A Randomized Control Trial on effectiveness of Clonazepam Versus Nitrazepam after failure of Steroids and Vigabatrin in Infantile Epileptic Spasm Syndrome.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- To asses the Response in participants in term of reduction in number of spasms
Study Overview
Brief Summary
Infantile Epileptic Spasm Syndrome which is Characterised by Epileptic spasms, Developmental Delay and Hypsarrhythmia or its varient on EEG, is a difficult to treat syndrome.The infantile spasms are initially treated with Steroids(ACTH or Prednisolone) and Vigabatrin. However not all cases respond to the first line therapy .Hence second line therapy with Benzodiazepines and other drugs are used to treat these resistant cases. But there is paucity of trialsand literature on the Second line therapy more so on Benzodiazepines. Hence this study was undertaken to compare effectiveness of two commonly used Benzodiazepines Nitrazepam and Clonazepam in Infantile Epileptic Spasm Syndrome.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 3.00 Month(s) to 3.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children diagnosed with west syndrome not responding to steroids and Vigabatrin.
Exclusion Criteria
- •Children in whom Benzodiazepines are contraindicated.
- •Children inncompletely treated or partially treated with First Line Drugs.
Outcomes
Primary Outcomes
To asses the Response in participants in term of reduction in number of spasms
Time Frame: To asses the Response in participants in term of reduction in number of spasms after 2 weeks of Starting the Drug Therapy then follow up after 1motn,3month and 6month.
Secondary Outcomes
- Developmental improvement in all the developmental milestones.(At the end of 6 months of study)
Investigators
Dr Vidya
INDIRA GANDHI INSTITUE OF CHILD HEALTH ,