UMIN-CTR Clinical Trial

Public title

Decreasing and Changing the Types and Quantities of Oral Antiepileptic: Intravenous Antiepileptic Drug as a Base Therapy.

Acronym

Oral Antiepileptic adjustment with Intravenous Antiepileptic Drug.

Scientific Title

Decreasing and Changing the Types and Quantities of Oral Antiepileptic: Intravenous Antiepileptic Drug as a Base Therapy.

Scientific Title:Acronym

Oral Antiepileptic adjustment with Intravenous Antiepileptic Drug.

Region

Japan

Condition

Intractable epileptic patients who are taking two or more kinds of appropriate antiepileptic drugs

Classification by specialty

Neurology

Pediatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We examine whether we reduce the number and/or dose of oral AEDs for the intractable epileptic patients to exchange them to newer ones with IV AED as a base drug.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

After a year for drug adjustment, we estimate following; 1) the number of oral drugs patients used before and after drug adjustment, 2)the frequency of seizures before and after drug adjustment, 3) adverse events from the use of an IV AED while we withdrew several oral AEDs at one time, 4) adverse events that occurred at least for 1 year follow-up periods, and 5) the length of stay in our hospital for drug adjustment.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

1

years-old

<=

Age-upper limit

20

years-old

>=

Gender

Male and Female

Key inclusion criteria

The epileptic patients who are taking two or more kinds of appropriate antiepileptic drugs but have seizurse to spoil their quority of life, and whose EEG improve after the administration of an IV AED or whose clinical symptoms are not exacerbated, include this study. We did not register our work before enrolling the participants because we thought this work was not a clinical trial but a clinical treatment. So, this is the retrospective study. We acquired written informed consent about methods of trial and follow-up schedule from the patients and/or one of their parents. Therefore, we registered these contents on the Hospital Ethics Committee of Medicine and Medical care, University of Occupational and Environmental Health, JAPAN at August 1st, 2014 (Registration No. 2014-08). The Hospital Ethics Committee of Medicine and Medical care, University of Occupational and Environmental Health, JAPAN cannot admit our study as a clinical trial, but the Ethics Committee allowed us to use the data as a clinical treatment (from October 1st, 2010 to June 30th, 2013). We also register our work to the Japan Primary Registries Network.

Key exclusion criteria

The epileptic patients whose EEG did not improve after the administration of any IV AED or whose clinical symptoms were exacerbated are excluded from this study.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Masayuki Shimono

Organization

School of Medicine, University of Occupational and Environmental Health, Japan

Division name

Department of Pediatrics

Zip code

Address

Iseigaoka 1-1, Yahatanishi, Kitakyushu 807-8555, Japan.

TEL

093-603-1611

Email

shimono@med.uoeh-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Masayuki Shimono

Organization

University of Occupational and Environmental Health, Japan

Division name

Department of Pediatrics

Zip code

Address

Iseigaoka 1-1, Yahatanishi, Kitakyushu 807-8555, Japan.

TEL

093-603-1611

Homepage URL

Email

shimono@med.uoeh-u.ac.jp

Institute

the Hospital Ethics Committee of Medicine and Medical care, University of Occupational and Environmental Health, JAPAN

Institute

Department

Personal name

Organization

Institution of ethics committee, University of Occupational and Environmental Health, Japan.

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

産業医科大学小児科

Date of disclosure of the study information

2014

Year

08

Month

25

Day

URL releasing protocol

Publication of results

Partially published

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

Recruitment status

Terminated

Date of protocol fixation

2010

Year

10

Month

01

Day

Date of IRB

2019

Year

10

Month

18

Day

Anticipated trial start date

2019

Year

09

Month

30

Day

Last follow-up date

2019

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

We had already finished our trial in 2019.

Registered date

2014

Year

07

Month

30

Day

Last modified on

2023

Year

08

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017104