UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024270 |
|---|---|
| Receipt number | R000027932 |
| Scientific Title | study of everolimus for autistic spectrum disorder in tuberous sclerosis |
| Date of disclosure of the study information | 2016/10/03 |
| Last modified on | 2018/10/09 10:54:52 |
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Basic information
Public title
study of everolimus for autistic spectrum disorder in tuberous sclerosis
Acronym
study of everolimus for ASD in TS
Scientific Title
study of everolimus for autistic spectrum disorder in tuberous sclerosis
Scientific Title:Acronym
study of everolimus for ASD in TS
Region
| Japan |
Condition
Condition
tuberous sclerosis
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of everolimus for autistic spectrum disorder in tuberous sclerosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
scale score for autistic spectrum disorder in 24 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
off-label use
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
| 5 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
tuberous sclerosis with ASD symptons
tuberous sclerosis with subependymal giant astrocytoma
Key exclusion criteria
severe mental retardation
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuyuki Ohto |
Organization
University of Tsukuba
Division name
Pediatrics
Zip code
Address
1-1-1, Tennodai, Tsukuba, Ibaraki
TEL
029-853-3210
tohto@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuyuki Ohto |
Organization
University of Tsukuba
Division name
Pediatrics
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3210
Homepage URL
tohto@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2016 | Year | 10 | Month | 03 | 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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 03 | Day |
Last modified on
| 2018 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027932
