UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036332 |
|---|---|
| Receipt number | R000041396 |
| Scientific Title | Ascorbic acid treatment for Charcot-Marie-Tooth disease type 1A |
| Date of disclosure of the study information | 2019/03/28 |
| Last modified on | 2019/03/28 23:09:25 |
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Basic information
Public title
Ascorbic acid treatment for Charcot-Marie-Tooth disease type 1A
Acronym
Ascorbic acid treatment for CMT1A
Scientific Title
Ascorbic acid treatment for Charcot-Marie-Tooth disease type 1A
Scientific Title:Acronym
Ascorbic acid treatment for CMT1A
Region
| Japan |
Condition
Condition
Charcot-Marie-Tooth diease type 1A
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Inihibition of progressive muscle weakness
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Charcot-Marie-Tooth disease neurological score will be used for primary outcome every 24 weeks after ascorbic acid treatment
Key secondary outcomes
Electrophysiological examination including latency, conduction velocity, temporal dispersion and compund muscle action potential.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ascorbic acid treatment: 20mg/kg/day, dayly
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
| 1 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Genetically Confirmed PMP duplication
2. Normal blood examination
3. Normal urinary analysis
4. Informed consent obtained
Key exclusion criteria
1. Unsuitable patient judged by the medical doctor
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Katsunori |
| Middle name | |
| Last name | Fujii |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-226-2144
kfujii@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Aoyagi |
Organization
Chiba University Hospital
Division name
Department of Clinical Investigation
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-222-7171
Homepage URL
prc-jim@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
043-222-7171
prc-jim@chiba-u.jp
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
| 2019 | Year | 03 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 03 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2034 | Year | 06 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 28 | Day |
Last modified on
| 2019 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041396
