Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

• ClinicalTrials.gov Identifier: NCT01575639
• Recruitment Status: Completed
• First Posted: April 11, 2012
• Last Update Posted: April 9, 2013
• Sponsor: Lady Hardinge Medical College
• Information provided by (Responsible Party): Satinder Aneja, Lady Hardinge Medical College

Tracking Information

• First Submitted Date: April 9, 2012
• First Posted Date: April 11, 2012
• Last Update Posted Date: April 9, 2013
• Study Start Date: February 2012
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 10, 2012): Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 . [ Time Frame: 14 days ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: April 10, 2012): Proportion of children with adverse effects [ Time Frame: 14 days ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prednisolone in Infantile Spasms- High Dose Versus Usual Dose
• Official Title: Randomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms.
• 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Infantile Spasms
• West Syndrome

Intervention

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

Study Arms

• Experimental: High dose
  Oral Prednisolone will be given at dose of 4 mg/kg/day for 14 days
  Intervention: Drug: Oral prednisolone
• Active Comparator: Usual dose
  Oral prednisolone will be given at dose of 2 mg/kg/day for 14 days
  Intervention: Drug: Oral prednisolone

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 7, 2013): 63
• Original Estimated Enrollment (submitted: April 10, 2012): 60
• Actual Study Completion Date: March 2013
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 3 Months to 24 Months (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT01575639
• Other Study ID Numbers: PREDIS
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Satinder Aneja, Lady Hardinge Medical College
• Original Responsible Party: Same as current
• Current Study Sponsor: Lady Hardinge Medical College
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Satinder Aneja, MD; Lady Hardinge Medical College

• PRS Account: Lady Hardinge Medical College
• Verification Date: April 2013