Status EpilepticusNCT07163572
Comparison of Intravenous Brivaracetam Versus Levetiracetam in the Management of Status Epilepticus
A study testing Intravenous brivaracetam and Intravenous levetiracetam in people with Status Epilepticus, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
Brivaracetam is increasingly being studied in adult status epilepticus populations, evidence in pediatric patients remains sparse, with only limited case series and observational studies reporting favorable outcomes. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Status Epilepticus
- What is being tested?
- Intravenous brivaracetam and Intravenous levetiracetam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Jan 2025to 16 Aug 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 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Either gender
- Aged one month to 16 years
- Presenting with status epilepticus
Who cannot join
- Previously received intravenous antiseizure medication for the current episode prior to presentation
- Known hypersensitivity to study drugs
- Hemodynamically unstable, requiring inotropic support before administration
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The Children's Hospital and Institute of Child Health
Multan, Punjab Province, 66000
About this study
Official title: Safety and Efficacy of Intravenous Brivaracetam Versus Levetiracetam in the Management of Status Epilepticus in Children
Brivaracetam is increasingly being studied in adult status epilepticus populations, evidence in pediatric patients remains sparse, with only limited case series and observational studies reporting favorable outcomes. This study aims at direct comparison between intravenous brivaracetam and levetiracetam in the acute management of pediatric status epilepticus.
Read the detailed description
Given the urgent need for safe and effective alternatives in pediatric status epilepticus and the limited head-to-head data comparing intravenous brivaracetam with levetiracetam, especially in children, this study has been designed to evaluate their relative safety and efficacy. The research seeks to generate evidence that may help guide clinical decision-making and optimize outcomes in this vulnerable population.
- Conditions
- Status Epilepticus
- Being tested
- Intravenous brivaracetam, Intravenous levetiracetam
- 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 brivaracetamDrug
Patients received intravenous brivaracetam as a loading dose of 2 mg/kg (maximum 100 mg) diluted in 100 ml of normal saline infused over 10 minutes.
Intravenous levetiracetamDrug
Patients received intravenous levetiracetam as a loading dose of 40 mg/kg (maximum 3000 mg) diluted in 100 ml of normal saline infused over 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Brivaracetam group | Experimental | Patients received brivaracetam as a loading dose of 2 mg/kg (maximum 100 mg) diluted in 100 ml of normal saline infused over 10 minutes. Receives: Drug: Intravenous brivaracetam |
| Levetiracetam group | Experimental | Patients received levetiracetam as a loading dose of 40 mg/kg (maximum 3000 mg) diluted in 100 ml of normal saline infused over 10 minutes. Receives: Drug: Intravenous levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cessation of seizures
Cessation of seizures was labeled "yes" if cessation of clinical seizures occurred within 20-30 minutes of infusion without the need for additional antiseizure medication.
Measured: 30 minutes
Secondary outcomes (1)
Adverse Events
Labeled "yes" if any treatment-related adverse event reported 30 minutes post-infusion.
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start16 Jan 2025
- Primary completion16 Aug 2025
- Study completion16 Aug 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
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Ikram Rahman, Principal investigator, Children's Hospital and institute of Child Health, Multan, PakistanNuzhat Noureen, FCPS, Study director, Children's Hospital and institute of Child Health, Multan, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163572
- Sponsor's protocol ID
- Dr-Ikram-Multan
- Status last verified
- Aug 2025
- First submitted
- 1 Sep 2025
- Last updated
- 9 Sep 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 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intravenous Brivaracetam Versus Levetiracetam in the Management of Status Epilepticus in Children
- ClinicalTrials.gov ID
- NCT07163572
- Acronym / sponsor ID
- Dr-Ikram-Multan
- Conditions
- Status Epilepticus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 16 Aug 2025 (actual)
- Study completion
- 16 Aug 2025 (actual)
- First posted
- 9 Sep 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.
Brivaracetam is increasingly being studied in adult status epilepticus populations, evidence in pediatric patients remains sparse, with only limited case series and observational studies reporting favorable outcomes. This study aims at direct comparison between intravenous brivaracetam and levetiracetam in the acute management of pediatric status epilepticus.
Detailed description
Given the urgent need for safe and effective alternatives in pediatric status epilepticus and the limited head-to-head data comparing intravenous brivaracetam with levetiracetam, especially in children, this study has been designed to evaluate their relative safety and efficacy. The research seeks to generate evidence that may help guide clinical decision-making and optimize outcomes in this vulnerable population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brivaracetam group | Experimental | Drug: Intravenous brivaracetamPatients received brivaracetam as a loading dose of 2 mg/kg (maximum 100 mg) diluted in 100 ml of normal saline infused over 10 minutes. |
| Levetiracetam group | Experimental | Drug: Intravenous levetiracetamPatients received levetiracetam as a loading dose of 40 mg/kg (maximum 3000 mg) diluted in 100 ml of normal saline infused over 10 minutes. |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Either gender
- Aged one month to 16 years
- Presenting with status epilepticus
Key exclusion criteria (3 listed)
- Previously received intravenous antiseizure medication for the current episode prior to presentation
- Known hypersensitivity to study drugs
- Hemodynamically unstable, requiring inotropic support before administration
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 brivaracetamPatients received intravenous brivaracetam as a loading dose of 2 mg/kg (maximum 100 mg) diluted in 100 ml of normal saline infused over 10 minutes. | Drug | Brivaracetam group |
| Intravenous levetiracetamPatients received intravenous levetiracetam as a loading dose of 40 mg/kg (maximum 3000 mg) diluted in 100 ml of normal saline infused over 10 minutes. | Drug | Levetiracetam group |
Primary outcome
Cessation of seizures
Time frame: 30 minutes
Cessation of seizures was labeled "yes" if cessation of clinical seizures occurred within 20-30 minutes of infusion without the need for additional antiseizure medication.
1 secondary outcome
Adverse Events
Time frame: 40 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 9 Sep 2025.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
Related trials for Status Epilepticus
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Predictors of Outcomes of Convulsive Status Epilepticus
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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.
Ikram Rahman principal investigator
Children's Hospital and institute of Child Health, Multan, Pakistan
Nuzhat Noureen, FCPS study director
Children's Hospital and institute of Child Health, Multan, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous brivaracetam and Intravenous levetiracetam in people with Status Epilepticus, run by Muhammad Aamir Latif 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 9 Sep 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?
Cessation of seizures (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 9 Sep 2025.