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Addition of Pyridoxine to Prednisolone in Infantile Spasms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01828437
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Satinder Aneja, Lady Hardinge Medical College

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infantile Spasms Drug: Pyridoxine plus prednisolone Drug: Prednisolone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Addition of Pyridoxine to Prednisolone in the Treatment of Infantile Spasms: A Randomized Controlled Trial
Study Start Date : November 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Cramps

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pyridoxine plus prednisolone
allocated patients receive pyridoxine (30 mg/kg/day) in addition to prednisolone
 Drug: Pyridoxine plus prednisolone
Active Comparator: Prednisolone
allocated patients receive prednisolone alone
 Drug: Prednisolone


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 2 weeks ]
    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 :
  1. • 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 ]

Eligibility Criteria
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Ages Eligible for Study:   3 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

    -

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828437


Locations
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India
Lady Hardinge Medical College
New Delhi, India
Sponsors and Collaborators
Lady Hardinge Medical College
Investigators
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Principal Investigator: Satinder Aneja, MD Lady Hardinge Medical College
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Satinder Aneja, Director Professor and Head, Lady Hardinge Medical College
ClinicalTrials.gov Identifier: NCT01828437    
Other Study ID Numbers: PYRIPREDIS
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Spasm
Spasms, Infantile
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
Epileptic Syndromes
Pyridoxine
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
 Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents