Health Condition 1: G404- Other generalized epilepsy and epileptic syndromes
Conditions
Interventions
Intervention1: Extended duration of standard intramuscular ACTH/oral steroids therapy: Extension (total 6 months duration) of intramuscular ACTH/oral steroids therapy
Control Intervention1: Standard t
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: (1)Infants 2 to 24 months of age; (2) the diagnosis of West Syndrome confirmed by clinical assessment and EEG; and (3) Initiated on ACTH/steroids therapy and cessation of spasms at 6 weeks of therapy (4) Written informed consent from a parent
Exclusion criteria
Exclusion criteria: (1) Declined to provide written informed consent by parents, (2) Suspected or proven cases of tuberous sclerosis, (3) Suspected or proven neurometabolic disease, degenerative brain disease and any progressive neurologic disease other than West syndrome, and (4) Inability by parents to come for follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of Proportion of children with relapses within 6 months of therapyTimepoint: Comparison of Proportion of children with relapses within 6 months of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean improvement in Hypsarrhythmia scores in the EEG as assessed by Modified Jeavonâ??s scoreTimepoint: Modified Jeavonâ??s score performed at 6 months and baseline;Mean improvement in neurodevelopmental scores as assessed by Development Scale for Indian InfantsTimepoint: Development Scale for Indian Infants performed at 6 months and baseline;Treatment Emergent side effects, Nature, Withdrawal of treatment/dose deviationTimepoint: During therapy extension period | — |
Countries
India
Contacts
Public ContactJitendra Kumar Sahu
Postgraduate Institute of Medical Education and Research
Outcome results
None listed