UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001284 |
|---|---|
| Receipt number | R000001565 |
| Scientific Title | Large doses of methylcobalamin for juvenile muscular atrophy of distal upper extremity |
| Date of disclosure of the study information | 2008/08/02 |
| Last modified on | 2015/11/21 11:50:39 |
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Basic information
Public title
Large doses of methylcobalamin for juvenile muscular atrophy of distal upper extremity
Acronym
Methylcobalamin for juvenile muscular atrophy of distal upper extremity
Scientific Title
Large doses of methylcobalamin for juvenile muscular atrophy of distal upper extremity
Scientific Title:Acronym
Methylcobalamin for juvenile muscular atrophy of distal upper extremity
Region
| Japan |
Condition
Condition
juvenile muscular atrophy of distal upper extremity
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether large doses of methylcobalamin improve amyotrophy in patients with juvenile muscular atrophy of distal upper extremity (Hirayama disease).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Overall Neuropathy Limitations Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
methylcobalamin 25mg/day (Day 1-10)
methylcobalamin 25mg/day, every 4 weeks, 5 cycles
Interventions/Control_2
methylcobalamin 1500 microg/day, 6 months
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
| 15 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with amyotrophy
2) Written informed consent
3) Outpatient
Key exclusion criteria
1) Patients with critical illness
2) Pregnant or lactating woman
3) Within 3 months from other clinical trial
4) Patients who are not appropriate to participate to the trial.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Kuwabara |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
Inohana 1-8-1, Chuo-ku, Chiba
TEL
043-222-7171
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sonoko Misawa |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
Inohana 1-8-1, Chuo-ku, Chiba
TEL
043-222-7171
Homepage URL
sonoko.m@mb.infoweb.ne.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine, Department of Neurology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2008 | Year | 08 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2007 | Year | 10 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | 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
| 2008 | Year | 08 | Month | 01 | Day |
Last modified on
| 2015 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001565
| Research Plan | |
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| 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 |
