International Collaborative Infantile Spasms Study
| 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
Contact information
Prof John Osborne
Scientific
Scientific
Children's Centre
Royal United Hospital
Combe Park
Bath
BA1 3NG
United Kingdom
Study information
| Study design | Randomised partial blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Patient information material can be found on the website at http://www.iciss.org.uk |
| Scientific title | International Collaborative Infantile Spasms Study |
| 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(s) | South West Research Ethics Committee, 20/04/2006, ref: 06/MRE06/21 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 1. Hormonal treatment (either prednisolone or tetracosactide depot) alone 2. Vigabatrin |
| Primary outcome measure | 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 study start date | 01/06/2006 |
| Overall study end date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 410 |
| 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 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
- England
- New Zealand
- United Kingdom
Study participating centre
Royal United Hospital
Bath
BA1 3NG
United Kingdom
BA1 3NG
United Kingdom
Sponsor information
Royal United Hospital Bath NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Alistair Taylor
Manager Research and Development
Royal United Hospital
Combe Park
Bath
BA1 3NG
England
United Kingdom
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
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.
