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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003160
Receipt No. R000003834
Scientific Title Clinical trial of Amantadine HCl for hypoxic encephalopathy
Date of disclosure of the study information 2010/02/09
Last modified on 2010/02/09

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Basic information
Public title Clinical trial of Amantadine HCl for hypoxic encephalopathy
Acronym Amantadine HCl for hypoxic encephalopathy
Scientific Title Clinical trial of Amantadine HCl for hypoxic encephalopathy
Scientific Title:Acronym Amantadine HCl for hypoxic encephalopathy
Region
Japan

Condition
Condition Hypoxic encephalopathy
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Post-hypoxic encephalopathy is a disorder caused by the reduction of cerebral circulation by various causes. Number of patients are not small. But effective therapeutics are not developed, yet. Amantadine HCl stimulates the secretion of the dopamine from the substantia nigra, and shows therapeutic effect for Parkinsons syndrome. Amantadine HCl is also effective for patients with the sequlea of cerebral infarction. Our preliminary results showed that amantadine HCl improved the activity, and mentality of the patients with post-hypoxic encephalopathy. Some patients could speak following amantadine HCl administration. The objective of this study is to examine the therapeutic effect of amantadine HCl for post-hypoxic encephalopathy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Mini-mental state examination test
WAIS-R
FIM
Key secondary outcomes FDG-PET findings

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 Administration of amantadine HCl
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
90 years-old >
Gender Male and Female
Key inclusion criteria The patients showed neurological deficits following the various causes of hypoxicemia.
Key exclusion criteria The patients, previously showed allergic reactions following amantadine HCl administration.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadanori Hamano
Organization University of Fukui
Division name Second Department of Internal Medicine
Zip code
Address 23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193 Japan
TEL 0776-61-3111(2300)
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tadanori Hamano
Organization University of Fukui
Division name Second Department of Internal Medicine
Zip code
Address 23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193 Japan
TEL 0776-61-3111(2300)
Homepage URL
Email hamano@u-fukui.ac.jp

Sponsor
Institute University of Fukui, Crinical Trial and Advanced Medical Center
Institute
Department

Funding Source
Organization University of Fukui, Crinical Trial and Advanced Medical Center
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 福井大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 09 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
2009 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 02 Month 09 Day
Last modified on
2010 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003834

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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