Whether high dose oral pyridoxine as an add on therapy to standard therapy ACTH is safe and efficacious than standard therapy of ACTH alone in the treatment of infantile spasms
Phase 4
Completed
- Conditions
- Health Condition 1: null- Infantile spasm patients diagnosedclinicallyand byEEGAge3to18months
- Registration Number
- CTRI/2017/12/010742
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
Infantile spasm patients diagnosed clinically and by EEG
Age 3to18 months
Exclusion Criteria
Proven/ suspected case of Tuberous Sclerosis
b) Proven/suspected case of neurometabolic, neurodegenerative or any other progressive disorder
c) Previously treated patients with ACTH, oral steroids (within 28 days) and pyridoxine
d) Contraindications to ACTH and pyridoxine therapy like cushingoid state, fever, diarrhea, hypertension
e) Inability of parents/guardians to provide informed consent
f) Inability of parents/guardians to provide data of outcome of spasms
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of children with Complete cessation of spasmsTimepoint: 14-21 days,42-49 days and 90-104 days
- Secondary Outcome Measures
Name Time Method Proportion of children who had reduction of frequency of epileptic spasms by more than 50% <br/ ><br> <br/ ><br> <br/ ><br>â?¢Time taken to attain cessation of epileptic spasms (in days) after initiation of treatment with ACTH and high dose oral pyridoxine versus ACTH monotherapy <br/ ><br>â?¢ To determine improvement of development quotient (as assessed by Development assessment scale for Indian Infants, <br/ ><br> <br/ ><br> <br/ ><br>â?¢Safety by the side effect profile of the drugsTimepoint: 14-21 days, 42-49 days and 90-104 days;Proportion of children who are free of spasms <br/ ><br>Proportion of children who had reduction <br/ ><br> in frequency of epileptic spasms 50% <br/ ><br>Time taken for the cessation of spasms after initiation of therapy <br/ ><br>To assess the improvement in development quotient <br/ ><br>To asess the side effect profile of the patients on ACTH/ Pyridoxine <br/ ><br>Timepoint: 14-21 days, 42-49 days and 90-104 days