Febrile SeizuresPhase 4NCT03631901
Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures
A Phase 4 study testing oral melatonin and oral diazepam in people with Febrile Seizures, run by Tanta University at 1 site in Egypt.
Trial summary
To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrent simple febrile seizures. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Febrile Seizures
- What is being tested?
- oral melatonin and oral diazepam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2017to 1 Sep 2018
- 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 months to 5 yrs .
- Simple febrile seizures
Who cannot join
- Complex febrile seizures
- Child with history of neonatal seizure.
- Afebrile seizures.
- History of anticonvulsive therapy.
- Children suffering from epilepsy.
- Children with abnormal EEG.
- Children with abnormal neurological examination.
- Positive family history of epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures: Randomized Clinical Trial
To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrent simple febrile seizures.
Read the detailed description
To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrence of simple febrile seizures in children aged 6 months to 5 years.
- Conditions
- Febrile Seizures
- Being tested
- oral melatonin, oral diazepam
- Keywords
- Melatonin, Diazepam, recurrence, prophylaxis, Febrile convulsions
- Medical subject headings
- Seizures, Febrile, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral melatoninDrug
Both melatonin and diazepam were given only during the febrile illness.
oral diazepamDrug
Both melatonin and diazepam were given only during the febrile illness.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Active comparator | melatonin 0.3mg/kg/8 hours, orally. Given only during the febrile illness. Receives: Drug: oral melatonin |
| Diazepam | Active comparator | oral diazepam 1mg/kg/day divided into 3 doses. Given only during the febrile illness. Receives: Drug: oral diazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of febrile seizures during febrile illness
Measured: 6 months
Secondary outcomes (1)
side effect of medications reported in children
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start1 Apr 2017
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile SeizuresStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
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, Principal investigator, Tanta University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631901
- Sponsor's protocol ID
- TU2017
- Status last verified
- Sep 2019
- First submitted
- 13 Aug 2018
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03631901
- Acronym / sponsor ID
- TU2017
- Conditions
- Febrile Seizures
- Keywords
- Melatonin, Diazepam, recurrence, prophylaxis, Febrile convulsions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 15 Aug 2018 (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.
To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrent simple febrile seizures.
Detailed description
To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrence of simple febrile seizures in children aged 6 months to 5 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Active comparator | Drug: oral melatoninmelatonin 0.3mg/kg/8 hours, orally. Given only during the febrile illness. |
| Diazepam | Active comparator | Drug: oral diazepamoral diazepam 1mg/kg/day divided into 3 doses. Given only during the febrile illness. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 6 months to 5 yrs .
- Simple febrile seizures
Key exclusion criteria (8 listed)
- Complex febrile seizures
- Child with history of neonatal seizure.
- Afebrile seizures.
- History of anticonvulsive therapy.
- Children suffering from epilepsy.
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 |
|---|---|---|
| oral melatoninBoth melatonin and diazepam were given only during the febrile illness. | Drug | Melatonin |
| oral diazepamBoth melatonin and diazepam were given only during the febrile illness. | Drug | Diazepam |
Primary outcome
recurrence of febrile seizures during febrile illness
Time frame: 6 months
1 secondary outcome
side effect of medications reported in children
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 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 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 oral melatonin and oral diazepam in people with Febrile Seizures, 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 12 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of febrile seizures during febrile illness (time frame: 6 months). 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 12 Sep 2019.