UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021218 |
|---|---|
| Receipt number | R000024471 |
| Scientific Title | Evaluation of iron chelator administration, and cochlear implantation for s uperficial siderosis (ECHACISS) |
| Date of disclosure of the study information | 2016/02/26 |
| Last modified on | 2024/10/26 14:37:14 |
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Basic information
Public title
Evaluation of iron chelator administration, and cochlear implantation for s
uperficial siderosis (ECHACISS)
Acronym
Evaluation of iron chelator administration, and cochlear implantation for s
uperficial siderosis (ECHACISS)
Scientific Title
Evaluation of iron chelator administration, and cochlear implantation for s
uperficial siderosis (ECHACISS)
Scientific Title:Acronym
Evaluation of iron chelator administration, and cochlear implantation for s
uperficial siderosis (ECHACISS)
Region
| Japan |
Condition
Condition
superficial siderosis of CNS
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of an efficacy of iron chelator (deferripron) and cochlear implantation to the symptoms of superficial siderosis of the central nervous system
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
hearing ability, cerebellar ataxia (SARA, ICARS), MRI findings, pyramidal sign, electrophysiological studies
Key secondary outcomes
persistence rate of treatment, CSF findings, safety
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
deferiprone administration
cochlear implantation
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients diagnosed as having superficial siderosis of CNS
Key exclusion criteria
anaphylaxis to iron chelator
patients receiving any drug having side effect of leukopenia
pregnant person
claustrophobia
inadequate patients
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Sanjo |
Organization
Institute of Science Tokyo Hospial
Division name
Department of Neurology and Neurological Science
Zip code
1138519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5234
n-sanjo.nuro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | same |
| Middle name | |
| Last name | same |
Organization
same
Division name
same
Zip code
same
Address
same
TEL
03-5803-5234
Homepage URL
https://www.tmd.ac.jp/medhospital/medical/disease/shinkei.html
n-sanjo.nuro@tmd.ac.jp
Sponsor or person
Institute
Department of Neurology, Institute of Science Tokyo
Institute
Department
Personal name
non-disclosure
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
Department of Neurology, Kouchi University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo, Clinical Research Ethical Board
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-3813-6111
n-sanjo.nuro@tmd.ac.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
東京医科歯科大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
unreleased
Publication of results
Unpublished
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00415-021-10844-8
Number of participants that the trial has enrolled
35
Results
Conclusions Deferiprone administration significantly improved radiological and clinical outcomes in patients with postoperative
superficial siderosis. Earlier and longer courses of deferiprone could result in better patient prognosis.
Results date posted
| 2022 | Year | 03 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 10 | Month | 18 | Day |
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
SARA
UCARS
MRI
hearing test
MEP
SEP
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 26 | Day |
Last modified on
| 2024 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024471
