EpilepsyPhase 3NCT05291455
Lacosamide in Neonatal Status Epilepticus
A Phase 3 study testing Lacosamide and Phenobarbital in people with Epilepsy, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Lacosamide in neonatal status epilepticus Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Epilepsy
- What is being tested?
- Lacosamide and Phenobarbital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 1 Apr 2024
- Phase
- Phase 3
- 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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- neonates with status epilepticus
Who cannot join
- congenital anomalies or organ dysfunction
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University
Tanta, Kafrelsheikh
abeer salamah, lecturer, 0201009221243
About this study
Official title: Efficacy of Lacosamide in Neonatal Status Epilepticus: A Randomized Controlled Study
Lacosamide in neonatal status epilepticus
Read the detailed description
The study will assess the efficacy of Lacosamide in neonatal status epilepticus
- Conditions
- Epilepsy
- Being tested
- Lacosamide, Phenobarbital
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacosamideDrug
Also called lacosa
lacosamide will be given
PhenobarbitalDrug
Also called phenobarbitone
phenobarbital will be given
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide | Experimental | Lacosamide will be given. Receives: Drug: Lacosamide |
| Phenobarbitone | Active comparator | Phenobarbital will be given Receives: Drug: Phenobarbital |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of children with cessation or improved duration of status epilepticus
the number of children with cessation or improved duration of status epilepticus
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Mar 2022
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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 3
- 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
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- abeer salamah, lecturer, Principal investigator, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291455
- Sponsor's protocol ID
- abeer ped neurology
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lacosamide in Neonatal Status Epilepticus: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05291455
- Acronym / sponsor ID
- abeer ped neurology
- Conditions
- Epilepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 22 Mar 2022 (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.
Lacosamide in neonatal status epilepticus
Detailed description
The study will assess the efficacy of Lacosamide in neonatal 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 |
|---|---|---|
| Lacosamide | Experimental | Drug: LacosamideLacosamide will be given. |
| Phenobarbitone | Active comparator | Drug: PhenobarbitalPhenobarbital will be given |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- neonates with status epilepticus
Key exclusion criteria (1 listed)
- congenital anomalies or organ dysfunction
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 |
|---|---|---|
| LacosamideAlso: lacosalacosamide will be given | Drug | Lacosamide |
| PhenobarbitalAlso: phenobarbitonephenobarbital will be given | Drug | Phenobarbitone |
Primary outcome
number of children with cessation or improved duration of status epilepticus
Time frame: 1 year
the number of children with cessation or improved duration of status epilepticus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: No
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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.
abeer salamah, lecturer principal investigator
Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lacosamide and Phenobarbital in people with Epilepsy, run by Sherief Abd-Elsalam 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 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 22 Mar 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 abeer salamah, lecturer (00201009221243, abeersalamah84@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of children with cessation or improved duration of status epilepticus (time frame: 1 year). 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 22 Mar 2022.