UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002332 |
|---|---|
| Receipt number | R000002852 |
| Scientific Title | Clinical research on a neuroprotective effect of minocycline treatment in the acute stage of Ischemic Stroke |
| Date of disclosure of the study information | 2009/08/14 |
| Last modified on | 2009/08/13 16:48:37 |
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Basic information
Public title
Clinical research on a neuroprotective effect of minocycline treatment in the acute stage of Ischemic Stroke
Acronym
Japan Minocycline Treatment in Acute Ischemic Stroke (JMTAIS)
Scientific Title
Clinical research on a neuroprotective effect of minocycline treatment in the acute stage of Ischemic Stroke
Scientific Title:Acronym
Japan Minocycline Treatment in Acute Ischemic Stroke (JMTAIS)
Region
| Japan |
Condition
Condition
Brain Infarction
Classification by specialty
| Neurology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the prognosis will improve or not by using Minocycline in the acute stage of Ischemic Stroke patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of NIH Stroke Scale (NIHSS) scores on day 90 in subjects treated with 200 mg/day minocycline vs placebo.
Key secondary outcomes
Comparison of NIH Stroke Scale (NIHSS) scores on day 7 and day 30, as well as modified Rankin Scale (mRS) and Barthel Index (BI) scores on day 7, day 30, and day 90.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
200 mg/day of Minocycline for 5 consecutive days
Interventions/Control_2
Placebo for 5 consecutive days
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age >= 20
2) NIHSS Score >= 4
3) Ischemic Stroke patients within 6 to 24 hours from the onset and oral administration is available within the hours
Key exclusion criteria
1) Hemorrhagic Stroke patients
2) Patients with evidence of other disease of the CNS
3) JCS >= 10
4) mRS before the onset >= grade 3
5) Patients who have known allergic response to tetracyclines
6) Patients with serious liver or renal diseases
7) Patients who have swallowing difficulties
8) During pregnancy or lactation
9) Patients who have serious pre-existing diseases
10) Patients who weigh over 100 kg
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Takahashi |
Organization
National Hospital Organization, Kumamoto Medical Center
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
1-5 Ninomaru, Kumamoto, 860-0008, Japan
TEL
096-353-6501
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Takahashi |
Organization
National Hospital Organization, Kumamoto Medical Center
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
1-5 Ninomaru, Kumamoto, 860-0008, Japan
TEL
096-353-6501
Homepage URL
t99@kumamoto2.hosp.go.jp
Sponsor or person
Institute
Takeshi Takahashi
Institute
Department
Personal name
Funding Source
Organization
Ministry of health, labour and welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 08 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Preinitiation
Date of protocol fixation
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | 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
| 2009 | Year | 08 | Month | 13 | Day |
Last modified on
| 2009 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002852
