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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01828437 |
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Date of registration:
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07/04/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Addition of Pyridoxine to Prednisolone in Infantile Spasms
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Scientific title:
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Addition of Pyridoxine to Prednisolone in the Treatment of Infantile Spasms: A Randomized Controlled Trial |
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Date of first enrolment:
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November 2012 |
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Target sample size:
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62 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01828437 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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India
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Contacts
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Name:
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Satinder Aneja, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lady Hardinge Medical College |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age in 3months-3years.
2. Presence of epileptic spasms (1 or more clusters per day) with EEG evidence of
hypsarrythmia or its variants.
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Exclusion Criteria:
1. Children with active systemic illness
2. Children with evidence of active tuberculosis
3. Severe Acute Malnutrition (standard deviation scores below median weight for height)
4. Children with recurrent illness/chronic systemic illness
5. Prior treatment of pyridoxine, steroid, or ACTH.
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Age minimum:
3 Months
Age maximum:
36 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Infantile Spasms
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Intervention(s)
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Drug: Pyridoxine plus prednisolone
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Drug: Prednisolone
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Primary Outcome(s)
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Proportion of children who achieved complete cessation spasm for at least 48 hours as per parental reports at the end of 2 weeks in both the groups.
[Time Frame: 2 weeks]
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Secondary Outcome(s)
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• Proportion of children who achieved more than 50 % reduction of clinical spasms as per parental reports at the end of 2 weeks
[Time Frame: 2 weeks]
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Secondary ID(s)
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PYRIPREDIS
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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