Status EpilepticusNCT07052136
Efficacy Comparison Between Levetiracetam and Valproic Acid in Pediatric Patients With Status Epilepticus
A study testing Levetiracetam and Valproic acid in people with Status Epilepticus, run by RESnTEC, Institute of Research at 1 site in Pakistan.
Trial summary
Since there is a significant degree of variability in the results of previous studies and there exists a thirst for local data regarding this topic, the current study was planned, with the objective of comparing the efficacy of levetiracetam versus valproic acid in pediatric patients with status epilepticus. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Status Epilepticus
- What is being tested?
- Levetiracetam and Valproic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2024to 30 Apr 2025
- Phase
- Interventional
- 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 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any gender
- Aged 2-14 years
- Presenting with status epilepticus
Who cannot join
- Patients with focal seizures
- Patients already using valproic acid or levetiracetam
- Patients with a history of hypersensitivity to either drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Efficacy of Levetiracetam Versus Valproic Acid in Pediatric Patients With Status Epilepticus
Since there is a significant degree of variability in the results of previous studies and there exists a thirst for local data regarding this topic, the current study was planned, with the objective of comparing the efficacy of levetiracetam versus valproic acid in pediatric patients with status epilepticus.
Read the detailed description
Early and sustained control of seizures is paramount in status epilepticus to save the life of the patient, and this warrants the use of the best drug based on evidence. Identifying a better drug in status epilepticus would add to the local data and help clinicians in making evidence-based decisions to opt for an appropriate treatment in case of failed response to benzodiazepines.
- Conditions
- Status Epilepticus
- Being tested
- Levetiracetam, Valproic acid
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Patients were treated with intravenous levetiracetam (LEV) 20 mg/kg over 15 minutes, followed by 60 mg/kg/day in two divided doses over 24 hours.
Valproic acidDrug
Patients received intravenous valproic acid at 15 mg/kg over 15 minutes, followed by 20 mg/kg/day in two divided doses over 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam group | Experimental | In this group, patients were treated with intravenous levetiracetam (LEV) 20 mg/kg over 15 minutes, followed by 60 mg/kg/day in two divided doses over 24 hours. Receives: Drug: Levetiracetam |
| Valproic acid group | Experimental | Patients received intravenous valproic acid at 15 mg/kg over 15 minutes, followed by 20 mg/kg/day in two divided doses over 24 hours. Receives: Drug: Valproic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained control of seizure activity
Sustained control was labeled when there was no seizure activity on EEG and regain of consciousness for ≥ 24 hours
Measured: 24 hours
Secondary outcomes (1)
Immediate cessation of seizure activity
Immediate cessation was defined as cessation of seizure activity within 15-30 minutes, after completion of drug infusion.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Nov 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- RESnTEC, Institute of Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Atifa Mazhar, Principal investigator, Nishtar University Hospital, MultanJavaria Rasheed, FCPS, Study director, Nishtar University Hospital, Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052136
- Sponsor's protocol ID
- DRATIFA-NISHTER
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Efficacy of Levetiracetam Versus Valproic Acid in Pediatric Patients With Status Epilepticus
- ClinicalTrials.gov ID
- NCT07052136
- Acronym / sponsor ID
- DRATIFA-NISHTER
- Conditions
- Status Epilepticus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- RESnTEC, Institute of ResearchUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 4 Jul 2025 (actual)
- 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.
Since there is a significant degree of variability in the results of previous studies and there exists a thirst for local data regarding this topic, the current study was planned, with the objective of comparing the efficacy of levetiracetam versus valproic acid in pediatric patients with status epilepticus.
Detailed description
Early and sustained control of seizures is paramount in status epilepticus to save the life of the patient, and this warrants the use of the best drug based on evidence. Identifying a better drug in status epilepticus would add to the local data and help clinicians in making evidence-based decisions to opt for an appropriate treatment in case of failed response to benzodiazepines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam group | Experimental | Drug: LevetiracetamIn this group, patients were treated with intravenous levetiracetam (LEV) 20 mg/kg over 15 minutes, followed by 60 mg/kg/day in two divided doses over 24 hours. |
| Valproic acid group | Experimental | Drug: Valproic acidPatients received intravenous valproic acid at 15 mg/kg over 15 minutes, followed by 20 mg/kg/day in two divided doses over 24 hours. |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Any gender
- Aged 2-14 years
- Presenting with status epilepticus
Key exclusion criteria (3 listed)
- Patients with focal seizures
- Patients already using valproic acid or levetiracetam
- Patients with a history of hypersensitivity to either drug
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 |
|---|---|---|
| LevetiracetamPatients were treated with intravenous levetiracetam (LEV) 20 mg/kg over 15 minutes, followed by 60 mg/kg/day in two divided doses over 24 hours. | Drug | Levetiracetam group |
| Valproic acidPatients received intravenous valproic acid at 15 mg/kg over 15 minutes, followed by 20 mg/kg/day in two divided doses over 24 hours. | Drug | Valproic acid group |
Primary outcome
Sustained control of seizure activity
Time frame: 24 hours
Sustained control was labeled when there was no seizure activity on EEG and regain of consciousness for ≥ 24 hours
1 secondary outcome
Immediate cessation of seizure activity
Time frame: 30 minutes
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 4 Jul 2025.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
Related trials for Status Epilepticus
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A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
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Predictors of Outcomes of Convulsive Status Epilepticus
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A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
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Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
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RecruitingPhase 3
Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
Status Epilepticus
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.
Atifa Mazhar principal investigator
Nishtar University Hospital, Multan
Javaria Rasheed, FCPS study director
Nishtar University Hospital, Multan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levetiracetam and Valproic acid in people with Status Epilepticus, run by RESnTEC, Institute of Research at 1 site in Pakistan.
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 3 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 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Sustained control of seizure activity (time frame: 24 hours). 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 4 Jul 2025.