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Febrile ConvulsionNCT05860153

Intermittent Levetricetam in Treatment of Febrile Convulsions

A study testing Levetiracetam and Diazepam in people with Febrile Convulsion, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

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 groups in NCT05860153
Study groupRoleWhat 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.

  1. 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

  2. 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.

  1. First posted16 May 2023
  2. Study start1 Jun 2023 (estimated)
  3. Primary completion1 Jan 2024 (estimated)
  4. Study completion1 Aug 2024 (estimated)

Resources

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)
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

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.

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