Ketamine and Levetiracetam as Second-line Antiseizure Medication for Status Epilepticus in Children

NCT07046611 | Recruiting Phase 2

• 1 other identifier: Soh-Med-25-6-2PD
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

About 40% of children with generalized convulsive status epilepticus (GCSE) are not terminated by first-line benzodiazepines (BDZs), and approximately 50% of BDZ-refractory GCSE are not controlled by second-line antiseizure medications. This study investigates the efficacy of ketamine-levetiracetam combination vs. levetiracetam alone for treating children with BDZ-refractory GCSE.

Conditions

Generalized Convulsive Status Epilepticus

Outcome Measures

Primary Outcomes (1)

• Number of participants with cessation of seizures at 20-minute

  Number of participants with cessation of clinically evident seizures at 20-minute after starting study drug administration without endotracheal intubation or need for other antiseizure medications or anticonvulsant sedatives

  20 minutes

Secondary Outcomes (10)

• Number of participants with cessation of seizures at 5-minute

  5 minutes

• Number of participants with sustained cessation of seizures

  From 20 minutes to 60 minutes

• Number of participants with recurrence of seizures

  From 20 minutes to 4 hours

• Number of participants underwent endotracheal intubation

  60 minutes

• Number of participants with severe hypotension

  60 minutes

Study Arms (2)

Ketamine + Levetiracetam

EXPERIMENTAL

Drug: Ketamine; Drug: Levetiracetam

Placebo + Levetiracetam

PLACEBO COMPARATOR

Drug: Levetiracetam; Drug: Placebo

Interventions

Ketamine DRUG

Intravenous ketamine (5 mg/ml concentration) 2 mg/kg (max 90 mg) over 2 minutes

Ketamine + Levetiracetam

Levetiracetam DRUG

Intravenous levetiracetam (50 mg/ml concentration) 60 mg/kg (max 4500 mg) over 5 minutes

Ketamine + Levetiracetam; Placebo + Levetiracetam

Placebo DRUG

Intravenous isotonic saline 0.4 mL/kg (maximum 18 mL) over 2 minutes

Placebo + Levetiracetam

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age from 1 year to 16 years.
• Generalized convulsive status epilepticus (GCSE), defined as clinically observed generalized tonic-clonic convulsions that continue or recur without complete regaining of consciousness in between for longer than 5 minutes.
• Benzodiazepine-refractory, defined as continuous or recurrent GCSE in the emergency room after receiving an adequate benzodiazepine dose, with the last dose administered within 5 to 30 minutes.

You may not qualify if:

• Failure to obtain informed consent.
• Prior treatment with antiseizure medication or anticonvulsant sedatives other than benzodiazepines for the presenting GCSE episode.
• Endotracheal intubation before enrollment.
• Acute traumatic brain injury.
• Cardiac arrest/post-anoxic seizures
• Hypoglycemia or hyperglycemia.
• Known allergies or contraindications to ketamine or levetiracetam
• Failure to obtain intravenous access.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Department of Pediatrics at Sohag University Hospital

Sohag, 82524, Egypt

RECRUITING

MeSH Terms

Conditions

Status Epilepticus

Interventions

Ketamine; Levetiracetam

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetamides; Amides; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Elsayed Abdelkreem, MD, PhD

CONTACT

1114232126; d.elsayedmohammed@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 1, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)