Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus
Primary Purpose
Grand Mal Status Epilepticus
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Intravenous levetiracetam
Sodium valproate
Sponsored by
About this trial
This is an interventional treatment trial for Grand Mal Status Epilepticus focused on measuring RSE
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Levetiracetam
Sodium valproate
Arm Description
patient in this group will receive intravenous levetiracetam as loading dose of 30 mg/kg at a rate of 50 mg/min
patients in this group will receive intravenous sodium valproate 20 mg/kg as loading dose at a rate of 40 mg/min
Outcomes
Primary Outcome Measures
cessation of convulsions (clinically evident motor activity)
clinical cessation of convulsions, vitals monitoring
Secondary Outcome Measures
seizure activity at 24 hours of infusion
whether clinical convulsive activity cessation or not
seizure recurrence
average number of seizure recurring after drug infusion within 24 hours
additional number of drugs
number of additional drugs to control RSE within 24 hours of infusion
time taken to control seizure activity
time needed to control convulsive activity from infusion time
change in vital parameters after infusing interventional agent
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
to look for any neurological deficit or behavioural abnormality and seizure control at one month of follow-up
Full Information
NCT ID
NCT02920060
First Posted
September 24, 2016
Last Updated
September 28, 2016
Sponsor
Banaras Hindu University
Collaborators
Institute of Medical Sciences of the Banaras Hindu University (BHU),India
1. Study Identification
Unique Protocol Identification Number
NCT02920060
Brief Title
Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus
Official Title
Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus : An Open Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Banaras Hindu University
Collaborators
Institute of Medical Sciences of the Banaras Hindu University (BHU),India
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Grand Mal Status Epilepticus
Keywords
RSE
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levetiracetam
Arm Type
Experimental
Arm Description
patient in this group will receive intravenous levetiracetam as loading dose of 30 mg/kg at a rate of 50 mg/min
Arm Title
Sodium valproate
Arm Type
Active Comparator
Arm Description
patients in this group will receive intravenous sodium valproate 20 mg/kg as loading dose at a rate of 40 mg/min
Intervention Type
Drug
Intervention Name(s)
Intravenous levetiracetam
Other Intervention Name(s)
injection Levera
Intervention Description
intravenous levetiracetam(30mg/kg bolus followed by 20mg/kg/dose IV 12 hourly).
Intervention Type
Drug
Intervention Name(s)
Sodium valproate
Other Intervention Name(s)
injection Encorate
Intervention Description
intravenous sodium valproate(20mg/kg bolus followed by 10 mg/kg/dose IV 8hrly)
Primary Outcome Measure Information:
Title
cessation of convulsions (clinically evident motor activity)
Description
clinical cessation of convulsions, vitals monitoring
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
seizure activity at 24 hours of infusion
Description
whether clinical convulsive activity cessation or not
Time Frame
24 hours
Title
seizure recurrence
Description
average number of seizure recurring after drug infusion within 24 hours
Time Frame
24 hours
Title
additional number of drugs
Description
number of additional drugs to control RSE within 24 hours of infusion
Time Frame
24 hours
Title
time taken to control seizure activity
Description
time needed to control convulsive activity from infusion time
Time Frame
24 hours
Title
change in vital parameters after infusing interventional agent
Description
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
Time Frame
24 hours
Title
neurological outcome and seizure control
Description
to look for any neurological deficit or behavioural abnormality and seizure control at one month of follow-up
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajniti Prasad, MD
Organizational Affiliation
Banaras Hindu University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus
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