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

NCT07052136 | Completed

• 1 other identifier: DRATIFA-NISHTER
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Status Epilepticus

Outcome Measures

Primary Outcomes (1)

• Sustained control of seizure activity

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

  24 hours

Secondary Outcomes (1)

• Immediate cessation of seizure activity

  30 minutes

Study Arms (2)

Levetiracetam group

EXPERIMENTAL

In this group, 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.

Drug: Levetiracetam

Valproic acid group

EXPERIMENTAL

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.

Drug: Valproic acid

Interventions

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.

Levetiracetam group

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.

Valproic acid group

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• RESnTEC, Institute of Research: lead

Study Sites (1)

Nishtar University Hospital

Multan, Punjab Province, 66000, Pakistan

Location

MeSH Terms

Conditions

Status Epilepticus

Interventions

Levetiracetam; Valproic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pentanoic Acids; Valerates; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Atifa Mazhar

  Nishtar University Hospital, Multan

  PRINCIPAL INVESTIGATOR

• Javaria Rasheed, FCPS

  Nishtar University Hospital, Multan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: November 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)