Addition of Pyridoxine to Prednisolone in Infantile Spasms

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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

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.

Study Phase

Phase 3

Study Type


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


Infantile Spasms


Pyridoxine plus prednisolone

Study Arms / Comparison Groups

 Pyridoxine plus prednisolone
Description:  allocated patients receive pyridoxine (30 mg/kg/day) in addition to prednisolone


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

November 2012

Completion Date

March 2014

Primary Completion Date

March 2014

Eligibility 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.





3 Months - 36 Months

Accepts Healthy Volunteers



Satinder Aneja, MD, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

Lady Hardinge Medical College

Study Sponsor

Satinder Aneja, MD, Principal Investigator, Lady Hardinge Medical College

Verification Date

January 2019