UMIN-CTR Clinical Trial

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