Infantile spasm
Conditions
Interventions
melatonin group:add melatonin
placebo group:add placebo
Sponsors
Department of Pediatrics, The First Medical Center, General Hospital of the People's Liberation Army of China
Eligibility
Sex/Gender
All
Age
No minimum to 2 Years
Inclusion criteria
Inclusion criteria: 1.Aged >= 3 months and < 2 years; 2.Diagnostic criteria for IS developed by the International Antiepileptic Union in 2017; 3.Able to coordinate and complete the examination of various scales during the trail period.
Exclusion criteria
Exclusion criteria: 1.Patients who have previously received hormone or ACTH therapyVitamin B6 or melatoninogenic drugs within 1 month; 2.Patients who have experienced change in the type and frequency of seizures or the type and quantity of AEDs within 1 month; 3.Patients who are currently on treatment with sedatives or benzodiazepines drugs; 4.Patients who are with bleeding or clotting disorders or on anticoagulant therapy; 5.Allergic to melatonin; 6.Diabetes mellitus; 7.Severe incomplete medical history.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the average seizure remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in the frequency of seizures;the EEG assessment;developmental evaluation; | — |
Countries
China
Contacts
Public ContactYang Guang
Department of Pediatrics, The First Medical Center, General Hospital of the People's Liberation Army of China
Outcome results
None listed