Addition of Pyridoxine to Prednisolone in Infantile Spasms

Infantile Spasms Clinical Trial

Official title:

Addition of Pyridoxine to Prednisolone in the Treatment of Infantile Spasms: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828437
• Other study ID #: PYRIPREDIS
• Status: Completed
• Phase: Phase 3
• Start date: November 2012
• Est. completion date: March 2014

Study information

• Verified date: January 2019
• Source: Lady Hardinge Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Infantile Spasms
• Spasm
• Spasms, Infantile

Intervention

Drug:
• Pyridoxine plus prednisolone

• Prednisolone

Locations

Country	Name	City	State
India	Lady Hardinge Medical College	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Lady Hardinge Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	2 weeks
Secondary	• Proportion of children who achieved more than 50 % reduction of clinical spasms as per parental reports at the end of 2 weeks		2 weeks