Extended ACTH/Steroids therapy trial in West Syndrome
Phase 3
- Conditions
- Health Condition 1: G404- Other generalized epilepsy and epileptic syndromes
- Registration Number
- CTRI/2019/04/018773
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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