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CompletedNCT07052136Updated Jul 4, 2025

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

An interventional study of Levetiracetam and Valproic acid in Status Epilepticus, sponsored by RESnTEC, Institute of Research. Completed at 1 site in Pakistan. Open to participants aged 2 Years to 14 Years. Per ClinicalTrials.gov, last updated 2025-07-04.

Sponsored by RESnTEC, Institute of Research · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Nov 2024, registered Jun 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
138
Allocation
Randomized
Ages
2 Years to 14 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Status Epilepticus

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03

In context

Status Epilepticus

126 studies on the registry are indexed under Status Epilepticus; 37 are open to participants now.

This study's enrollment of 138 is above the median of 70 across 74 interventional studies indexed under Status Epilepticus.

Browse Status Epilepticus studies →

Lead sponsor

RESnTEC, Institute of Research is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
138 participants (actual)

Study arms

  • Experimental
    Levetiracetam group

    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

  • Experimental
    Valproic acid group

    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

  • DrugLevetiracetam

    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.

  • DrugValproic acid

    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.

06

What researchers measure

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

    Time frame: 24 hours

Secondary outcomes

  1. Immediate cessation of seizure activity

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

    Time frame: 30 minutes

07

Study locations

1 site
  • Nishtar University Hospital
    Multan, Punjab Province 66000, Pakistan
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References and documents

Individual participant data

Plan to share: No — Data can be shared on a reasonable request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07052136
Lead sponsor
RESnTEC, Institute of Research
Responsible party
Sponsor
First posted
Jul 4, 2025
Start date
Nov 1, 2024
Primary completion
Apr 30, 2025
Completion
Apr 30, 2025
Last update
Jul 4, 2025

Study contacts

Atifa Mazhar
principal investigator · Nishtar University Hospital, Multan
Javaria Rasheed, FCPS
study director · Nishtar University Hospital, Multan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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