Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus

NCT02920060 | Completed Phase 2

• 1 other identifier: ECR/526/Inst/UP/2014
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a randomized, open label, parallel group,comparing the safety and efficacy of valproate and levetiracetam in patients of age group 1 to 16 years with status epilepticus not responded to phenytoin and benzodiazepines approaching to pediatric emergency , IMS, BHU. The primary outcome measures will be Proportion of children in either group who have Cessation of all clinical seizure within 30 min of drug administration and secondary outcome will be time taken to control seizure (minutes) from the initiation of infusion. Proportion of children in either group who required additional drugs to abort ongoing clinical seizures, rates of adverse events (hypotension, bradycardia, respiratory depression, PICU stay, in hospital mortality) in the two groups were measured. Refractory status epilepticus condition is major pediatric neurological emergency with high mortality and morbidity. Till now, the treatment guidelines for it are based primarily on retrospective studies with very few randomized studies. There is lack of sufficient data to recommend one drug over another for treatment of refractory status epilepticus.

Conditions

Grand Mal Status Epilepticus

Keywords

RSE

Outcome Measures

Primary Outcomes (1)

• cessation of convulsions (clinically evident motor activity)

  clinical cessation of convulsions, vitals monitoring

  30 minutes

Secondary Outcomes (6)

• seizure activity at 24 hours of infusion

  24 hours

• seizure recurrence

  24 hours

• additional number of drugs

  24 hours

• time taken to control seizure activity

  24 hours

• change in vital parameters after infusing interventional agent

  24 hours

Study Arms (2)

Levetiracetam

EXPERIMENTAL

patient in this group will receive intravenous levetiracetam as loading dose of 30 mg/kg at a rate of 50 mg/min

Drug: Intravenous levetiracetam

Sodium valproate

ACTIVE COMPARATOR

patients in this group will receive intravenous sodium valproate 20 mg/kg as loading dose at a rate of 40 mg/min

Drug: Sodium valproate

Interventions

Intravenous levetiracetam DRUG

intravenous levetiracetam(30mg/kg bolus followed by 20mg/kg/dose IV 12 hourly).

Also known as: injection Levera

Levetiracetam

Sodium valproate DRUG

intravenous sodium valproate(20mg/kg bolus followed by 10 mg/kg/dose IV 8hrly)

Also known as: injection Encorate

Sodium valproate

Eligibility Criteria

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

You may qualify if:

• Age - 1 year to 16 years
• Gender - male and female both
• Refractory generalized convulsive status epilepticus i.e. not responding to any two of the first line drugs

You may not qualify if:

• Patients with epilepsia partialis continua.
• Patients with definite history of any allergic reaction to intravenous levetiracetam or intravenous valproate, or any contraindications in giving these drugs.

Sponsors & Collaborators

• Banaras Hindu University: lead
• Institute of Medical Sciences of the Banaras Hindu University, India: collaborator

MeSH Terms

Conditions

Status Epilepticus

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Rajniti Prasad, MD

  Banaras Hindu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pricipal investigator

Study Record Dates

• First Submitted: September 24, 2016
• First Posted: September 30, 2016
• Study Start: January 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 30, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share