UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003160 |
|---|---|
| Receipt number | R000003834 |
| Scientific Title | Clinical trial of Amantadine HCl for hypoxic encephalopathy |
| Date of disclosure of the study information | 2010/02/09 |
| Last modified on | 2020/04/27 07:49:14 |
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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)
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
hamano@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui, Crinical Trial and Advanced Medical Center
Institute
Department
Personal name
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
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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 09 | Month | 01 | Day |
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
| 2020 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003834
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
