Grand Mal Status EpilepticusPhase 2NCT02920060
Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus
A Phase 2 study testing Intravenous levetiracetam and Sodium valproate in people with Grand Mal Status Epilepticus, run by Banaras Hindu University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Grand Mal Status Epilepticus
- What is being tested?
- Intravenous levetiracetam and Sodium valproate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus : An Open Randomized Study
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.
Read the 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.
- Conditions
- Grand Mal Status Epilepticus
- Being tested
- Intravenous levetiracetam, Sodium valproate
- Keywords
- RSE
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous levetiracetamDrug
Also called injection Levera
intravenous levetiracetam(30mg/kg bolus followed by 20mg/kg/dose IV 12 hourly).
Sodium valproateDrug
Also called injection Encorate
intravenous sodium valproate(20mg/kg bolus followed by 10 mg/kg/dose IV 8hrly)
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Experimental | patient in this group will receive intravenous levetiracetam as loading dose of 30 mg/kg at a rate of 50 mg/min Receives: 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 Receives: Drug: Sodium valproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
cessation of convulsions (clinically evident motor activity)
clinical cessation of convulsions, vitals monitoring
Measured: 30 minutes
Secondary outcomes (6)
seizure activity at 24 hours of infusion
whether clinical convulsive activity cessation or not
Measured: 24 hours
seizure recurrence
average number of seizure recurring after drug infusion within 24 hours
Measured: 24 hours
additional number of drugs
number of additional drugs to control RSE within 24 hours of infusion
Measured: 24 hours
time taken to control seizure activity
time needed to control convulsive activity from infusion time
Measured: 24 hours
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
Measured: 24 hours
neurological outcome and seizure control
to look for any neurological deficit or behavioural abnormality and seizure control at one month of follow-up
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grand Mal Status EpilepticusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banaras Hindu University
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Medical Sciences of the Banaras Hindu University, India
- Responsible party
- Principal investigator, Dr. Astha Panghal, Banaras Hindu University
- Investigators
- Rajniti Prasad, MD, Study director, Banaras Hindu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920060
- Sponsor's protocol ID
- ECR/526/Inst/UP/2014
- Status last verified
- Sep 2016
- First submitted
- 24 Sep 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus : An Open Randomized Study
- ClinicalTrials.gov ID
- NCT02920060
- Acronym / sponsor ID
- ECR/526/Inst/UP/2014
- Conditions
- Grand Mal Status Epilepticus
- Keywords
- RSE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Banaras Hindu UniversityUniversity, hospital or other
- Collaborators
- Institute of Medical Sciences of the Banaras Hindu University, India
- Study start
- Jan 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | Experimental | Drug: Intravenous levetiracetampatient in this group will receive intravenous levetiracetam as loading dose of 30 mg/kg at a rate of 50 mg/min |
| Sodium valproate | Active comparator | Drug: Sodium valproatepatients in this group will receive intravenous sodium valproate 20 mg/kg as loading dose at a rate of 40 mg/min |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous levetiracetamAlso: injection Leveraintravenous levetiracetam(30mg/kg bolus followed by 20mg/kg/dose IV 12 hourly). | Drug | Levetiracetam |
| Sodium valproateAlso: injection Encorateintravenous sodium valproate(20mg/kg bolus followed by 10 mg/kg/dose IV 8hrly) | Drug | Sodium valproate |
Primary outcome
cessation of convulsions (clinically evident motor activity)
Time frame: 30 minutes
clinical cessation of convulsions, vitals monitoring
6 secondary outcomes
seizure activity at 24 hours of infusion
Time frame: 24 hours
seizure recurrence
Time frame: 24 hours
additional number of drugs
Time frame: 24 hours
time taken to control seizure activity
Time frame: 24 hours
change in vital parameters after infusing interventional agent
Time frame: 24 hours
neurological outcome and seizure control
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajniti Prasad, MD study director
Banaras Hindu University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous levetiracetam and Sodium valproate in people with Grand Mal Status Epilepticus, run by Banaras Hindu University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cessation of convulsions (clinically evident motor activity) (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016; AzTrials last refreshed its copy on 6 Nov 2026.