ISRCTN ISRCTN54363174
DOI https://doi.org/10.1186/ISRCTN54363174
Secondary identifying numbers RD01273
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

Not provided at time of registration

Study website

Contact information

Prof John Osborne
Scientific

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

Study information

Study designRandomised partial blind controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Patient information material can be found on the website at http://www.iciss.org.uk
Scientific titleInternational Collaborative Infantile Spasms Study
Study acronymICISS
Study hypothesisThe 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
ConditionInfantile spasms including West syndrome
InterventionHormonal treatment (either prednisolone or tetracosactide depot) alone versus combination of hormonal treatment and vigabatrin
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)1. Hormonal treatment (either prednisolone or tetracosactide depot) alone 2. Vigabatrin
Primary outcome measure1. The main early outcome will be the cessation of spasms
2. The main late outcome will be development at 18 months of age
Secondary outcome measures1. 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
Overall study start date01/06/2006
Overall study end date31/12/2014

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants410
Participant inclusion criteriaThe 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
Participant exclusion criteria1. 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
Recruitment start date01/06/2006
Recruitment end date31/12/2014

Locations

Countries of recruitment

  • England
  • New Zealand
  • United Kingdom

Study participating centre

Royal United Hospital
Bath
BA1 3NG
United Kingdom

Sponsor information

Royal United Hospital Bath NHS Trust (UK)
Hospital/treatment centre

c/o Dr Alistair Taylor
Manager Research and Development
Royal United Hospital
Combe Park
Bath
BA1 3NG
England
United Kingdom

ROR logo "ROR" https://ror.org/058x7dy48

Funders

Funder type

Government

Castang Foundation (UK)

No information available

Bath Unit for Research in Paediatrics (BURP) (UK)

No information available

National Health Service (NHS) Research and Development Programme (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

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.

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