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    Summary
    EudraCT Number:2010-020797-41
    Sponsor's Protocol Code Number:NEMO1(08NR26)
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-09-22
    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 ConcernedFinland - Fimea
    A.2EudraCT number2010-020797-41
    A.3Full title of the trial
    NEMO1: An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal seizures using Medication Off-patent.
    A.3.2Name or abbreviated title of the trial where available
    NEMO1: NEonatal Seizure treatment with Medication Off-patent (v1.0)
    A.4.1Sponsor's protocol code numberNEMO1(08NR26)
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOnly for Children Pharmaceuticals
    B.1.3.4Country
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    B.Sponsor: 2
    B.1.1Name of SponsorGreat Ormond Street Hospital for Children NHS Trust
    B.1.3.4Country
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBumetanide
    D.3.9.1CAS number 28395 03 1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 seizure in Hypoxic Ischaemic Encephalopathy.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.0
    E.1.2Level LLT
    E.1.2Classification code 10061197
    E.1.2Term Neonatal seizure in Hypoxic Ischaemic Encephalopathy
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate the optimal dose of bumetanide for use in neonatal seizures not responding to phenobarbitone (standard therapy). This optimum dose will be that which achieves the maximum seizure reduction with an acceptable safety profile.
    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 phenobarbitone alone

    • To assess whether bumetanide reduces the need for rescue medication.

    • To assess bumetanide as a diuretic in babies with hypoxic ischemic encephalopathy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female term baby with gestational age of 37-43 weeks and postnatal age <48 hours

    One or more of the following:
    o APGAR score < 5 at 5 mins.
    o Umbilical cord or first arterial blood sample pH < 7.1 or base deficit >16 mmol/L.
    o Postnatal resuscitation still required 10 minutes after birth

    Clinical evolving encephalopathy

    Received one dose of standard anticonvulsive therapy (phenobarbitone, 20mg/kg) for clinical or electrographic seizures.

    Electrographic seizures, more than cumulative 3 minutes over a period of 2 hours or ≥2 seizures with durations of 30 seconds each within a 2-hour window.

    Written informed consent of parent or guardian.

    EEG monitoring has commenced within the first 48 hours of birth.
    E.4Principal exclusion criteria
    Suspected or confirmed brain malformation, inborn error of metabolism, genetic syndrome, or major congenital malformation

    Congenital (in utero) infection (TORCH).

    Babies who have received diuretics such as furosemide or bumetanide in routine clinical management within the last 24 hours.

    Total serum bilirubin > 15 mg/dl (255 micromol/l) at inclusion.

    On any other anticonvulsive medication other than phenobarbitone or bolus of midazolam / pentobarbitone for intubation.

    Anuria/renal failure defined as serum creatinine > 200 micromol/l.

    Severe electrolyte depletion (Na <120 mmol/L, K <3.0 mmol/L)
    E.5 End points
    E.5.1Primary end point(s)
    Stage 1

    The optimal dose is defined as achieving effective seizure reduction:
    - Defined as reduction of electrographic seizure burden by >80% within 12 hours after bumetanide administration over a 2 hour epoch compared to a 2 hour epoch prior to Bumetanide administration.
    - No need for rescue AED within 48 hours

    Safety: acceptable safety profile
    - Absence of Suspected Unexpected Serious Adverse Reactions (SUSARs)
    - Serious Adverse Reactions (SAR) which are at least probably related in <10%
    - Clinically acceptable frequency of adverse reactions
    * Severe hypokalaemia (<2.8mmol/l) and/or ECG changes in <10%
    * Severe dehydration (weight loss >10% over 24 hours with hypotension) in <10%

    Stage 2
    PK measurements (bumetanide at the optimal dose)
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    The end of the interventional phase (treatment phase) is defined as the last baby's hearing test.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.4Infants 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
    The study population are term babies with a postnatal age of less than 48 hours. Therefore parental consent will be sought.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state7
    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)
    The intervention will only be administered according to the protocol and for the times stated. The IMP is intended for acute seizures in neonates and therefore long term provision of this treatment is not applicable in this case.

    If a baby subsequently develops secondary epilepsy due to birth hypoxia other anti-epileptic drugs (AEDs) would be indicated (not bumetanide).
    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 Decision2010-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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