Date of disclosure of the study information 2019/08/01
Last modified on 2020/01/27

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Basic information
Public title A study on improvement of cognitive function by istradefylline for parkinson disease
Acronym A study on improvement of cognitive function by istradefylline for parkinson disease
Scientific Title An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease
Scientific Title:Acronym A study on improvement of cognitive function by istradefylline for parkinson disease
Region
Japan

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

Objectives
Narrative objectives1 To validate whether istradefylline improves cognitive function of Parkinson disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary outcome is digit span test, arithmetic test, verval fluency test, Standard verbal paired-associate learning test, Benton visual retention test. These tests will be evaluated 12weeks later after starting treatment.
Key secondary outcomes Secondary outcomes are Movement Disorder Society-Unified Parkinson Disease Rating Scale(MDS-UPDRS),mini-mental state examination(MMSE), Non-motor symptoms scales and freezing of gait of questionnaire(FOG-Q).

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 Prescription istradefylline 20 mg for 1 month. If there are no side effects, We increase to 40 mg and prescribe for 2 months.
The assessments will be made in all patients participating the study, patients with MMSE scores of 26 or more, patients with MMSE score of less than 26.
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
40 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. The patients meet clinically established or clinically probable cases of clinical diagnostic criteria of Parkinson disease by Movement Disorder Society
2. The item of Attention/memory in NMSS is 1 or more.
3. The patient is treated with drugs that include L-dopa
4. The age of patients is 40 to 85years old.
5. Written consent has been obtained.
Key exclusion criteria 1. Mini mental state examination (MMSE) is 20 points or less.
2. Istradefylline has been prescribed
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Kanai
Organization Ichinomiya Nishi Hospital
Division name Neurology
Zip code 494-0001
Address 1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, Japan
TEL 0586480077
Email masabilliard35@yahoo.co.jp

Public contact
Name of contact person
1st name Masahiro
Middle name
Last name Kanai
Organization Ichinomiya Nishi Hospital
Division name Neurology
Zip code 494-0001
Address 1, Kaimei-hira, Ichinomiya-city, Aichi
TEL 0586480077
Homepage URL
Email masabilliard35@yahoo.co.jp

Sponsor
Institute Ichinomiya Nishi Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ichinomiya Nishi Hospital
Address 1, Kaimei-hira, Ichinomiya-city, Aichi
Tel 0586480077
Email matsubara@anzu.or.jp

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
2019 Year 08 Month 01 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
2019 Year 02 Month 01 Day
Date of IRB
2019 Year 02 Month 15 Day
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2021 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 18 Day
Last modified on
2020 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042538

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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