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

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ClinicalTrials.gov Identifier: NCT02920060
Recruitment Status : Completed
First Posted : September 30, 2016
Last Update Posted : September 30, 2016
Sponsor:
Collaborator:
Institute of Medical Sciences of the Banaras Hindu University (BHU),India
Information provided by (Responsible Party):
Dr. Astha Panghal, Banaras Hindu University

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.

Condition or disease Intervention/treatment Phase
Grand Mal Status Epilepticus Drug: Intravenous levetiracetam Drug: Sodium valproate Phase 2

Detailed Description:

In our study patients were considered to have RSE if children were still having active convulsions despite receiving injection lorazepam intravenously at a dose of 0.1 mg/kg (max 4 mg) at a rate maximum upto 2 mg/min or intravenous diazepam at a dose of 0.2 - 0.3 mg/Kg (maximum 10 mg) slowly or intravenous midazolam at a dose of 0.15 - 0.2 mg/kg(max 5 mg). In case of children with difficult intravenous access buccal/nasal midazolam 0.2 - 0.3 mg/kg (maximum 5 mg) per rectal diazepam 0.5 mg/kg (maximum 10 mg) or intramuscular midazolam 0.2 mg/kg (maximum 5 mg). If seizure continued at 5 minutes, a repeat dose of benzodiazepine was given with same dose. At 10 minutes, if the seizure activity still remains intravenous phenytoin was given at a dose of 20mg/kg(maximum- 1000mg) at a rate of 1mg/kg/minute or intravenous fosphenytoin at 20mg PE/kg (if available) at a rate of 3mg PE/kg/minute.

Patients having seizure activity despite administration of above medications were considered to have RSE. Out of thousands of patients seen in outdoor and emergency ward, 80 patients were diagnosed to have RSE and met the inclusion criteria. After counselling the parents/guardians about the medications and obtaining a written informed consent they were randomized to into two groups : sodium valproate(V) and levetiracetam group(L), using a computer generated randomization chart. Forty patients in group V received intravenous valproic acid in dose of 20 mg/kg as loading dose at a rate of 40 mg/min after dilution with normal saline followed by maintenance dose of 10mg/kg/dose 8 hourly. In group L patients received intravenous levetiracetam as loading dose of 30 mg/kg at a rate of 50 mg/min followed by 20mg/kg/dose 12 hourly.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus : An Open Randomized Study
Study Start Date : January 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016


Arm Intervention/treatment
Experimental: Levetiracetam
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
intravenous levetiracetam(30mg/kg bolus followed by 20mg/kg/dose IV 12 hourly).
Other Name: injection Levera

Active Comparator: Sodium valproate
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
intravenous sodium valproate(20mg/kg bolus followed by 10 mg/kg/dose IV 8hrly)
Other Name: injection Encorate




Primary Outcome Measures :
  1. cessation of convulsions (clinically evident motor activity) [ Time Frame: 30 minutes ]
    clinical cessation of convulsions, vitals monitoring


Secondary Outcome Measures :
  1. seizure activity at 24 hours of infusion [ Time Frame: 24 hours ]
    whether clinical convulsive activity cessation or not

  2. seizure recurrence [ Time Frame: 24 hours ]
    average number of seizure recurring after drug infusion within 24 hours

  3. additional number of drugs [ Time Frame: 24 hours ]
    number of additional drugs to control RSE within 24 hours of infusion

  4. time taken to control seizure activity [ Time Frame: 24 hours ]
    time needed to control convulsive activity from infusion time

  5. change in vital parameters after infusing interventional agent [ Time Frame: 24 hours ]
    vital parameters will be recorded every 15 minutes for the first 1 hour after the intervention began and mean value of vital parameters will be compared in two groups

  6. neurological outcome and seizure control [ Time Frame: 1 month ]
    to look for any neurological deficit or behavioural abnormality and seizure control at one month of follow-up



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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920060


Sponsors and Collaborators
Banaras Hindu University
Institute of Medical Sciences of the Banaras Hindu University (BHU),India
Investigators
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Study Director: Rajniti Prasad, MD Banaras Hindu University

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Responsible Party: Dr. Astha Panghal, Pricipal investigator, Banaras Hindu University
ClinicalTrials.gov Identifier: NCT02920060     History of Changes
Other Study ID Numbers: ECR/526/Inst/UP/2014
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Astha Panghal, Banaras Hindu University:
RSE
Additional relevant MeSH terms:
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Levetiracetam
Status Epilepticus
Seizures
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Valproic Acid
Anticonvulsants
Nootropic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs