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    Summary
    EudraCT Number:2010-020797-41
    Sponsor's Protocol Code Number:NEMO1-08NR26
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-09-10
    Trial 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 ConcernedIreland - HPRA
    A.2EudraCT number2010-020797-41
    A.3Full title of the trial
    NEMO-1: An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal seizure using Medication Off-patent.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NEMO is an EU FP7 funded project that will be the largest multicentered European study of neonatal seizures and their treatment. The aim of the project is to develop a safe and effective antiepileptic drug (AED) regimen for newborn babies with seizures. Seizures are the most common neurological emergency in the neonatal period and require prompt diagnosis and treatment. The project will evaluate the safety and efficacy of bumetanide in combination with phenobarbitone for seizure control
    A.3.2Name or abbreviated title of the trial where available
    NEMO1
    A.4.1Sponsor's protocol code numberNEMO1-08NR26
    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 SponsorOnly for Children Pharmaceuticals
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEuropean Call for Health FP7-HEALTH-2009-4.2-1
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOnly for Children Pharmacueticals
    B.5.2Functional name of contact pointAlice Nolla
    B.5.3 Address:
    B.5.3.1Street AddressInstitut Villemin, 10 Avenue de Verdun
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailalice.nolla@o4cp.com
    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 No
    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.3.1Product nameBumetanide 0.2mg/ml solution for IV administration
    D.3.2Product code bumetanide
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Neonatal Seizures in Hypoxic Ischemic Encephalopathy
    E.1.1.1Medical condition in easily understood language
    Seizures in the newborn following a birth asphxia
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10061197
    E.1.2Term Neonatal seizures
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Stage 1
    • To estimate the optimal dose of bumetanide for the treatment of neonatal seizures not responding to the first dose phenobarbitone. This optimum dose will be that which achieves the maximum seizure reduction with an acceptable safety profile when used in addition to standard therapy (second dose of phenobarbitone) in > 50% of patients

    Stage 2
    • To determine the pharmacokinetics of bumetanide when given at the optimal dose as an add-on to phenobarbitone in babies with HIE and seizures not controlled by phenobarbitone
    E.2.2Secondary objectives of the trial
    • To assess the feasibility of neonatal seizure treatment with bumetanide in babies with HIE and seizures that are not responding to a first dose of phenobarbitone.
    • To assess whether bumetanide reduces the need for rescue medication.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female term baby with gestational age of 37-43 weeks and postnatal age <48 hours
    2. One or more of the following:
    APGAR score < 5 at 5 mins.
    Umbilical cord or first arterial blood sample pH < 7.1 or base deficit >16 mmol/L.
    Postnatal resuscitation still required 10 minutes after birth
    3. Clinical evolving encephalopathy
    4. Received one dose of standard anticonvulsive therapy (phenobarbitone, 20mg/kg) for clinical or electrographic seizures.
    5. EEG: equal to or more than 3 min cumulative seizures, or 2 or more seizures of >30 sec duration over a 2 hr period within the first 48 hr of life and after administration of one standard (20mg/kg) dose of phenobarbitone
    6. Written informed consent of parent or guardian.
    7. EEG monitoring has commenced within the first 48 hours of birth
    E.4Principal exclusion criteria
    1. Suspected or confirmed brain malformation, inborn error of metabolism, genetic syndrome, or major congenial malformation
    2. Congenital (in utero) infection (TORCH) if known.
    3. Babies who have received diuretics such as furosemide or bumetanide in routine clinical management within the last 24 hours
    4. On any other anticonvulsive medication other than phenobarbitone or or bolus of midazolam / pentobarbitone for intubation.
    6. Severe electrolyte depletion (Na <120 mmol/L, K <3.0 mmol/L)
    E.5 End points
    E.5.1Primary end point(s)
    Stage 1
    Efficacy:
    1. Defined as reduction of electrographic seizure burden by ≥80% within hours 3 and 4 after the first bumetanide administration compared to the baseline; a 2 hour epoch immediately prior to the first Bumetanide administration
    2. No need for rescue AED within 48 hours

    Safety: acceptable safety profile defined as
    1. Absence of Suspected Unexpected Serious Adverse Reactions (SUSARs)
    2. Serious Adverse Reactions (SAR) which are at least probably related in <10%
    3. Clinically acceptable frequency of adverse reactions
    I. Severe hypokalaemia (<2.8mmol/l) and/or ECG changes in <10%
    II. Severe dehydration (dehydration with hypotension (mean BP< 35mmHg persistent > 1 hour) which requires inotropic support in <10%)
    Stage 2
    1. PK measurements (bumetanide at the optimal dose)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Stage 1
    Efficacy:
    1. Evaluated at hours 3 and 4 after the first bumetanide administration
    2. Need for rescue AED evaluated at 48 hours after the first bumetanide administration

    Safety: acceptable safety profile continuously evaluated during the trial

    Stage 2
    1. PK measurements (bumetanide at the optimal dose) analysis completed at the end of the trial.
    E.5.2Secondary end point(s)
    Stage 1
    1. PK measurements
    2. Overall seizure control within the first 24 hr after bumetanide administration evaluated after the end of trial

    Stage 2
    1. Safety of bumetanide in babies with HIE
    2. Overall seizure control within the first 24 hr after bumetanide administration evaluated after the end of trial
    E.5.2.1Timepoint(s) of evaluation of this end point
    Stage 1
    1. PK measurements analysis completed at the end of the trial.
    2. Overall seizure control within the first 24 hr after bumetanide administration evaluated after the end of trial

    Stage 2
    1. Safety of bumetanide in babies with HIE continuously evaluated during the trial
    2. Overall seizure control within the first 24 hr after bumetanide administration evaluated after the end of trial
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Active substance already used off label in clinical practice, trial is for new indication
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    Neurological Assessment
    Hearing test
    End of the interventional phase (treatment phase) defined as the hearing test of the last baby.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    E.8.9.2In all countries concerned by the trial months0
    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: 49
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 49
    F.1.1.4Infants and toddlers (28 days-23 months) No
    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
    Male or female term baby with gestational age of 37-43 weeks and postnatal age <48 hours
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 49
    F.4.2.2In the whole clinical trial 49
    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)
    Currently all Babies enrolled in HIE research studies in Cork University Maternity Hospital are routinely enrolled in a neurological follow up program at 2 and 5 years of age.
    On discharge from hospital a letter will be sent to the General Practitioner (GP) of each patient informing them of the involvement of their patient in the NEMO-1 study
    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 Decision2010-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-11-13
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