Randomized Clinical Trial on Prednisolone Vs ACTH for the treatment of Infantile Spasms

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2010/010
• Date of registration: 01/11/2010
• Primary sponsor: Department of Paediatrics
• Public title: Randomized Clinical Trial on Prednisolone Vs ACTH for the treatment of Infantile Spasms
• Scientific title: Randomized Clinical Trial on Prednisolone Vs ACTH for the treatment of Infantile Spasms
• Date of first enrolment: 1/11/2010
• Target sample size: 136
• Recruitment status: Recruiting
• URL: http://www.slctr.lk/trial_details.asp?reg_id={787D06AF-E596-43DE-89A1-1C84E635DEBC}
• Study type: Interventional
• Study design: A single centre, randomized, parallel-group, open labeled clinical trial

Countries of recruitment

Sri Lanka

Contacts

• Name: Dr. Jithangi Wanigasinghe
• Affiliation: Senior Lecturer and Consultant Paediatric Neurologist

• Name: Dr. Jithangi Wanigasinghe
• Affiliation: Senior Lecturer and Consultant Paediatric Neurologist

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Infantile Spasms

Intervention(s)

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.

Primary Outcome(s)

1. Spasm freedom/ spasm control- assessed using the spasm diary on day 14

2. Number of days taken for achieving spasm control

3. Comparison of the pre and post treatment EEGs for improvement (the repeat EEG will be performed during day 14-18)

4. Tolerance of the treatment arm without any complications/ need for withdrawal of therapy- will be assessed from the checklist of side effects

5. Developmental assessment at 6 and 12 months after initiating treatment.

Secondary Outcome(s)

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.

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Self-funded