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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 5 June 2018
Main ID:  EUCTR2006-000788-27-DE
Date of registration: 11/06/2010
Prospective Registration: Yes
Primary sponsor: Royal United Hospital Bath NHS Trust
Public title: International Collaborative Study of a type of epilepsy called Infantile Spasms
Scientific title: International Collaborative Infantile Spasms Study (ICISS) - ICISS
Date of first enrolment: 23/09/2010
Target sample size: 410
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000788-27
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 3
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
Australia Germany New Zealand Switzerland United Kingdom
Contacts
Name: ICISS Trial Office-Childrens Centre   
Address:  Combe Park BA1 3NG Bath United Kingdom
Telephone:
Email: iciss@ruh-bath.swest.nhs.uk
Affiliation:  Royal United Hospital Bath NHS Trust
Name: ICISS Trial Office-Childrens Centre   
Address:  Combe Park BA1 3NG Bath United Kingdom
Telephone:
Email: iciss@ruh-bath.swest.nhs.uk
Affiliation:  Royal United Hospital Bath NHS Trust
Key inclusion & exclusion criteria
Inclusion criteria:
The clinical features of Infantile Spasms confirmed by the consultant in charge or his/her nominated deputy.

An EEG that is hypsarrhythmic or similar, compatible with the diagnosis of Infantile Spasms.

Signed informed consent has been given.

Are the trial subjects under 18? yes
Number of subjects for this age range: 410
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
More than 72 hours has elapsed since the EEG was performed.

More than 72 hours has elapsed since the clinical features were confirmed.

Age less than two months or greater than one year and two months.

A diagnosis or high risk of tuberous sclerosis (known affected parent, previously diagnosed cardiac rhabdomyoma, hypomelanic macules, forehead fibrous plaque, shagreen patch, retinal phakoma or known polycystic kidneys).

Previous treatment for infantile spasms other than a therapeutic trial of pyridoxine to exclude pyridoxine dependent seizures. Note - previous treatment for other seizure types is not a reason for exclusion.

Previous treatment (within the last 28 days) with vigabatrin or hormonal treatments.

A contraindication to vigabatrin or hormonal treatments. A risk of a visual field defect is not considered a contraindication.

A lethal or potentially lethal condition, other than infantile spasms, with a risk of death before 18 months of age.

Doubt about the ability of the parents or guardians to know when the spasms stop.This is likely to include parents known to be intravenous drug abusers.

Unavailable for follow up to 18 months of age.

Those enrolled in a concurrent trial that is still in the active phase.

The language ability of the parents or guardians is such that they may not understand what is being requested of them.

The language ability of the parents or guardians is such that it will not be possible to undertake the Vineland assessment.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Infantile spasms are a rare severe form of epilepsy affecting approx 1 in 2,250 infants, usually under the age of 1 year. Affected infants have a very abnormal EEG and a poor prognosis for subsequent epilepsy and neuro-development. There is a high risk of underlying neurological disease that independently causes delayed development and other seizure disorders. There is a high risk of a poor outcome even when there is no other detectable underlying neurological disorder.
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: SABRIL
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: Vigabatrin
CAS Number: 60643-86-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Trade Name: Synacthen Depot
Pharmaceutical Form: Injection
INN or Proposed INN: Tetracosactide Acetate
CAS Number: 16960-16-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-

Trade Name: Decortin H
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolone
CAS Number: 125-02-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)
Main Objective: The aim of this study is to examine if combining hormonal treatment and vigabatrin is better at controlling infantile spasms and at helping development at 18 months of age than taking a hormonal treatment alone.
Primary end point(s): 1. The primary early outcome will be the cessation of spasms. Cessation of spasms is defined as no witnessed spasms on and between Days 14 to 42.
2. The primary late outcome will be development at 18 months of age and will be assessed by the validated Vineland Adaptive Behaviour Scales (VABS).
Secondary Objective: We also wish to investigate adverse reactions, time to elimination of spasms, developmental outcome at 42 months of age, epilepsy outcomes at 18 and 42 months of age and numbers of infants with elimination of both spasms and the EEG appearance with which it is associated.We will also compare the efficacy of the two hormonal treatments in those infants receiving these treatments alone and through random allocation.
Timepoint(s) of evaluation of this end point: 18 months of age
Secondary Outcome(s)
Secondary end point(s): Electroclinical response
Adverse Reactions
Development at 42 months of age
Timepoint(s) of evaluation of this end point: Electroclinical response - 49 days
Adverse reactions - 4 months
Development - 42 months of age
Secondary ID(s)
2006-000788-27-GB
ISRCTN54363174
RD01273
Source(s) of Monetary Support
Bath Unit for Research in Paediatrics
Bronner/Bender Stiftung
Castang Foundation
NIHR
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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