International Collaborative Study of a type of epilepsy called Infantile Spasms

• 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
• Affiliation: Royal United Hospital Bath NHS Trust

• Name: ICISS Trial Office-Childrens Centre
• 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)

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.

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).

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.

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)

RD01273

ISRCTN54363174

2006-000788-27-GB

Source(s) of Monetary Support

Bath Unit for Research in Paediatrics

Castang Foundation

NIHR

Bronner/Bender Stiftung