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

NCT04926844 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2022-09-21

No results posted yet for this study

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.

Conditions

  • Status Epilepticus
  • Generalized Convulsive Status Epilepticus
  • Status Epilepticus, Generalized
  • Status Epilepticus, Generalized Convulsive

Interventions

DRUG

Levetiracetam

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

DRUG

Midazolam

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Principal Investigators

  • Abdelrahim A Sadek, MD, PhD · Sohag University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-20
Primary Completion
2022-08-30
Completion
2022-09-01

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04926844 on ClinicalTrials.gov