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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001284
Receipt No. 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

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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
Email

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
Email sonoko.m@mb.infoweb.ne.jp

Sponsor
Institute Chiba University Graduate School of Medicine, Department of Neurology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001565

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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