Status EpilepticusPhase 4NCT04829838
Comparison of Efficacy of Phenytoin With Levetireacetam for the Management of Children With Status Epilepticus
A Phase 4 study testing intravenous levetireacetam in people with Status Epilepticus, run by ayesha tariq at 1 site in Pakistan.
Trial summary
The purpose of studyis to compare the efficacy of phenytoin with levetiracetam for the management of children with status epilepticus.Study performa consists of demographic variables,exclusion criteria,history of epilepsy and efficacy achieved or not. Read more about this study
- Who is it for?
- Ages 2 months to 12 years
- Conditions the study is for
- Status Epilepticus
- What is being tested?
- intravenous levetireacetam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Jul 2019to 26 Jul 2021
- 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 2 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- childen of age less than 12 years either gender admitted in pediatric emergency with status epilepticus
Who cannot join
- children already taking either of trial drug or failed treatment with either of trial drug.children with comorbid conditions
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ayesha Tariq
Lahore, Punjab Province
ayesha tariq, MBBS, 0923360495413, docayesha86@gmail.com
About this study
The purpose of studyis to compare the efficacy of phenytoin with levetiracetam for the management of children with status epilepticus.Study performa consists of demographic variables,exclusion criteria,history of epilepsy and efficacy achieved or not.
Read the detailed description
After getting informed consent 244 children with status epilepticus will be randomly classified into two groups.one group will receive levetireacetam and other group will be given phenytoin and their efficacy will be compared by observing them for breakthrough fits for next 48 hours.
- Conditions
- Status Epilepticus
- Being tested
- intravenous levetireacetam
- Keywords
- status epilepticus, children, phenytoin, levetireacetam
- 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 levetireacetamDrug
phenytoin is considered as control drug in the study
| Study group | Role | What they receive |
|---|---|---|
| Intravenous levetireacetam | Experimental | Drug:Intravenous levetireacetam will be given at a loading dose of 20-30mg/kg then it will be added in maintainance dose of (5-30mg/kg/day) Receives: Drug: intravenous levetireacetam |
| intravenous phenytoin | Experimental | Intravenous phenytoin will be given in loading dose of 20mg/kg then it will be added in maintainance dose i-e 5-8mg/kg/day Receives: Drug: intravenous levetireacetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of efficacy of levetireacetam with phenytoin for the management of children with status epilepticus
the intervention will be considered efficacious if child will not have breakthrough fits for 48 hours
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start25 Jul 2019
- Primary completion26 Jul 2021 (estimated)
- Study completion26 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ayesha tariq
- Sponsor type
- University, hospital or other
- Collaborators
- King Edward Medical University
- Responsible party
- Sponsor-investigator, ayesha tariq, King Edward Medical University
- Investigators
- Haroon Hamid, MBBS,FCPS, Principal investigator, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829838
- Sponsor's protocol ID
- 700/RC/KEMU
- Status last verified
- Mar 2021
- First submitted
- 31 Mar 2021
- Last updated
- 2 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Smith DM, McGinnis EL, Walleigh DJ, Abend NS. Management of Status Epilepticus in Children. J Clin Med. 2016 Apr 13;5(4):47. doi: 10.3390/jcm5040047.
PubMed 27089373Abend NS, Loddenkemper T. Pediatric status epilepticus management. Curr Opin Pediatr. 2014 Dec;26(6):668-74. doi: 10.1097/MOP.0000000000000154.
PubMed 25304961
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Phenytoin With Levetireacetam for the Management of Children With Status Epilepticus
- ClinicalTrials.gov ID
- NCT04829838
- Acronym / sponsor ID
- 700/RC/KEMU
- Conditions
- Status Epilepticus
- Keywords
- status epilepticus, children, phenytoin, levetireacetam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- ayesha tariqUniversity, hospital or other
- Collaborators
- King Edward Medical University
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 26 Jul 2021 (estimated)
- Study completion
- 26 Jul 2021 (estimated)
- First posted
- 2 Apr 2021 (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 purpose of studyis to compare the efficacy of phenytoin with levetiracetam for the management of children with status epilepticus.Study performa consists of demographic variables,exclusion criteria,history of epilepsy and efficacy achieved or not.
Detailed description
After getting informed consent 244 children with status epilepticus will be randomly classified into two groups.one group will receive levetireacetam and other group will be given phenytoin and their efficacy will be compared by observing them for breakthrough fits for next 48 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous levetireacetam | Experimental | Drug: intravenous levetireacetamDrug:Intravenous levetireacetam will be given at a loading dose of 20-30mg/kg then it will be added in maintainance dose of (5-30mg/kg/day) |
| intravenous phenytoin | Experimental | Drug: intravenous levetireacetamIntravenous phenytoin will be given in loading dose of 20mg/kg then it will be added in maintainance dose i-e 5-8mg/kg/day |
Who may qualify
- Ages
- 2 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- childen of age less than 12 years either gender admitted in pediatric emergency with status epilepticus
Key exclusion criteria (1 listed)
- children already taking either of trial drug or failed treatment with either of trial drug.children with comorbid conditions
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 levetireacetamphenytoin is considered as control drug in the study | Drug | Intravenous levetireacetam, intravenous phenytoin |
Primary outcome
comparison of efficacy of levetireacetam with phenytoin for the management of children with status epilepticus
Time frame: 48 hours
the intervention will be considered efficacious if child will not have breakthrough fits for 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Background: PubMed 27089373Smith DM, McGinnis EL, Walleigh DJ, Abend NS. Management of Status Epilepticus in Children. J Clin Med. 2016 Apr 13;5(4):47. doi: 10.3390/jcm5040047.
- Background: PubMed 25304961Abend NS, Loddenkemper T. Pediatric status epilepticus management. Curr Opin Pediatr. 2014 Dec;26(6):668-74. doi: 10.1097/MOP.0000000000000154.
- Individual participant dataSharing planned: Yes
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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.
Haroon Hamid, MBBS,FCPS principal investigator
King Edward Medical University
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 intravenous levetireacetam in people with Status Epilepticus, run by ayesha tariq 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 1 inclusion and 1 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 2 Apr 2021. 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.
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 ayesha tariq, MBBS (0923360495413, docayesha86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of efficacy of levetireacetam with phenytoin for the management of children with status epilepticus (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04829838, which also lists 2 linked publications.
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 2 Apr 2021.