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    Summary
    EudraCT Number:2006-000788-27
    Sponsor's Protocol Code Number:RD01273
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-11
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2006-000788-27
    A.3Full title of the trial
    International Collaborative Infantile Spasms Study (ICISS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    International Collaborative Study of a type of epilepsy called Infantile Spasms
    A.3.2Name or abbreviated title of the trial where available
    ICISS
    A.4.1Sponsor's protocol code numberRD01273
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN54363174
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRoyal United Hospital Bath NHS Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCastang Foundation
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportNIHR
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportBath Unit for Research in Paediatrics
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportBronner/Bender Stiftung
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRoyal United Hospital Bath NHS Trust
    B.5.2Functional name of contact pointICISS Trial Office-Childrens Centre
    B.5.3 Address:
    B.5.3.1Street AddressCombe Park
    B.5.3.2Town/ cityBath
    B.5.3.3Post codeBA1 3NG
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailiciss@ruh-bath.swest.nhs.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name SABRIL
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI AVENTIS
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for oral solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVigabatrin
    D.3.9.1CAS number 60643-86-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Synacthen Depot
    D.2.1.1.2Name of the Marketing Authorisation holderSigma-Tau
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTetracosactide Acetate
    D.3.9.1CAS number 16960-16-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Decortin H
    D.2.1.1.2Name of the Marketing Authorisation holderMerck
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisolone
    D.3.9.1CAS number 125-02-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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.
    E.1.1.1Medical condition in easily understood language
    Infantile spasms are a rare severe form of epilepsy affecting approx 1 in 2,250 infants, usually under the age of 1 year. There is a high risk of poor development and other epilepsy.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary 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).
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 months of age
    E.5.2Secondary end point(s)
    Electroclinical response
    Adverse Reactions
    Development at 42 months of age
    E.5.2.1Timepoint(s) of evaluation of this end point
    Electroclinical response - 49 days
    Adverse reactions - 4 months
    Development - 42 months of age
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    This is a pragmatic trial.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA180
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Germany
    New Zealand
    Switzerland
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Drug regulatory approval until all participants finish mandatory treatment with any IMP. The initial estimate until this point 5 years 4 months.
    Ethics approval until developmental and epilepsy follow up is complete The initial estimate until this end point 7 years 6 months.
    We presume the comment below refers to visits during the active phase of the trial where the protocol shows mandatory treatment. We presume this does not include developmental follow up after mandatory treatment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 410
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 410
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Infants. The legal representatives will be asked to give consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 410
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No different from expected normal treatment. In Germany, all three IMPs are licensed medicines. They are all licenced for use in epilepsy and or infantile spasms.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-31
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