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NCT Number: NCT04926844

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

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.

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Key information

Conditions

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

Age range

1 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Pediatrics - Sohag University Hospital

Sohag, 82524, Egypt

About this study

Generalized convulsive status epilepticus (GCSE) is a common pediatric neurological emergency with an annual incidence of up to 73 episodes per 100,000 children and is associated with mortality in 2.7% of cases and overall morbidity in 10% - 20% of cases, including hemodynamic instability and long-term neurological impairments.

The management of GCSE in children starts with emergency measures (stabilization phase) with monitoring and laboratory testing in the first 5 minutes. Benzodiazepines are used as first-line anticonvulsants for GCSE that persists for more than 5 minutes. However, studies have shown that benzo-diazepines don't control GCSE in about 30% of patients. GCSE may be more rapidly stopped and controlled through combining another drug with benzodiazepines, acting by different pathways.

Levetiracetam is a recent broad-spectrum antiepileptic drug with a relatively high safety profile. The effectiveness of intravenous levetiracetam has been demonstrated as a second-line anticonvulsant in GCSE. In this study, we aim to evaluate the effectiveness and safety of levetiracetam plus midazolam versus midazolam alone as first-line therapy of GCSE in children.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Generalized convulsive status epilepticus, which is clinically defined at the time of presentation as continuous, generalized, tonic-clonic seizure activity or ≥ 2 generalized tonic-clonic seizures without recovery of consciousness for more than 5 minutes.

Exclusion criteria

  • Failure to obtain informed consent.
  • Prior therapy with any anticonvulsant for the presenting episode of generalized convulsive status epilepticus.
  • Epileptic patients on levetiracetam therapy.
  • Known allergy or contraindications to any of the study drugs.
  • End-stage kidney disease.
  • Severe liver disease.
  • Cardiac diseases.
  • Hypoglycemia or hyperglycemia.
  • Inborn errors of metabolism.
  • Known mood/behavioral disorder.
  • Failure to obtain intravenous access in the first 5 minutes.
  • Cessation of seizures during the stabilization phase (0 - 5 minutes).
  • Traumatic brain injury

Treatment and study plan

Levetiracetam

Drug

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

Other names: Keppra, Tiratam

midazolam

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Cessation of seizures

    Time frame: 20 minutes

    Cessation of clinical seizures at 20 minutes timepoint (end of first therapy phase)

Secondary outcomes

  1. Need for repeating midazolam

    Time frame: 20 minutes

    Need for repeating midazolam during the first therapy phase (5 - 20 min)

  2. Cessation of seizures

    Time frame: 40 minutes

    Cessation of clinical seizures at 40 minutes timepoint (end of second therapy phase).

  3. Seizure control

    Time frame: 24 hours

    24-hours seizure control (no visually observed recurrence of seizures after the end of second phase therapy with improved sensorium)

  4. Hypotension

    Time frame: 24 hours

    Occurrence of hypotension

  5. Need for mechanical ventilation

    Time frame: 24 hours

    Need for mechanical ventilation

  6. Skin rash

    Time frame: 24 hours

    Occurrence of skin rash

  7. Agitation/aggression

    Time frame: 24 hours

    Occurrence of agitation/aggression

  8. Mortality

    Time frame: 24 hours

    Occurrence of death

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 15, 2021
Registry last updated
Sep 21, 2022

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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