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Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01575639
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : April 9, 2013
Sponsor:
Information provided by (Responsible Party):
Satinder Aneja, Lady Hardinge Medical College

Study Description
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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

Condition or disease Intervention/treatment Phase
Infantile Spasms West Syndrome Drug: Oral prednisolone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : February 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Cramps

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 . [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Proportion of children with adverse effects [ Time Frame: 14 days ]

Eligibility Criteria
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Ages Eligible for Study:   3 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575639


Locations
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India
Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital
New Delhi, Delhi, India, 110001
Sponsors and Collaborators
Lady Hardinge Medical College
Investigators
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Principal Investigator: Satinder Aneja, MD Lady Hardinge Medical College
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Satinder Aneja, Director Professor, Lady Hardinge Medical College
ClinicalTrials.gov Identifier: NCT01575639    
Other Study ID Numbers: PREDIS
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: April 9, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Spasm
Spasms, Infantile
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
 Epileptic Syndromes
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents