Intractable epilepsy. Epilepsy
Conditions
Interventions
Intervention group: Melatonin at a rate of 10 mg /m2 was given 30 minutes before bedtime and then after 24 hours placebo administered..
Treatment - Drugs
Intervention group: Melatonin at a rate of 10 mg /m2 was given 30 minutes before bedtime and then after 24 hours placebo administered.
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Years to 15 Years
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parents’ satisfaction from drug. Timepoint: 2 sets of each 4 week. Method of measurement: spicial forms that complete with parents.;Parents' satisfaction from Sleep. Timepoint: 2 sets of each 4 week. Method of measurement: spicial forms that complete with parents.;Seizures frequency. Timepoint: 2 sets of each 4 week. Method of measurement: spicial forms that complete with parents.;Duration of every seizure. Timepoint: 2 sets of each 4 week. Method of measurement: spicial forms that complete with parents. | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma melatonin level. Timepoint: brfore and after melatonin administration. Method of measurement: blood sample.;Plasma levels of antiepileptic drugs. Timepoint: before and after melatonin administration. Method of measurement: blood sample.;Side effects. Timepoint: During the study within 8 weeks. Method of measurement: question from parants. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSaeedeh Talebi
Mashhad University of Medical Sciences
Outcome results
None listed