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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000014715

Enrollment

100

Registered

2014-08-25

Start date

2019-09-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Contacts

Public ContactMasayuki Shimono

University of Occupational and Environmental Health, Japan Department of Pediatrics

shimono@med.uoeh-u.ac.jp093-603-1611

Outcome results