In this pilot crossover study, the investigators examined the effect of melatonin on seizures, sleep quality, and behavior in 20 patients. Children with drug-resistant epilepsy, who had referred to epileptic clinic of Qaem hospital, were randomly assigned to receive treatment with melatonin or placebo for 4 weeks and after the washout period; patients who started with melatonin were switched to placebo. Melatonin was administered 30 minutes before bedtime in dose of 0.3 mg /kg of 3 mg tablets. Inclusion criteria: age in pediatrics' range between 1 to 15 years old; failure of at least 3 different antiepileptic drugs to control seizures; therapeutic stability for at least 1 month prior to the study, and 4 seizures or more in the last month prior to the initiation of the study.
Exclusion criteria: history of neurodegenerative disorders syndromes,
cardiovascular anomalies, liver and kidney dysfunction; history of pseudo seizures, seizures with so large numbers and variety that were uncountable; history of status or progressive seizure attack.
Study outcomes: seizures duration, sleep quality, and behavior.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100730187N1
Registration date:2016-10-22, 1395/08/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-22, 1395/08/01
Registrant information
Name
Saeedeh Talebi
Name of organization / entity
Pediateric ward, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3845 5241
Email address
talebis2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2012-03-10, 1390/12/20
Expected recruitment end date
2012-11-10, 1391/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of melatonin on pediateric drug resistant epilepcy
Public title
The effect of melatonin on pediateric drug resistant epilepcy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age in pediatrics' range between 1 to 15 years old; failure of at least 3 different antiepileptic drugs to control seizures; therapeutic stability for at least 1 month prior to the study, and 4 seizures or more in the last month prior to the initiation of the study.
Exclusion criteria: history of neurodegenerative disorders syndromes,
cardiovascular anomalies, liver and kidney dysfunction; history of pseudo seizures, seizures with so large numbers and variety that were uncountable; history of status or progressive seizure attack.
Age
From 1 year old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Qureshi Building, Mashhad University of Medical Sciences, Daneshgah St.
City
Mashhad
Postal code
Approval date
2012-02-08, 1390/11/19
Ethics committee reference number
900519
Health conditions studied
1
Description of health condition studied
Intractable epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy
Primary outcomes
1
Description
parents’ satisfaction from drug
Timepoint
2 sets of each 4 week
Method of measurement
spicial forms that complete with parents
2
Description
Parents' satisfaction from Sleep
Timepoint
2 sets of each 4 week
Method of measurement
spicial forms that complete with parents
3
Description
Seizures frequency
Timepoint
2 sets of each 4 week
Method of measurement
spicial forms that complete with parents
4
Description
duration of every seizure
Timepoint
2 sets of each 4 week
Method of measurement
spicial forms that complete with parents
Secondary outcomes
1
Description
plasma melatonin level
Timepoint
brfore and after melatonin administration
Method of measurement
blood sample
2
Description
plasma levels of antiepileptic drugs
Timepoint
before and after melatonin administration
Method of measurement
blood sample
3
Description
side effects
Timepoint
During the study within 8 weeks
Method of measurement
question from parants
Intervention groups
1
Description
Intervention group: Melatonin at a rate of 10 mg /m2 was given 30 minutes before bedtime and then after 24 hours placebo administered.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital, pediatric neurology clinic
Full name of responsible person
Dr. Gavad Akhondian, Professor of Pediatric Neurology
Street address
Ghaem hospital, Ahmad Abad St.
City
Masshad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Eslami
Street address
Qureshi Building, Mashhad University of Medical Sciences, Daneshgah St.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?