Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

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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
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Proportion of children with adverse effects

Condition

Infantile Spasms

Intervention

Oral prednisolone

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

63

Start Date

February 2012

Completion Date

March 2013

Primary Completion Date

February 2013

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
      

Gender

All

Ages

3 Months - 24 Months

Accepts Healthy Volunteers

No

Contacts

Satinder Aneja, MD, , 

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT01575639

Organization ID

PREDIS


Responsible Party

Principal Investigator

Study Sponsor

Lady Hardinge Medical College


Study Sponsor

Satinder Aneja, MD, Principal Investigator, Lady Hardinge Medical College


Verification Date

April 2013