ComparisonPhase 4NCT04176887
Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus
A Phase 4 study testing Levetiracetam Injection and Phenytoin Injection in people with Comparison and the Efficacy of Levetireacetam, run by Tanta University at 1 site in Egypt.
Trial summary
The study will be conducted on 60 children suffering from status epilepticus who will be admitted to Pediatric Neurology Unit and Pediatric ICU of Tanta Hospital University. Read more about this study
- Who is it for?
- Ages 30 days to 18 years
- Conditions the study is for
- Comparison, the Efficacy of Levetireacetam, Phenytoin
- What is being tested?
- Levetiracetam Injection and Phenytoin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Aug 2020
- Phase
- Phase 4
- 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 30 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children suffering from convulsive generalized tonic clonic status epilepticus at any age.
Who cannot join
- Non convulsive status epilepticus.
- Children with known contraindication or allergy to levetireacetam or phenytoin.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University, Faculty of Medicine
Tanta, Gharbia Governorate, 3111
Azza Kamal Al-shahawy, Professor of pediatrics, azzaalshahawy@gmail.com
About this study
Official title: Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus: a Randomized Clinical Trial
The study will be conducted on 60 children suffering from status epilepticus who will be admitted to Pediatric Neurology Unit and Pediatric ICU of Tanta Hospital University.
Read the detailed description
The aim of this work is to compare the efficacy of Levetireacetam and Phenytoin in management of pediatric status epilepticus.
- Conditions
- Comparison, the Efficacy of Levetireacetam, Phenytoin, Management of Pediatric Status Epilepticus
- Being tested
- Levetiracetam Injection, Phenytoin Injection
- Keywords
- Levetireacetam, Phenytoin, status epilepticus, children
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levetiracetam InjectionDrug
Also called levetiracetam
The levetiracetam dose is 20- 40 mg/kg by intravenous infusion over 15 minute, a rate of 2-5 mg/kg/minute diluted in 100 ml with 0.9% sodium chloride as a single dose.
Phenytoin InjectionDrug
Also called Phenytoin
Phenytoin dose is 20-40 mg/kg/min by intravenous infusion over 30 minute, diluted with 0.9% sodium chloride to a maximum concentration of 10 mg/ml.
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Experimental | The levetiracetam dose is 20- 40 mg/kg by intravenous infusion over 15 minute, a rate of 2-5 mg/kg/minute diluted in 100 ml with 0.9% sodium chloride as a single dose. Receives: Drug: Levetiracetam Injection |
| Phenytoin | Active comparator | Phenytoin dose is 20-40 mg/kg/min by intravenous infusion over 30 minute, diluted with 0.9% sodium chloride to a maximum concentration of 10 mg/ml. Receives: Drug: Phenytoin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
cessation of convulsion
seizure control based on stoppage of tonic and clonic movements and absence of epileptic activity in EEG
Measured: 30 minutes
Secondary outcomes (4)
bradycardia
monitoring of heart rate
Measured: 6 hours
respiratory depression
monitoring of respiratory rate
Measured: 6 hours
decreased conscious level
Glasgow Coma Score
Measured: 6 hours
hypotension
measurement of blood pressure
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start1 Jan 2019
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComparisonStudies of the same condition, open and under way.
- More trials run by Tanta 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Hamed Darwish, Tanta University
- Investigators
- Amira Darwish, MD, Principal investigator, Tanta University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176887
- Sponsor's protocol ID
- TUjune2018
- Status last verified
- Nov 2019
- First submitted
- 11 Sep 2019
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04176887
- Acronym / sponsor ID
- TUjune2018
- Conditions
- Comparison, the Efficacy of Levetireacetam, Phenytoin, Management of Pediatric Status Epilepticus
- Keywords
- Levetireacetam, Phenytoin, status epilepticus, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 25 Nov 2019 (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 study will be conducted on 60 children suffering from status epilepticus who will be admitted to Pediatric Neurology Unit and Pediatric ICU of Tanta Hospital University.
Detailed description
The aim of this work is to compare the efficacy of Levetireacetam and Phenytoin in management of pediatric status epilepticus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | Experimental | Drug: Levetiracetam InjectionThe levetiracetam dose is 20- 40 mg/kg by intravenous infusion over 15 minute, a rate of 2-5 mg/kg/minute diluted in 100 ml with 0.9% sodium chloride as a single dose. |
| Phenytoin | Active comparator | Drug: Phenytoin InjectionPhenytoin dose is 20-40 mg/kg/min by intravenous infusion over 30 minute, diluted with 0.9% sodium chloride to a maximum concentration of 10 mg/ml. |
Who may qualify
- Ages
- 30 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children suffering from convulsive generalized tonic clonic status epilepticus at any age.
Key exclusion criteria (2 listed)
- Non convulsive status epilepticus.
- Children with known contraindication or allergy to levetireacetam or phenytoin.
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 |
|---|---|---|
| Levetiracetam InjectionAlso: levetiracetamThe levetiracetam dose is 20- 40 mg/kg by intravenous infusion over 15 minute, a rate of 2-5 mg/kg/minute diluted in 100 ml with 0.9% sodium chloride as a single dose. | Drug | Levetiracetam |
| Phenytoin InjectionAlso: PhenytoinPhenytoin dose is 20-40 mg/kg/min by intravenous infusion over 30 minute, diluted with 0.9% sodium chloride to a maximum concentration of 10 mg/ml. | Drug | Phenytoin |
Primary outcome
cessation of convulsion
Time frame: 30 minutes
seizure control based on stoppage of tonic and clonic movements and absence of epileptic activity in EEG
4 secondary outcomes
bradycardia
Time frame: 6 hours
respiratory depression
Time frame: 6 hours
decreased conscious level
Time frame: 6 hours
hypotension
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
Amira Darwish, MD principal investigator
Tanta University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levetiracetam Injection and Phenytoin Injection in people with Comparison and the Efficacy of Levetireacetam, run by Tanta University at 1 site in Egypt.
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 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: status not confirmed, as of the sponsor's last update on 25 Nov 2019. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Amira Darwish, MD (+1026380311, amira.darwish@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cessation of convulsion (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 25 Nov 2019.