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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

Tracking Information
First Submitted Date  ICMJE September 24, 2016
First Posted Date  ICMJE September 30, 2016
Last Update Posted Date September 30, 2016
Study Start Date  ICMJE January 2015
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2016)
cessation of convulsions (clinically evident motor activity) [ Time Frame: 30 minutes ]
clinical cessation of convulsions, vitals monitoring
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2016)
  • seizure activity at 24 hours of infusion [ Time Frame: 24 hours ]
    whether clinical convulsive activity cessation or not
  • seizure recurrence [ Time Frame: 24 hours ]
    average number of seizure recurring after drug infusion within 24 hours
  • additional number of drugs [ Time Frame: 24 hours ]
    number of additional drugs to control RSE within 24 hours of infusion
  • time taken to control seizure activity [ Time Frame: 24 hours ]
    time needed to control convulsive activity from infusion time
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus
Official Title  ICMJE Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus : An Open Randomized Study
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Grand Mal Status Epilepticus
Intervention  ICMJE
  • Drug: Intravenous levetiracetam
    intravenous levetiracetam(30mg/kg bolus followed by 20mg/kg/dose IV 12 hourly).
    Other Name: injection Levera
  • Drug: Sodium valproate
    intravenous sodium valproate(20mg/kg bolus followed by 10 mg/kg/dose IV 8hrly)
    Other Name: injection Encorate
Study Arms  ICMJE
  • Experimental: Levetiracetam
    patient in this group will receive intravenous levetiracetam as loading dose of 30 mg/kg at a rate of 50 mg/min
    Intervention: Drug: Intravenous levetiracetam
  • 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
    Intervention: Drug: Sodium valproate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2016)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02920060
Other Study ID Numbers  ICMJE ECR/526/Inst/UP/2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Astha Panghal, Banaras Hindu University
Study Sponsor  ICMJE Banaras Hindu University
Collaborators  ICMJE Institute of Medical Sciences of the Banaras Hindu University (BHU),India
Investigators  ICMJE
Study Director: Rajniti Prasad, MD Banaras Hindu University
PRS Account Banaras Hindu University
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP