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    Summary
    EudraCT Number:2006-006536-22
    Sponsor's Protocol Code Number:N01263
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-13
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2006-006536-22
    A.3Full title of the trial
    OPEN-LABEL, SINGLE-ARM, MULTICENTER,
    PHARMACOKINETIC, SAFETY, AND EFFICACY STUDY OF
    ADJUNCTIVE ADMINISTRATION OF BRIVARACETAM IN
    SUBJECTS FROM ≥1 MONTH TO <16 YEARS OLD WITH
    EPILEPSY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY OF ADJUNCTIVE ADMINISTRATION OF BRIVARACETAM IN
    SUBJECTS FROM ≥1 MONTH TO <16 YEARS OLD WITH EPILEPSY
    A.4.1Sponsor's protocol code numberN01263
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/049/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUCB Pharma SA
    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 Pharma SA
    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 pointCT Registries & 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 number+492173481515
    B.5.5Fax number+492173841572
    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 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 nameBrivaracetam
    D.3.2Product code ucb 34714
    D.3.4Pharmaceutical form 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 INNBRIVARACETAM
    D.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeucb 34714
    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 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: 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 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 nameBrivaracetam
    D.3.2Product code ucb 34714
    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.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeucb 34714
    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
    Localization-related, generalized or undetermined whether focal or generalized epileptic syndrome, according to ILAE classification
    E.1.1.1Medical condition in easily understood language
    Epilepsy
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10015037
    E.1.2Term Epilepsy
    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
    To characterize the steady-state PK of BRV and its metabolites in subjects from ≥1 month to
    <16 years of age, evaluate their relationship with physiological developmental variables, and
    develop dosing adaptations.
    E.2.2Secondary objectives of the trial
    • To document the short-term safety and tolerability of BRV
    • To gain preliminary information on the efficacy of BRV in children with various
    epileptic syndromes
    • To assess compliance to study drug oral solution
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the parent(s) or legal representative(s). In addition, a Consent form or a specific Assent form, where required, will be signed and dated by minors.
    2. Subject/parent(s)/legal representative(s) is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule or medication intake according to the judgment of the Investigator.
    3. Localization-related, generalized or undetermined whether focal or generalized epileptic syndrome, according to ILAE classification.
    4. Presence of an EEG compatible with the clinical diagnosis of epilepsy.
    5. Subject having at least 1 seizure (any type) during the 3 weeks before V1.
    6. Subject taking at least 1 but no more than 3 concomitant AEDs. All AEDs need to be at a stable dose for at least 7 days prior to V1 and no additions or deletions of AEDs will be permitted. The dose of any concomitant AED will have to remain stable from V1 through the collection of PK samples. Vagal nerve stimulator stable for at least 2 weeks before V1, is allowed and will be counted as a concomitant AED. Benzodiazepine taken more than once a week (for any indication) will be considered as a concomitant AED.
    7. The subject is male or female and is between ≥1 month and <16 years of age at V1.
    8. Body weight at V1 is at least 3kg for infants.
    9. Female subjects without childbearing potential (premenarcheal or surgically sterile) are eligible.
    10. Female subjects with childbearing potential who are not sexually active are eligible. Subjects need to notify the Investigator if there is an anticipated change in their status.
    11. Adolescent female subjects with childbearing potential who are sexually active are eligible if they use a medically accepted contraceptive method. Oral or depot contraceptive treatment with at least ethinylestradiol 30μg per intake (or ethinylestradiol 50μg per intake if associated with any strong inducer [eg, carbamazepine, phenobarbital, primidone, phenytoin, oxcarbazepine, St. John’s Wort, rifampicin]),
    monogamous relationship with vasectomized partner, or double-barrier contraception are acceptable methods. The subject must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and undertake to inform the Investigator of any potential change in status.
    12. Females with childbearing potential must have a negative pregnancy test at V1.
    E.4Principal exclusion criteria
    1. Pregnant or nursing females.
    2. Concomitant use of LEV at V1. In addition, the use of LEV is prohibited for at least 4 weeks prior to V1.
    3. Epilepsy secondary to a progressive cerebral disease or tumor, or any other progressively neurodegenerative disease. Stable arteriovenous malformations, meningiomas or other
    benign tumors may be acceptable according to Investigator’s opinion.
    4. History of status epilepticus in the last month prior to V1 or during study Baseline.
    5. History or presence of pseudoseizures.
    6. Subject suffering only from febrile seizures.
    7. Subject on felbamate with less than 18 months continuous exposure. Subject who has taken felbamate for a combined duration of treatment and wash out of <18 months before V1.
    8. Subjects treated with vigabatrin who have visual field defects.
    9. Subject has an allergy to pyrrolidone derivatives, investigational product excipients or a history of multiple drug allergies.
    10. Subject has any clinically significant acute or chronic illness (as determined during the physical examination or from other information available to the Investigator: eg, bone marrow depression, chronic hepatic disease, severe renal impairment, psychiatric disorder).
    11. Subject has an underlying disease or is receiving a treatment that may interfere with the absorption, distribution, metabolism, and elimination of the study drug.
    12. Subject has any medical condition that might interfere with his/her study participation, ie, serious infection, scheduled elective surgery, etc.
    13. Subject has a history of suicide attempt or current suicidal ideation and/or behavior.
    14. Terminal illness.
    15. Subject has any clinically significant deviations from reference range values for laboratory parameters as determined by the Investigator.
    16. Clinically relevant ECG abnormality according to Investigator.
    17. Subject had major surgery within 6 months prior to V1.
    18. Subject received any investigational drug or device within the 30 days prior to V1. The use of AEDs marketed for adults but not approved for pediatric use is not considered to be “investigational” for the purposes of this study.
    19. Investigators and co-Investigators’ children may not be included as subjects in the study
    20. Subject has impaired hepatic function
    E.5 End points
    E.5.1Primary end point(s)
    The primary variables are the plasma concentrations of BRV and its metabolites ucb 42145 (acid), ucb 100406-1 (hydroxy), and ucb 107092-1 (hydroxyacid), and plasma concentrations of concomitant AEDs
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 7 (v3), Day 14 (v4), Day 21 (V5)
    E.5.2Secondary end point(s)
    SAFETY
    • Adverse events
    • Safety laboratory tests (hematology, biochemistry, including hepatic monitoring of ALT, AST, ALP, total bilirubin, and GGT, endocrinology, and urinalysis for subjects ≥4 years old)
    • ECGs
    • Vital signs (blood pressure, pulse rate, and body temperature)
    • Physical (Tanner scale) and neurological examination
    • Psychiatric and mental status
    • Body weight and height
    • Achenbach CBCL at Baseline for children 18 months and older (CBCL/1½-5 and CBCL/6-18) assessing behavior
    E.5.2.1Timepoint(s) of evaluation of this end point
    Some or all of the secondary endopoints are evaluated on: Day -7 (v1), Day 1 (v2), Day 7 (v3), Day 14 (v4), Day 21 (v5), Day 35 (v6), Day 49 (v7)
    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 No
    E.6.6Pharmacokinetic Yes
    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 No
    E.6.13.1Other scope of the trial description
    To explore direct medical resources use and cost parameters
    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) 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 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.8.2.4Number of treatment arms in the trial1
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Belgium
    Czech Republic
    Mexico
    Poland
    Spain
    Turkey
    United States
    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 patient last visit
    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 months2
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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: 100
    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: 30
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 40
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    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 Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 100
    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)
    Plans for treatment or care after the subject has ended his/her participation in the trial are described in the following sections of the protocol:
    5.1.1 Study duration per subject
    6.3 Subject Withdrawal Criteria
    8.5 Visit 5 (Day 21)/Early Discontinuation Visit
    8.6 Visit 6 (Day 35, End of Down-Titration Visit for subjects not entering the LTFU study)
    8.7 Visit 7 (Day 49, Safety Visit for subjects not entering the LTFU study)
    10.2.24 Termination of the 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 Decision2012-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-13
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