Condition category
Nervous System Diseases
Date applied
06/02/2006
Date assigned
03/04/2006
Last edited
18/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.iciss.org.uk

Contact information

Type

Scientific

Primary contact

Prof John Osborne

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RD01273

Study information

Scientific title

International Collaborative Infantile Spasms Study

Acronym

ICISS

Study hypothesis

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

South West Research Ethics Committee, 20/04/2006, ref: 06/MRE06/21

Study design

Randomised partial blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Patient information material can be found on the website at http://www.iciss.org.uk

Condition

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 names

1. Hormonal treatment (either prednisolone or tetracosactide depot) alone
2. Vigabatrin

Primary outcome measures

1. 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 measures

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

Overall trial start date

01/06/2006

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

410

Participant 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

Recruitment start date

01/06/2006

Recruitment end date

31/12/2014

Locations

Countries of recruitment

New Zealand, United Kingdom

Trial participating centre

Royal United Hospital
Bath
BA1 3NG
United Kingdom

Sponsor information

Organisation

Royal United Hospital Bath NHS Trust (UK)

Sponsor details

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

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Castang Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27838190

Publication citations

Additional files

Editorial Notes

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