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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039871
Receipt No. R000045467
Scientific Title Efficacy and safety evaluation of ACTH therapy for developmental and epileptic encephalopathy
Date of disclosure of the study information 2020/05/01
Last modified on 2021/09/18

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Basic information
Public title Is ACTH therapy effective for developmental and epileptic encephalopathy?
Acronym ACTH therapy for DEE
Scientific Title Efficacy and safety evaluation of ACTH therapy for developmental and epileptic encephalopathy
Scientific Title:Acronym ACTH therapy for DEE
Region
Japan

Condition
Condition Developmental and Epileptic Encephalopathy
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate Safety and efficacy of ACTH therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Safety of ACTH therapy
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 months-old <=
Age-upper limit
192 months-old >
Gender Male and Female
Key inclusion criteria 1. Patients who have been treated at department of pediatrics, Hokkaido University Hospital from April, 2003.
2. Patients who have diagnosed as infantile spasms at Hokkaido University Hospital
3. Patients who have treated by ACTH therapy
Key exclusion criteria 1. Patients who have been evaluated as inappropriate candidate by principle investigator
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Hideaki
Middle name
Last name Shiraishi
Organization Hokkaido University Hospital
Division name Department of Pediatrics
Zip code 060-8648
Address North 14, West 5, Kita-ku, Sapporo
TEL 011-716-1161
Email siraisi@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Ueda
Organization Hokkaido University Hospital
Division name Department of Pediatrics
Zip code 060-8648
Address North 14, West 5, Kita-ku, Sapporo
TEL 011-716-1161
Homepage URL
Email yu_ueda@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization Hokkaido University
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 Hokkaido University Clinical Research Review
Address North 14, West 5, Kita-ku, Sapporo
Tel 011-716-1161
Email crjimu@huhp.hokudai.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

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 01 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 Open public recruiting
Date of protocol fixation
2020 Year 05 Month 01 Day
Date of IRB
2020 Year 05 Month 07 Day
Anticipated trial start date
2020 Year 05 Month 01 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 None

Management information
Registered date
2020 Year 03 Month 18 Day
Last modified on
2021 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045467

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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