Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

This study has been completed.
Information provided by (Responsible Party):
Satinder Aneja, Lady Hardinge Medical College Identifier:
First received: April 9, 2012
Last updated: April 7, 2013
Last verified: April 2013
Infantile spasms comprise a difficult to treat type of epilepsy in young children. Hormonal treatment, i.e. Prednisolone and ACTH are considered the treatment of choice. There is no consensus on the dosage of Prednisolone required for the treatment of infantile spasms. Recent data has shown that a high dose (4 mg/kg/day) may be more efficacious than the usual dose (2 mg/kg/day). However, there are no randomized controlled trials comparing these doses. A higher steroid dose may also be associated with more side effects. Therefore, this study was planned to compare the efficacy and tolerability of the high dose versus the usual dose in children with infantile spasms, in a randomized open-label trial design

Condition Intervention Phase
Infantile Spasms
West Syndrome
Drug: Oral prednisolone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms.

Resource links provided by NLM:

Further study details as provided by Lady Hardinge Medical College:

Primary Outcome Measures:
  • Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 . [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of children with adverse effects [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 63
Study Start Date: February 2012
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High dose
Oral Prednisolone will be given at dose of 4 mg/kg/day for 14 days
Drug: Oral prednisolone
Dose will be different in the two groups. the high dose group will receive 4 mg/kg/day. The usual dose group will receive 2 mg/kg/day
Active Comparator: Usual dose
Oral prednisolone will be given at dose of 2 mg/kg/day for 14 days
Drug: Oral prednisolone
Dose will be different in the two groups. the high dose group will receive 4 mg/kg/day. The usual dose group will receive 2 mg/kg/day


Ages Eligible for Study:   3 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

- Children aged 3 months to 2 years presenting with epileptic spasms (at least 1 cluster/day) with EEG evidence of hypsarrhythmia or its variants

Exclusion Criteria:

  1. Children with active systemic illness
  2. Children with evidence of active tuberculosis
  3. Severe Acute Malnutrition ad defined by WHO (visible wasting/Mid Upper Arm Circumference < 11 cm/pedal edema/Weight for height < 3 SD)
  4. Children with recurrent illness/chronic systemic illness
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Please refer to this study by its identifier: NCT01575639

Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital
New Delhi, Delhi, India, 110001
Sponsors and Collaborators
Lady Hardinge Medical College
Principal Investigator: Satinder Aneja, MD Lady Hardinge Medical College
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Satinder Aneja, Director Professor, Lady Hardinge Medical College Identifier: NCT01575639     History of Changes
Other Study ID Numbers: PREDIS 
Study First Received: April 9, 2012
Last Updated: April 7, 2013
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Spasms, Infantile
Brain Diseases
Central Nervous System Diseases
Epilepsy, Generalized
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protective Agents processed this record on May 26, 2016