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Addition of Pyridoxine to Prednisolone in Infantile Spasms

Primary Purpose

Infantile Spasms

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Pyridoxine plus prednisolone
Prednisolone
Sponsored by
Lady Hardinge Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infantile Spasms

Eligibility Criteria

3 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

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.

    -

Sites / Locations

  • Lady Hardinge Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pyridoxine plus prednisolone

Prednisolone

Arm Description

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

allocated patients receive prednisolone alone

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 7, 2013
Last Updated
January 12, 2019
Sponsor
Lady Hardinge Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT01828437
Brief Title
Addition of Pyridoxine to Prednisolone in Infantile Spasms
Official Title
Addition of Pyridoxine to Prednisolone in the Treatment of Infantile Spasms: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lady Hardinge Medical College

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Spasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pyridoxine plus prednisolone
Arm Type
Experimental
Arm Description
allocated patients receive pyridoxine (30 mg/kg/day) in addition to prednisolone
Arm Title
Prednisolone
Arm Type
Active Comparator
Arm Description
allocated patients receive prednisolone alone
Intervention Type
Drug
Intervention Name(s)
Pyridoxine plus prednisolone
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
• Proportion of children who achieved more than 50 % reduction of clinical spasms as per parental reports at the end of 2 weeks
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age in 3months-3years. Presence of epileptic spasms (1 or more clusters per day) with EEG evidence of hypsarrythmia or its variants. - Exclusion Criteria: 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satinder Aneja, MD
Organizational Affiliation
Lady Hardinge Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lady Hardinge Medical College
City
New Delhi
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
29547159
Citation
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.
Results Reference
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Addition of Pyridoxine to Prednisolone in Infantile Spasms

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