Status:
COMPLETED
Addition of Pyridoxine to Prednisolone in Infantile Spasms
Lead Sponsor:
Lady Hardinge Medical College
Conditions:
Infantile Spasms
Eligibility:
All Genders
3-36 years
Phase:
PHASE3
Brief Summary
Infantile spasms constitute a unique age specific epilepsy syndrome of infancy, characterized by epileptic spasms often accompanied by neurodevelopmental regression and an EEG finding of hypsarrhythmi...
Eligibility Criteria
Inclusion
- Age in 3months-3years.
- Presence of epileptic spasms (1 or more clusters per day) with EEG evidence of hypsarrythmia or its variants.
- \-
Exclusion
- Children with active systemic illness
- Children with evidence of active tuberculosis
- Severe Acute Malnutrition (standard deviation scores below median weight for height)
- Children with recurrent illness/chronic systemic illness
- Prior treatment of pyridoxine, steroid, or ACTH.
- \-
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01828437
Start Date
November 1 2012
End Date
March 1 2014
Last Update
January 15 2019
Active Locations (1)
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1
Lady Hardinge Medical College
New Delhi, India