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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002332
Receipt No. 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

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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
Email

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
Email t99@kumamoto2.hosp.go.jp

Sponsor
Institute Takeshi Takahashi
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002852

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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