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ICISS is an international multicentre randomised parallel group trial investigating the medical treatment of Infantile Spasms (including West syndrome).
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ICISS involves centres in Europe, Australia and New Zealand.
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ICISS will compare hormonal treatment (either tetracosactide depot or prednisolone) and vigabatrin given together (combined treatment) to hormonal treatment alone.
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ICISS builds on the United Kingdom Infantile Spasms Study (UKISS), the infrastructure that supported it and Westdelphi, the international consensus on definitions and outcomes in Infantile Spasms (all research co-ordinated from Bath, UK).
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The main early outcome is control of spasms.
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The main late outcome is developmental progress at 18 months of age.
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Wherever possible, the infant’s epilepsy and developmental outcome will also be assessed at 42 months of age.
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Permission will be obtained to approach the families to request new ethical consent to reassess the infant’s development and epilepsy later in childhood, if worthwhile.
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Allocation of treatments was performed via this website.
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Recruitment began in 2007 and ended on 30 May 2014
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377 patients have been recruited.
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The formal end date of the study was 31 December 2017.
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Results from the trial have been published in The Lancet Neurology and The Lancet Child and Adolescent Heath.
