Health Condition 1: null- West Syndrome
Conditions
Interventions
Intervention1: Oral Zonisamide: Oral antiepileptic drug. The initial daily dose of Zonisamide will be 2-8 mg/kg body weight. It will be administered orally in two divided doses. Daily dosage will be i
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of West syndrome by clinical assessment and EEG
Exclusion criteria
Exclusion criteria: 1.Suspected or proven cases of tuberous sclerosis 2.Suspected or proven neurometabolic disease, degenerative brain disease and any progressive neurologic disease other than West syndrome 3.Previous treatment (within 28 days) with or a known contraindication to ACTH or zonisamide treatment 4. Inability of parents or guardians to give informed signed consent 5. Inability of parents or guardians to provide data of outcome as when spasms stop / Inability to come for follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Side effect profile (numbers, proportions and description as per annexure II) and number of withdrawal from the study 2.Proportion of children who would have cessation of spasms after 14 days of treatment. Timepoint: 1. At baseline 2. Days 14-21 after initiation of treatment 3. Days 42-49 after initiation of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of children who would have resolution of hypsarrhythmia 2.Time (days) to cessation of spasms 3.Development quotient as determined by Development assessment scale for Indian Infants, performed on baseline, day 28-35 & day 90-104 after initiation of treatment Timepoint: a. At baseline b. Days 14-21 c. Days 42-49 after initiation of treatment | — |
Countries
India
Contacts
Public ContactProf Pratibha Singhi
PGIMER, Chandigarh
Outcome results
None listed