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Addition of Pyridoxine to Prednisolone in Infantile Spasms

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Lady Hardinge Medical College
Sponsor:
Information provided by (Responsible Party):
Satinder Aneja, Lady Hardinge Medical College
ClinicalTrials.gov Identifier:
NCT01828437
First received: April 7, 2013
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Infantile Spasms
Drug: Pyridoxine plus prednisolone
Drug: Prednisolone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Addition of Pyridoxine to Prednisolone in the Treatment of Infantile Spasms: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Lady Hardinge Medical College:

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. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 58
Study Start Date: March 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pyridoxine plus prednisolone Drug: Pyridoxine plus prednisolone
Active Comparator: Prednisolone Drug: Prednisolone

  Eligibility

Ages Eligible for Study:   3 Months to 36 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828437

Contacts
Contact: Suvasini Sharma, DM sharma.suvasini@gmail.com

Locations
India
Lady Hardinge Medical College Recruiting
New Delhi, India
Contact: Suvasini Sharma, MD       sharma.suvasini@gmail.com   
Sponsors and Collaborators
Lady Hardinge Medical College
Investigators
Principal Investigator: Satinder Aneja, MD Lady Hardinge Medical College
  More Information

No publications provided

Responsible Party: Satinder Aneja, Director Professor and Head, Lady Hardinge Medical College
ClinicalTrials.gov Identifier: NCT01828437     History of Changes
Other Study ID Numbers: PYRIPREDIS
Study First Received: April 7, 2013
Last Updated: April 9, 2013
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Spasm
Spasms, Infantile
Brain Diseases
Central Nervous System Diseases
Epilepsy
Epilepsy, Generalized
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Pyridoxal
Pyridoxine
Vitamin B 6
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Growth Substances
Hormones

ClinicalTrials.gov processed this record on November 20, 2014