NCT03631901

Brief Summary

To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrent simple febrile seizures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

1.4 years

First QC Date

August 13, 2018

Last Update Submit

September 11, 2019

Conditions

Febrile Seizures

Keywords

MelatoninDiazepamrecurrenceprophylaxisFebrile convulsions

Outcome Measures

Primary Outcomes (1)

  • recurrence of febrile seizures during febrile illness

    6 months

Secondary Outcomes (1)

  • side effect of medications reported in children

    6 months

Study Arms (2)

Melatonin

ACTIVE COMPARATOR

melatonin 0.3mg/kg/8 hours, orally. Given only during the febrile illness.

Drug: oral melatonin

Diazepam

ACTIVE COMPARATOR

oral diazepam 1mg/kg/day divided into 3 doses. Given only during the febrile illness.

Drug: oral diazepam

Interventions

oral melatoninDRUG

Both melatonin and diazepam were given only during the febrile illness.

Melatonin
oral diazepamDRUG

Both melatonin and diazepam were given only during the febrile illness.

Diazepam

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6 months to 5 yrs .
  • Simple febrile seizures

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University, Faculty of Medicine

Tanta, Egypt

Location

MeSH Terms

Conditions

Seizures, FebrileRecurrence

Interventions

MelatoninDiazepam

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsBenzodiazepinonesBenzodiazepinesBenzazepines

Study Officials

  • Amira Darwish

    Tanta University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of pediatrics and Principal Investigator

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 15, 2018

Study Start

April 1, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

September 12, 2019

Record last verified: 2019-09

Locations

EG(1)