Addition of Pyridoxine to Prednisolone in Infantile Spasms

NCT01828437 | Completed Phase 3

• 1 other identifier: PYRIPREDIS
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Infantile Spasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• • Proportion of children who achieved more than 50 % reduction of clinical spasms as per parental reports at the end of 2 weeks

  2 weeks

Study Arms (2)

Pyridoxine plus prednisolone

EXPERIMENTAL

allocated patients receive pyridoxine (30 mg/kg/day) in addition to prednisolone

Drug: Pyridoxine plus prednisolone

Prednisolone

ACTIVE COMPARATOR

allocated patients receive prednisolone alone

Drug: Prednisolone

Interventions

Pyridoxine plus prednisolone DRUG

Pyridoxine plus prednisolone

Prednisolone DRUG

Prednisolone

Eligibility Criteria

• Age: 3 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age in 3months-3years.
• Presence of epileptic spasms (1 or more clusters per day) with EEG evidence of hypsarrythmia or its variants.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

Study Sites (1)

Lady Hardinge Medical College

New Delhi, India

Location

Related Publications (1)

• Kunnanayaka V, Jain P, Sharma S, Seth A, Aneja S. Addition of pyridoxine to prednisolone in the treatment of infantile spasms: A pilot, randomized controlled trial. Neurol India. 2018 Mar-Apr;66(2):385-390. doi: 10.4103/0028-3886.227281.

  PMID: 29547159 DERIVED

MeSH Terms

Conditions

Spasms, Infantile

Interventions

Pyridoxine; Prednisolone

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Vitamin B 6; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Satinder Aneja, MD

  Lady Hardinge Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Professor and Head

Study Record Dates

• First Submitted: April 7, 2013
• First Posted: April 10, 2013
• Study Start: November 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

IN (1)