Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

NCT01575639 | Completed Phase 3

• 1 other identifier: PREDIS
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infantile Spasms; West Syndrome

Outcome Measures

Primary Outcomes (1)

• Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 .

  14 days

Secondary Outcomes (1)

• Proportion of children with adverse effects

  14 days

Study Arms (2)

High dose

EXPERIMENTAL

Oral Prednisolone will be given at dose of 4 mg/kg/day for 14 days

Drug: Oral prednisolone

Usual dose

ACTIVE COMPARATOR

Oral prednisolone will be given at dose of 2 mg/kg/day for 14 days

Drug: Oral prednisolone

Interventions

Oral prednisolone DRUG

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

High dose; Usual dose

Eligibility Criteria

• Age: 3 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Children with active systemic illness
• Children with evidence of active tuberculosis
• Severe Acute Malnutrition ad defined by WHO (visible wasting/Mid Upper Arm Circumference \< 11 cm/pedal edema/Weight for height \< 3 SD)
• Children with recurrent illness/chronic systemic illness

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

Study Sites (1)

Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital

New Delhi, National Capital Territory of Delhi, 110001, India

Location

Related Publications (1)

• Chellamuthu P, Sharma S, Jain P, Kaushik JS, Seth A, Aneja S. High dose (4 mg/kg/day) versus usual dose (2 mg/kg/day) oral prednisolone for treatment of infantile spasms: an open-label, randomized controlled trial. Epilepsy Res. 2014 Oct;108(8):1378-84. doi: 10.1016/j.eplepsyres.2014.06.019. Epub 2014 Jul 5.

  PMID: 25048310 DERIVED

MeSH Terms

Conditions

Spasms, Infantile

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Satinder Aneja, MD

  Lady Hardinge Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Professor

Study Record Dates

• First Submitted: April 9, 2012
• First Posted: April 11, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 9, 2013

Record last verified: 2013-04

Locations

IN (1)