Home » Trials » SLCTR/2010/010
Randomized Clinical Trial on Prednisolone Vs ACTH for the treatment of Infantile Spasms
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SLCTR Registration Number
SLCTR/2010/010
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Randomized Clinical Trial on Prednisolone Vs ACTH for the treatment of Infantile Spasms
Public Title of Trial
Randomized Clinical Trial on Prednisolone Vs ACTH for the treatment of Infantile Spasms
Disease or Health Condition(s) Studied
Infantile spasms
Scientific Acronym
None
Public Acronym
None
Brief title
Outcome of steroid therapy on infantile spasms
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC-10-081 (Ethics Review Committee, Faculty of Medicine, Colombo)
What is the research question being addressed?
1.Which of the two therapeutic formulations (oral prednisolone and intramuscular ACTH) at high doses is more effective in the treatment of infantile spasms 2. Patients in which treatment arm has better developmental outcome?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
They will undergo detailed evaluation for aetiology, development and a digital electroencephalogram with video monitoring will be performed. Following randomization they will be commenced on the therapy consisting of oral prednisolone or intramuscular adrenocorticotropin homone, and will be monitored closely for side effects
Inclusion criteria
• infants newly diagnosed with infantile spasms • who have not been commenced on any treatment for infantile spasms • between the ages of 1 month and 12 months
Exclusion criteria
• Patients previously treated for infantile spasms • Patients with tuberous sclerosis • Patients with any contraindication to the use of steroids
Primary outcome(s)
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1.
Spasm freedom/ spasm control- assessed using the spasm diary on day 14 |
[ Outcome measure on day 14 developmental assessment at 6 months and 12 months ] |
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2.
Number of days taken for achieving spasm control |
[ Outcome measure on day 14 developmental assessment at 6 months and 12 months ] |
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3.
Comparison of the pre and post treatment EEGs for improvement (the repeat EEG will be performed during day 14-18) |
[ Outcome measure on day 14 developmental assessment at 6 months and 12 months ] |
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4.
Tolerance of the treatment arm without any complications/ need for withdrawal of therapy- will be assessed from the checklist of side effects |
[ Outcome measure on day 14 developmental assessment at 6 months and 12 months ] |
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5.
Developmental assessment at 6 and 12 months after initiating treatment. |
[ Outcome measure on day 14 developmental assessment at 6 months and 12 months ] |
Secondary outcome(s)
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1.
Safety of the medication will be assessed as secondary outcome. This will be defined as a) number who develop serious adverse effects and B) number who had to take off the protocol due to ADRs. Method of assessment: After the first 48 hours blood pressure, serum electrolytes and urinary sugars will be monitored in all. If BP is normal this will be rechecked on day 7 and day 14. At end of the 14 days of therapy a research assistant who will review the patient will go through a check list to document the side effects experienced. All adverse effects will be classified according to definitions used for phamacovigilence. |
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Target number/sample size
136
Countries of recruitment
Sri Lanka
Anticipated start date
2010-11-01
Anticipated end date
2012-11-01
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Self-funded
Regulatory approvals
Status
Approved
Date of Approval
2010-08-26
Approval number
EC-10-081
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Jithangi Wanigasinghe
Senior Lecturer and Consultant Paediatric Neurologist
Department of Paediatrics, Faculty of Medicine, University of Colombo
0777313914
jithwani@yahoo.com
Contact Person for Public Queries
Dr. Jithangi Wanigasinghe
Senior Lecturer and Consultant Paediatric Neurologist
Department of Paediatrics, Faculty of Medicine, University of Colombo
0777313914
jithwani@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
