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    Summary
    EudraCT Number:2015-002756-27
    Sponsor's Protocol Code Number:N01349
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-03-28
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-002756-27
    A.3Full title of the trial
    A multicenter, open-label, single-arm study to evaluate the pharmacokinetics, efficacy, and safety of brivaracetam in neonates with repeated electroencephalographic seizures
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the pharmacokinetics, efficacy, and safety of brivaracetam in newborns with repeated electroencephalographic seizures.
    A.3.2Name or abbreviated title of the trial where available
    PETITE
    A.4.1Sponsor's protocol code numberN01349
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/048/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUCB Biopharma SPRL
    B.1.3.4CountryBelgium
    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 supportUCB Biopharma SPRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number004902173481515
    B.5.5Fax number004902173481572
    B.5.6E-mailclinicaltrials@ucb.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 Yes
    D.2.1.1.1Trade name Briviact
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBrivaracetam
    D.3.2Product code ucb 34714
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNBRIVARACETAM
    D.3.9.2Current sponsor codebrv
    D.3.9.3Other descriptive name(2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide
    D.3.9.4EV Substance CodeSUB20383
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Briviact
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBriviact
    D.3.2Product code E139204
    D.3.4Pharmaceutical form Oral solution
    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 INNBRIVARACETAM
    D.3.9.3Other descriptive name(2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide
    D.3.9.4EV Substance CodeSUB25397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Electroencephalographic neonatal seizures
    E.1.1.1Medical condition in easily understood language
    Electroencephalographic neonatal seizures
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To evaluate the pharmacokinetics (PK) of brivaracetam (BRV) in neonates who have seizures that are
    not adequately controlled with phenobarbital (PB) treatment and to identify the optimum BRV dose
    (Exploratory Cohort) for the treatment of subjects enrolled into the Confirmatory Cohorts of this study
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of brivaracetam (BRV) in severe and nonsevere seizure burden (defined as
    total minutes of electroencephalographic neonatal seizures [ENS] per hour) in neonates with seizures that
    are not adequately controlled with phenobarbital (PB) treatment
    - To evaluate the short-term safety and tolerability of BRV in neonates
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Confirmation on video-electroencephalography (VEEG) of >= 2 minutes
    of cumulative
    electroencephalographic neonatal seizures (ENS), or >=3 identifiable
    ENS within the 2 hours prior to
    entering the Evaluation Period, despite receiving phenobarbital (PB) for
    the treatment of repeated seizures
    - Subject is male or female with an age at birth of at 34 weeks to less
    than 42 of gestational age (GA) and up to 28 days of postnatal age at the
    time of enrollment
    - Subject weighs at least 2.3 kg at the time of enrollment
    - Subjects with or without concomitant hypothermia treatment
    E.4Principal exclusion criteria
    Subject received antiepileptic drug (AED) treatment (other than the required 1 or 2 doses of
    phenobarbital (PB) [total therapeutic administered dose of 20 to 40mg/kg] for the treatment of repeated
    seizures) prior to entering the Evaluation Period.
    - Subject with seizures responding to PB (total therapeutic administered dose of 20 to 40mg/kg),
    pyridoxine treatment, or correction of metabolic disturbances (hypoglycemia, hypomagnesemia or
    hypocalcemia)
    - Subject has a poor prognosis for survival, as judged by the Investigator
    - Subject has 2x upper limit of normal (ULN) of any of the following: aspartate aminotransferase (AST),
    alanine aminotransferase (ALT), and alkaline phosphatase (ALP), according to the subject’s gestational
    age (GA) and the site’s normal range values for the respective GA
    - Subject has conjugated bilirubin levels >2mg/dL
    - Subject requires extra corporeal membrane oxygenation
    - Subject has seizures related to prenatal maternal drug use or drug withdrawal
    - Subject has known severe disturbance of hemostasis, as assessed by the Investigator
    E.5 End points
    E.5.1Primary end point(s)
    1. Plasma concentration of brivaracetam (BRV) 30-60 min after the BRV infusion on day 1
    2. Plasma concentration of brivaracetam (BRV) 2-4 hours after the BRV infusion on day 1
    3. Plasma concentration of brivaracetam (BRV) 8-12 hours after the BRV infusion on day 1
    4. Plasma concentration of the BRV metabolite ucb-42145 (acid) 30-60 min after the BRV infusion on
    day 1
    5. Plasma concentration of the BRV metabolite ucb-42145 (acid) 2-4 hours after the BRV infusion on
    day 1
    6. Plasma concentration of the BRV metabolite ucb-42145 (acid) 8-12 hours after the BRV infusion on
    day 1
    7. Plasma concentration of the BRV metabolite ucb-100406-1 (hydroxy) 30-60 min after the BRV
    infusion on day 1
    8. Plasma concentration of the BRV metabolite ucb-100406-1 (hydroxy) 2-4 hours after the BRV
    infusion on day 1
    9. Plasma concentration of the BRV metabolite ucb-100406-1 (hydroxy) 8-12 hours after the BRV
    infusion on day 1
    10. Plasma concentration of the BRV metabolite ucb-107092-1 (hydroxyacid) 30-60 min after the BRV
    infusion on day 1
    11. Plasma concentration of the BRV metabolite ucb-107092-1 (hydroxyacid) 2-4 hours after the BRV
    infusion on day 1
    12. Plasma concentration of the BRV metabolite ucb-107092-1 (hydroxyacid) 8-12 hours after the BRV
    infusion on day 1
    13. Area under the BRV plasma concentration time curve
    14. Distribution volume of BRV
    15. Plasma clearance of BRV
    16. Plasma concentration of the concomitant antiepileptic drug phenobarbital (PB)
    17. Plasma concentration of the concomitant antiepileptic drug phenytoin (PHT)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 4, 7, 10: 30-60 min after the BRV infusion on day 1
    2, 5, 8, 11: 2-4 hours after the BRV infusion on day 1
    3, 6, 9, 12: 8-12 hours after the BRV infusion on day 1
    13, 14, 15: Samples will be collected 30-60 min, 2-4 hours, and 8-12 hours after the BRV infusion on
    day 1 and potentially on day 2 for the exploratory cohort and on day 1 and day 2, or on day 1 and day 3,
    or on day 1 and day 4 for the confirmatory cohorts.
    16, 17: Samples will be collected 3 hours after the initial dose of BRV
    E.5.2Secondary end point(s)
    1. Percentage of responders to brivaracetam (BRV) treatment from Baseline to 3 hours after the initial
    BRV dose
    2. Percentage of subjects with at least 80% reduction in nonsevere seizure burden from Baseline to 3
    hours after the initial BRV treatment
    3. Percentage of subjects with at least 50% reduction in severe seizure burden from Baseline to 3 hours
    after the initial BRV treatment
    4. Absolute change in average seizure burden measured by continuous video-electroencephalography
    (VEEG) from Baseline to the end of the 96-hour Evaluation Period
    5. Percentage change in average seizure burden measured by continuous VEEG from Baseline to the end
    of the 96-hour Evaluation Period
    6. Percentage of BRV responders at the end of the 96-hour Evaluation Period
    7. Percentage of subjects who are seizure-free (100% reduction in seizure burden from Baseline) at 24
    hours following the start of initial BRV treatment, categorized by subjects with nonsevere or severe
    seizure burden at Baseline
    8. Time to reduction in seizure burden for BRV responders
    9. Percentage of Subjects with Seizure Freedom at the end of Down-Titration Period
    10. Percentage of Subjects with at least 50% reduction in electroencephalographic neonatal seizures
    (ENS) frequency per hour from Baseline to the end of the 96-hour Evaluation Period
    11. Percentage of subjects who are seizure-free by time interval over the 96-hour evaluation period
    12. Absolute change of clinical seizures correlated with continuous VEEG from Baseline to the end of
    the 96-hour Evaluation Period
    13. Absolute change of clinical seizures correlated with continuous VEEG by time interval over the 96-
    hour evaluation period
    14. Percentage of Subjects with clinical seizures correlated with continuous VEEG from Baseline to the
    end of the 96-hour Evaluation Period
    15. Percentage of Subjects with clinical seizures correlated with continuous VEEG by time interval over
    the 96-hour evaluation period
    16. Absolute change from Baseline in clinical seizure burden by time interval over the 96-hour
    evaluation period
    17. Percentage change from Baseline in clinical seizure burden by time interval over the 96-hour
    evaluation period
    18. Categorized percentage change from Baseline to the end of the 96-hour Evaluation Period in seizure
    burden
    19. Percentage of responders to BRV treatment by time interval over the 96-hour evaluation period
    20. Percentage of subjects who switch over from BRV to another antiepileptic drug (AED) during the 96-
    hour Evaluation Period
    21. Percentage of responders to other treatment from Baseline to the end of the 96-hour Evaluation
    Period
    22. Percentage of responders to other treatment by time interval over the 96-hour evaluation period
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 3: From Baseline to 3 hours after the initial BRV dose
    4, 5, 6, 10, 12, 14, 16, 17, 18, 19, 21, 22: From Baseline to the end of the 96-hour Evaluation Period
    13, 15: At each 3-hour interval from Baseline to the end of the 96-hour Evaluation Period
    8: From Baseline to the first timepoint when BRV responder criteria is met
    7: From Baseline to 24 hours after the initial BRV treatment
    9: From Baseline to the end of the end of the Down-Titration Period
    11: From 3 hours following the start of the initial BRV treatment to the end of the 96-hour Evaluation
    Period
    20: During the 96-hour Evaluation Period
    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 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) 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 No
    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
    Last Subject Last Visit (LSLV)
    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 months1
    E.8.9.1In the Member State concerned days24
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days24
    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: 42
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 10
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 30
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 2
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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
    Neonates from 34 weeks to less than 42 weeks of gestational age (GA) at birth and up to 28 days of postnatal age at the time of enrollment.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 42
    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)
    All subjects who participate in the Brivaracetam (BRV) Extension Period must be offered entry into a
    long-term follow-up study, if they meet the eligibility criteria.
    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 Decision2017-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-12-23
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