International Collaborative Infantile Spasms Study

ISRCTN	ISRCTN54363174
DOI	https://doi.org/10.1186/ISRCTN54363174
Protocol serial number	RD01273
Sponsor	Royal United Hospital Bath NHS Trust (UK)
Funders	Castang Foundation (UK), Bath Unit for Research in Paediatrics (BURP) (UK), National Health Service (NHS) Research and Development Programme (UK)

Submission date: 06/02/2006
Registration date: 03/04/2006
Last edited: 24/09/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof John Osborne
Scientific

Children's Centre
Royal United Hospital
Combe Park
Bath
BA1 3NG
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised partial blind controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	International Collaborative Infantile Spasms Study
Study acronym	ICISS
Study objectives	The purpose of the trial is to test the following two primary hypotheses: 1. In infantile spasms (including West syndrome), combined treatment with both hormonal treatment and vigabatrin is superior to hormonal treatment alone in eliminating spasms 2. In infantile spasms (including West syndrome), combined treatment with both hormonal treatment and vigabatrin results in better development at 18 months of age than hormonal treatment alone. This effect may only be seen in those infants with no identified aetiology for their spasms. Secondary hypotheses in those infants allocated combined treatment compared to those allocated hormonal treatment alone: 1. Time to elimination of spasms will be shorter 2. Developmental outcome at 42 months of age will be better; this effect may only be seen in those infants with no identified aetiology for their spasms 3. Epilepsy outcomes at 18 and 42 months of age will be better 4. Number of infants with elimination of spasms and disappearance of the electroencephalogram (EEG), appearance with which it is associated will be better. Those randomly allocated their hormonal treatment will also be compared as above.
Ethics approval(s)	South West Research Ethics Committee, 20/04/2006, ref: 06/MRE06/21
Health condition(s) or problem(s) studied	Infantile spasms including West syndrome
Intervention	Hormonal treatment (either prednisolone or tetracosactide depot) alone versus combination of hormonal treatment and vigabatrin
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	1. Hormonal treatment (either prednisolone or tetracosactide depot) alone 2. Vigabatrin
Primary outcome measure(s)	1. The main early outcome will be the cessation of spasms 2. The main late outcome will be development at 18 months of age
Key secondary outcome measure(s)	1. Absence of spasms on days 13 and 14 2. Electro-clinical outcome 3. Extended electro-clinical outcome 4. The number of consecutive days free of spasms preceding and including day 14 5. Adverse reactions 6. Epilepsy outcome at 18 months of age 7. Development at 42 months of age 8. Epilepsy outcome at 42 months of age
Completion date	31/12/2014

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	410
Key inclusion criteria	The clinical features of infantile spasms confirmed by the consultant in charge or his/her nominated deputy and an EEG that is hypsarhythmic or similar, compatible with the diagnosis of infantile spasms
Key exclusion criteria	1. More than 72 hours has elapsed since the EEG was performed 2. More than 72 hours has elapsed since the clinical features were confirmed 3. Age less than two months or greater than one year and two months 4. A diagnosis or high risk of tuberous sclerosis 5. Known affected parent, previously diagnosed cardiac rhabdomyoma, hypomelanic macules, forehead fibrous plaque, shagreen patch, retinal phakoma or known polycystic kidneys 6. Previous treatment for infantile spasms other than a therapeutic trial of pyridoxine to exclude pyridoxine dependent seizures. Previous treatment for other seizure types is not a reason for exclusion. 7. Previous treatment (within the last 28 days) with vigabatrin or hormonal treatments 8. A contraindication to vigabatrin or hormonal treatments 9. A lethal or potentially lethal condition, other than infantile spasms, with a risk of death before 18 months of age 10. Doubt about the ability of the parents or guardians to know when the spasms stop 11. Unavailable for follow up to 18 months of age 12. Those enrolled in a concurrent trial that is still in the active phase 13. The language ability of the parents or guardians is such that they may not understand what is being requested of them 14. The language ability of the parents or guardians is such that it will not be possible to undertake the Vineland assessment
Date of first enrolment	01/06/2006
Date of final enrolment	31/12/2014

Locations

Countries of recruitment

United Kingdom
England
New Zealand

Study participating centre

Royal United Hospital

Bath
BA1 3NG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results up to day 42	01/01/2017		Yes	No
Results article	results of 18-month follow-up	01/10/2018		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

24/09/2018: Publication reference added.
14/11/2016: Publication reference added.
07'05/2008: The overall trial end date was changed from 31/05/2012 to 31/12/2014.