CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 144 enrolled
Drug / intervention
Levetiracetam +2 moredrug
Likely dose
Levetiracetam 60 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04926844
NCT04926844Phase 2Completed

Effectiveness of Combined Levetiracetam and Midazolam in Treatment of Generalized Convulsive Status Epilepticus in Children

Sohag University·interventional·Posted Jun 15, 2021·Updated Sep 21, 2022

In Brief

A Phase 2 clinical trial evaluating Levetiracetam, Midazolam, and 1 other intervention for Status Epilepticus and 3 related conditions. Completed, enrolled 144 participants across 1 site.

Detailed Summary

Generalized status epilepticus is a common pediatric neurological emergency with significant mortality and morbidity. Benzodiazepines remain the first anticonvulsive line but benzo-diazepines don't control seizures in about 30% of cases. GCSE may be more rapidly stopped and controlled through combining another drug with benzodiazepines such as Levetiracetam, acting by different pathways. This study aims to evaluate the effectiveness of combined levetiracetam and midazolam in treatment of generalized convulsive status epilepticus in children.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJun 15, 2021
Enrollment StartJun 20, 2021
Primary CompletionAug 30, 2022
Study CompletionSep 1, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.0 years ago

Interventions

Levetiracetamdrug

Intravenous levetiracetam 60 mg/kg (max 4500 mg) over 5 minutes (diluted with isotonic saline to a concentration of 50 mg/ml).

Midazolamdrug

Intravenous midazolam 0.2 mg/kg (maximum 10 mg) over 2 minutes

Placebodrug

Intravenous isotonic saline (1.2 ml/kg) over 5 minutes