The effect of melatonin on pediateric drug resistant epilepcy
Not Applicable
- Conditions
- Intractable epilepsy.Epilepsy
- Registration Number
- IRCT2016100730187N1
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 32
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
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.