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Completed

NCT Number: NCT07052136

Efficacy Comparison Between Levetiracetam and Valproic Acid in Pediatric Patients With Status Epilepticus

Since there is a significant degree of variability in the results of previous studies and there exists a thirst for local data regarding this topic, the current study was planned, with the objective of comparing the efficacy of levetiracetam versus valproic acid in pediatric patients with status epilepticus.

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Key information

Conditions

Status Epilepticus Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nishtar University Hospital

Multan, Punjab Province, 66000, Pakistan

About this study

Early and sustained control of seizures is paramount in status epilepticus to save the life of the patient, and this warrants the use of the best drug based on evidence. Identifying a better drug in status epilepticus would add to the local data and help clinicians in making evidence-based decisions to opt for an appropriate treatment in case of failed response to benzodiazepines.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any gender
  • Aged 2-14 years
  • Presenting with status epilepticus

Exclusion criteria

  • Patients with focal seizures
  • Patients already using valproic acid or levetiracetam
  • Patients with a history of hypersensitivity to either drug

Treatment and study plan

Levetiracetam

Drug

Patients were treated with intravenous levetiracetam (LEV) 20 mg/kg over 15 minutes, followed by 60 mg/kg/day in two divided doses over 24 hours.

Valproic acid

Drug

Patients received intravenous valproic acid at 15 mg/kg over 15 minutes, followed by 20 mg/kg/day in two divided doses over 24 hours.

Primary outcomes

  1. Sustained control of seizure activity

    Time frame: 24 hours

    Sustained control was labeled when there was no seizure activity on EEG and regain of consciousness for ≥ 24 hours

Secondary outcomes

  1. Immediate cessation of seizure activity

    Time frame: 30 minutes

    Immediate cessation was defined as cessation of seizure activity within 15-30 minutes, after completion of drug infusion.

Sponsors and collaborators

Lead sponsor

RESnTEC, Institute of Research

Other

Registry information

Official study title

Comparison Between Efficacy of Levetiracetam Versus Valproic Acid in Pediatric Patients With Status Epilepticus

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 4, 2025
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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