Febrile ConvulsionNCT05860153
Intermittent Levetricetam in Treatment of Febrile Convulsions
A study testing Levetiracetam and Diazepam in people with Febrile Convulsion, run by Assiut University.
Trial summary
The American Academy of Pediatrics (AAP) in 2011 published a clinical practice guideline defining a febrile seizure as "a seizure accompanied by fever (temperature ≥ 100.4°F or 38°C by any method), without central nervous system infection, that occurs in infants and children 6 through 60 months of age." Febrile… Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Febrile Convulsion
- What is being tested?
- Levetiracetam and Diazepam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Aug 2024
- 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 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Included children 6 months to 36 months with febrile seizures after exclusion of CNS infections .
Who cannot join
- Non-febrile seizures
- Head trauma
- CNS infections
- Known metabolic diseases
- Known genetic disorders
- Developmental delay
Trial locations and contacts
No sites are listed yet.
About this study
The American Academy of Pediatrics (AAP) in 2011 published a clinical practice guideline defining a febrile seizure as "a seizure accompanied by fever (temperature ≥ 100.4°F or 38°C by any method), without central nervous system infection, that occurs in infants and children 6 through 60 months of age." Febrile seizures are further classified as simple (generalized in onset, last less than 15 minutes, and do not occur more than once in 24 hours.) or complex (FS duration longer than 15 min, repeated convulsions within the same day, and focal seizure activity or focal findings during the postictal period.).
Read the detailed description
The American Academy of Pediatrics (AAP) in 2011 published a clinical practice guideline defining a febrile seizure as "a seizure accompanied by fever (temperature ≥ 100.4°F or 38°C by any method), without central nervous system infection, that occurs in infants and children 6 through 60 months of age." Febrile seizures are further classified as simple (generalized in onset, last less than 15 minutes, and do not occur more than once in 24 hours.) or complex (FS duration longer than 15 min, repeated convulsions within the same day, and focal seizure activity or focal findings during the postictal period.).
Epidemiology Approximately 8% of people will experience at least one seizure episode during their lifetime. Up to 30% of such episodes are febrile seizures (FS), which are the most commonly occurring seizures in 2 to 5% of all children. Nevertheless, although FS is a benign condition in most cases and the prognosis is good generally and recurrences do not impair the prognosis in children who were neurologically normal before their first febrile seizure, FS episodes constitute a traumatic experience, it is a very frightening event for the parents/caregivers witnessing a tonic-clonic seizure, especially for the patients with frequent FS, they suffer extreme anxiety for recurrences of seizures or development of epilepsy; FS is also likely one of the most frequent causes of admittance to pediatric emergency ward worldwide. In any case, febrile seizures should be taken under serious consideration.
During seventies ten eligible clinical trials were included. Prophylaxis with either phenobarbital or diazepam reduces recurrences of febrile seizures.
After oral administration >90% of diazepam is absorbed and the average time to achieve peak plasma concentrations is 1 - 1.5 hours with a range of 0.25 to 2.5 hours. The mean half-life of diazepam has been reported to be 18 hours. Intermittent diazepam in oral or anal form is effective In preventing the recurrence of febrile seizures as diazepam however, the side effects associated with intermittent diazepam in the prevention of febrile seizures outweight it's potential benefits including sedation, behavioral changes, gastrointestinal and hematologic toxicity, hypersensitivity reactions, and rare fatal hepatotoxicity with VPA in young children. And also the intermittent administration of benzodiazepines (e.g., diazepam and midazolam) at the onset of fever is effective, but the effectiveness of this treatment is limited because sedative effects can mask the signs and symptoms of any evolving central nervous system infections.
After oral ingestion, levetiracetam is rapidly absorbed, with peak concentration occurring after 1.3 hours, and its bioavailability is ≥95%. LEV was reported to induce psychotropic side effects in up to 30% of patients. These adverse effects include beneficial effects such as enhancement of drive and cognition on the one hand and behavioral disturbances such as irritability, aggression, agitation, anger, anxiety, apathy, and hostility on the other hand.
- Conditions
- Febrile Convulsion
- Being tested
- Levetiracetam, Diazepam
- Medical subject headings
- Seizures, Febrile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Also called Tiratam
Group with oral levetiracetam at a dose of 15-20 mg/kg/day
DiazepamDrug
Also called Valinil
Group with diazepam at a dose of 0.3 mg/kg/dose
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Experimental | • Group (A) will receive oral levetiracetam at a dose of 15-20 mg/kg/day twice daily at the onset of fever (temperature >37.5 c) for 48h after subsiding of fever. Receives: Drug: Levetiracetam |
| Group (B) | Experimental | • Group (B) will receive diazepam at a dose of 0.3 mg/kg/dose was given every eight hours for 48h after subsiding of fever Children were followed up for 12 months to find out seizure frequency associated with febrile events and febrile seizure recurrence rate during 12 months follow-up Receives: Drug: Diazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of therapeutic effect of oral levetiracetam on febrile convulsions
The rate of therapeutic effect of oral levetiracetam in reducing the recurrence of febrile seizures in children aged 6-36months.
Measured: Baseline
The rate of therapeutic effect of intermittent diazepam on febrile convulsions
The rate of therapeutic effect of intermittent diazepam in reducing the recurrence of febrile seizures in children aged 6-36months.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile ConvulsionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kariman Hussein Tawfik, Assiut University
- Investigators
- Khaled Elsayah, Prof, Principal investigator, Assiut UniversityKhalaf Abd El-Aal, Assist prof, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860153
- Sponsor's protocol ID
- Febrile convulsions treatment
- Status last verified
- May 2023
- First submitted
- 18 Apr 2023
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Levetricetam in Treatment of Febrile Convulsions
- ClinicalTrials.gov ID
- NCT05860153
- Acronym / sponsor ID
- Febrile convulsions treatment
- Conditions
- Febrile Convulsion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 16 May 2023 (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.
The American Academy of Pediatrics (AAP) in 2011 published a clinical practice guideline defining a febrile seizure as "a seizure accompanied by fever (temperature ≥ 100.4°F or 38°C by any method), without central nervous system infection, that occurs in infants and children 6 through 60 months of age." Febrile seizures are further classified as simple (generalized in onset, last less than 15 minutes, and do not occur more than once in 24 hours.) or complex (FS duration longer than 15 min, repeated convulsions within the same day, and focal seizure activity or focal findings during the postictal period.).
Detailed description
The American Academy of Pediatrics (AAP) in 2011 published a clinical practice guideline defining a febrile seizure as "a seizure accompanied by fever (temperature ≥ 100.4°F or 38°C by any method), without central nervous system infection, that occurs in infants and children 6 through 60 months of age." Febrile seizures are further classified as simple (generalized in onset, last less than 15 minutes, and do not occur more than once in 24 hours.) or complex (FS duration longer than 15 min, repeated convulsions within the same day, and focal seizure activity or focal findings during the postictal period.).
Epidemiology Approximately 8% of people will experience at least one seizure episode during their lifetime. Up to 30% of such episodes are febrile seizures (FS), which are the most commonly occurring seizures in 2 to 5% of all children. Nevertheless, although FS is a benign condition in most cases and the prognosis is good generally and recurrences do not impair the prognosis in children who were neurologically normal before their first febrile seizure, FS episodes constitute a traumatic experience, it is a very frightening event for the parents/caregivers witnessing a tonic-clonic seizure, especially for the patients with frequent FS, they suffer extreme anxiety for recurrences of seizures or development of epilepsy; FS is also likely one of the most frequent causes of admittance to pediatric emergency ward worldwide. In any case, febrile seizures should be taken under serious consideration.
During seventies ten eligible clinical trials were included. Prophylaxis with either phenobarbital or diazepam reduces recurrences of febrile seizures.
After oral administration >90% of diazepam is absorbed and the average time to achieve peak plasma concentrations is 1 - 1.5 hours with a range of 0.25 to 2.5 hours. The mean half-life of diazepam has been reported to be 18 hours. Intermittent diazepam in oral or anal form is effective In preventing the recurrence of febrile seizures as diazepam however, the side effects associated with intermittent diazepam in the prevention of febrile seizures outweight it's potential benefits including sedation, behavioral changes, gastrointestinal and hematologic toxicity, hypersensitivity reactions, and rare fatal hepatotoxicity with VPA in young children. And also the intermittent administration of benzodiazepines (e.g., diazepam and midazolam) at the onset of fever is effective, but the effectiveness of this treatment is limited because sedative effects can mask the signs and symptoms of any evolving central nervous system infections.
After oral ingestion, levetiracetam is rapidly absorbed, with peak concentration occurring after 1.3 hours, and its bioavailability is ≥95%. LEV was reported to induce psychotropic side effects in up to 30% of patients. These adverse effects include beneficial effects such as enhancement of drive and cognition on the one hand and behavioral disturbances such as irritability, aggression, agitation, anger, anxiety, apathy, and hostility on the other hand.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Experimental | Drug: Levetiracetam• Group (A) will receive oral levetiracetam at a dose of 15-20 mg/kg/day twice daily at the onset of fever (temperature >37.5 c) for 48h after subsiding of fever. |
| Group (B) | Experimental | Drug: Diazepam• Group (B) will receive diazepam at a dose of 0.3 mg/kg/dose was given every eight hours for 48h after subsiding of fever Children were followed up for 12 months to find out seizure frequency associated with febrile events and febrile seizure recurrence rate during 12 months follow-up |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Included children 6 months to 36 months with febrile seizures after exclusion of CNS infections .
Key exclusion criteria (6 listed)
- Non-febrile seizures
- Head trauma
- CNS infections
- Known metabolic diseases
- Known genetic disorders
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 |
|---|---|---|
| LevetiracetamAlso: TiratamGroup with oral levetiracetam at a dose of 15-20 mg/kg/day | Drug | Group (A) |
| DiazepamAlso: ValinilGroup with diazepam at a dose of 0.3 mg/kg/dose | Drug | Group (B) |
Primary outcome
The rate of therapeutic effect of oral levetiracetam on febrile convulsions
Time frame: Baseline
The rate of therapeutic effect of oral levetiracetam in reducing the recurrence of febrile seizures in children aged 6-36months.
The rate of therapeutic effect of intermittent diazepam on febrile convulsions
Time frame: Baseline
The rate of therapeutic effect of intermittent diazepam in reducing the recurrence of febrile seizures in children aged 6-36months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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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.
Khaled Elsayah, Prof principal investigator
Assiut University
Khalaf Abd El-Aal, Assist prof principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Levetiracetam and Diazepam in people with Febrile Convulsion, run by Assiut 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 May 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kariman Hussein (01014121203, karimanhussein219@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of therapeutic effect of oral levetiracetam on febrile convulsions (time frame: Baseline). The study lists 2 primary outcomes in all. 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 16 May 2023.