Addition of Pyridoxine to Prednisolone in Infantile Spasms
Information source: Lady Hardinge Medical College
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infantile Spasms
Intervention: Pyridoxine plus prednisolone (Drug); Prednisolone (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Lady Hardinge Medical College Official(s) and/or principal investigator(s):
Satinder Aneja, MD, Principal Investigator, Affiliation: Lady Hardinge Medical College
Overall contact:
Suvasini Sharma, DM, Email: sharma.suvasini@gmail.com
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 hypsarrhythmia. When all 3 components are present, the eponym "West syndrome"
is commonly used. West syndrome is a catastrophic epileptic encephalopathy. It does not
respond well to standard anti-epileptic drugs. Hormonal therapy is the mainstay in the
treatment of infantile spasms. This includes adreno-cortico trophic hormone (ACTH) and oral
steroids. Variable dose of prednisolone used in the treatment. Oral prednisolone used in
usual dose (2mg/kg) has been shown to be less effective as compared to ACTH. High dose
prednisolone (4mg/kg) has been used in the treatment of infantile spasms, which has been
shown to be as effective as ACTH. Pyridoxine has been used as first line treatment in Japan,
however there is paucity of data on the efficacy of combination of pyridoxine with hormonal
therapy. There are no studies comparing add on pyridoxine with high prednisolone versus
high dose prednisolone alone in the treatment of infantile spasms. Therefore the study has
been planned to see whether the addition of pyridoxine with high dose prednisolone in the
treatment of infantile spasms improves the efficacy in terms of spasm cessation.
Clinical Details
Official title: Addition of Pyridoxine to Prednisolone in the Treatment of Infantile Spasms: A Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proportion of children who achieved complete cessation spasm for at least 48 hours as per parental reports at the end of 2 weeks in both the groups.
Secondary outcome: • Proportion of children who achieved more than 50 % reduction of clinical spasms as per parental reports at the end of 2 weeks
Eligibility
Minimum age: 3 Months.
Maximum age: 36 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age in 3months-3years.
2. Presence of epileptic spasms (1 or more clusters per day) with EEG evidence of
hypsarrythmia or its variants.
-
Exclusion Criteria:
1. Children with active systemic illness
2. Children with evidence of active tuberculosis
3. Severe Acute Malnutrition (standard deviation scores below median weight for height)
4. Children with recurrent illness/chronic systemic illness
5. Prior treatment of pyridoxine, steroid, or ACTH.
-
Locations and Contacts
Suvasini Sharma, DM, Email: sharma.suvasini@gmail.com
Lady Hardinge Medical College, New Delhi, India; Recruiting
Suvasini Sharma, MD, Email: sharma.suvasini@gmail.com
Additional Information
Starting date: March 2013
Last updated: April 9, 2013
|
