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    Summary
    EudraCT Number:2008-000144-14
    Sponsor's Protocol Code Number:N01276
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-05-09
    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 number2008-000144-14
    A.3Full title of the trial
    An international, double-blind, randomized, multi-center, parallel group, historical-control conversion to monotherapy study to evaluate the efficacy and safety of brivaracetam in subjects (≥ 16 to 75 years old) with partial onset seizures with or without secondary generalization.
    A.4.1Sponsor's protocol code numberN01276
    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 SponsorUCB Inc
    B.1.3.4CountryUnited States
    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 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 namebrivaracetam
    D.3.2Product code ucb 34714
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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(α1S, 4R)-α-ethyl-2-oxo-4-propyl- 1-pyrrolidineacetamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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.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 Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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(α1S, 4R)-α-ethyl-2-oxo-4-propyl- 1-pyrrolidineacetamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Partial onset seizures with or without secondary generalization.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10015037
    E.1.2Term Epilepsy
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of BRV in the conversion to monotherapy at the doses of 50 and 100 mg/day (administered in two equal doses per day) in subjects with partial onset seizures when compared to a historical pseudo-placebo control group.

    The primary objective of this study is based on the White Paper on Alternative Monotherapy Design in the Treatment of Epilepsy.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of BRV in subjects undergoing conversion to monotherapy for POS.
    • To explore direct medical resources use and indirect cost parameters.
    • To explore the impact of BRV on different Patient Reported Outcomes (PRO): The Quality of Life Inventory in Epilepsy (QOLIE-31-P), the Hospital Anxiety and Depression Scale (HADS), the EQ-5D, and a Patient-reported Global Evaluation Scale (GES).
    • To explore the impact of BRV on the Investigator’s GES.
    • To obtain a description of the patient’s self-reported health status.
    • To explore the population pharmacokinetics of BRV in monotherapy.
    • To collect blood samples for genotyping of SV2-and epilepsy-related genes (for a pooled analysis at the program level).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • An IEC/IRB approved written informed consent signed and dated by the subject or by parent(s) or legal representative. The consent form or a specific assent form, where required, will be signed and dated by minors.
    • Subjects from 16 to 75 years, both inclusive. Subjects under 18 years may only be included where permitted legally and ethically accepted. In Germany, only subjects 18 years and older may be included.
    • Subjects with a body weight ≥ 45 kg.
    • Female subjects without childbearing potential (pre-menarcheal, post-menopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method. Oral or depot contraceptive treatment with at least 30 μg [or 50 μg ethinylestradiol per intake if associated with carbamazepine (or other strong enzyme inducers e.g. oxcarbazepine)] must be used in conjunction with a barrier method. 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. Sexual inactivity might be accepted on a case-by-case basis.
    • Subject/legally acceptable representative considered as reliable and capable of adhering to the protocol (e.g. able to understand and complete diaries), visit schedule or medication intake according to the judgment of the Investigator.
    • Well-characterized partial onset seizures according to the ILAE classification (1981) or focal epilepsy or epileptic syndrome according to the ILAE classification (1989).
    • Presence of an EEG compatible with the clinical diagnosis of focal epilepsy in the last 5 years. If an EEG has not been performed within the last 5 years, a Baseline EEG must be performed before Visit 3.
    • Presence of a brain CT Scan or MRI performed within the last 2 years. If a CT Scan or MRI has not been performed within the last 2 years, a Baseline exam must be performed before Visit 3. (In Germany, if no previous exam is available, only a MRI will be performed).
    • Subjects with a history of inadequately controlled partial onset seizures that may be classified as simple or complex whether or not secondarily generalized (type I seizures according to the ILAE classification, 1981).
    • Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period. (NOTE: Aura is a subjective ictal phenomenon, usually visual, visceral or auditory, that in a given subject may precede an observable seizure. When it occurs by itself it constitutes a simple partial sensory seizure. Auras followed by an observable seizure should only be counted as one event and receive the ILAE code of the observable seizure while stand-alone auras should be counted as a seizure and receive the corresponding ILAE code (1981)).
    • Subjects must be on a stable dose of at least 1 but no more than 2 concomitant AEDs for at least 4 weeks before Baseline (Visit 1) and expected to remain on a stable dose until the tapering period commences.
    • If a second AED is taken, its dose must be ≤ 50% of the minimum recommended maintenance dose approved in the US for at least 4 weeks before Baseline (Visit 1).
    E.4Principal exclusion criteria
    • Seizure type IA simple partial non-motor as only seizure type.
    • History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted, during the 6 months preceding Visit 1 or during Baseline.
    • History or presence of status epilepticus during the 1 year preceding Visit 1 or during Baseline.
    • History or presence of pseudo-seizures.
    • Subjects on felbamate with less than 18 months continuous exposure before Visit 1. Subjects having been on felbamate are eligible if the combined duration of treatment and wash-out is ≥ 18 months.
    • Subjects currently on vigabatrin. Subjects having been on vigabatrin if no visual fields examination report available including standard static (Humphrey or Octopus) or kinetic perimetry (Goldman) or if results of these examinations are abnormal.
    • Subjects who have received treatment with phenobarbital or primidone within 3 months prior to Visit 1 and subjects who have received treatment with benzodiazepines within 1 month prior to Visit 1. Subjects with VNS are excluded unless their device has been documented to be inactivated for at least 28 days prior to Visit 1.
    • Subjects taking any drug with possible relevant CNS effects except if stable from at least 1 month before Visit 1 and expected to be kept stable during the study.
    • Subjects taking any drug that may significantly influence the metabolism of BRV (CYP2C or CYP3A potent inducers/inhibitors) except if the dose has been kept stable at least one month before Visit 1, and is expected to be kept stable during the study.
    • History of cerebrovascular accident (CVA), including transient ischemic attack (TIA), in the last 6 months.
    • Subjects suffering from severe cardiovascular disease or peripheral vascular disease.
    • Presence of any sign (clinical or imaging techniques) suggesting rapidly progressing (i.e. not expected to stay stable during trial participation) brain disorder or brain tumor. Stable arteriovenous malformations, meningiomas or other benign tumors may be acceptable.
    • Any clinical conditions (e.g. bone marrow depression, chronic hepatic disease and/or severe renal impairment) which impair reliable participation in the trial or necessitate the use of medication not allowed by protocol.
    • Presence of a terminal illness.
    • Presence of a serious infection.
    • Subjects with history of severe adverse hematologic reaction to any drug.
    • Subjects suffering from severe disturbance of haemostasis. Impaired hepatic function: ALT/SGPT, AST/SGOT, alkaline phosphatase, GT values of more than three times the upper limit of the reference range. A result of GT exceeding 3 times the upper limit can only be accepted if attributable to hepatic enzyme induction caused by concomitant antiepileptic treatment and other hepatic enzymes are below 3 times the upper limit of the reference range.
    • Subjects having clinically significant deviations from reference range values for laboratory parameters: creatinine clearance calculated < 50 mL/min, platelets < 100,000/μL, or neutrophil cells < 1,800/μL).
    • Clinically significant ECG abnormalities according to the Investigator.
    • History of suicide attempt.
    • Ongoing psychiatric disease other than mild controlled disorder.
    • Subjects who are institutionalized due to judicial reasons. In Germany, no mentally impaired subjects will be included, whether institutionalized or not.
    • Known allergic reaction or intolerance to pyrrolidone derivatives and/or investigational product excipients (BRV excipients are as follows: Croscarmellose sodium, lactose, beta cyclodextrin, magnesium stearate, Opadry TM {hydroxypropylmethylcellulose, macrogel, PEG, sodium saccharinate, talc and titanium dioxide}. PBO excipients are: Lactose, magnesium stearate, microcristalline cellulose, aerosil and opadry TM).
    • Known multiple drug allergies or severe drug allergy.
    • Pregnant or lactating women.
    • Known alcohol or drug addiction or abuse within the last 2 years.
    • Subjects taking part in another clinical/pharmacological trial in the month preceding Visit 1.
    • Investigators, co-investigators, their spouses or children or any trial collaborators.
    • Subjects previously treated with BRV.
    • Subjects previously screened within this trial. If the Investigator has any medically valid reason to doubt the eligibility of a subject, the subject should not be included into the trial. If however, the Investigator has any other kind of doubts concerning the eligibility, he/she should consult UCB Study Physician or representative for clarification.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Variables:
    The primary efficacy end point is the cumulative exit rate at 112 days after the beginning of the tapering phase (at Visit 4) of the Baseline AED(s).

    Safety Variables:
    • Adverse events reporting.
    • Laboratory tests (blood chemistry, hematology, urinalysis, pregnancy testing, thyroid profile analysis).
    • Electrocardiogram (ECG).
    • Physical and neurological examinations.
    • Vital signs including orthostatic measurements.
    • Body weight.

    Pharmacokinetic Variables:
    • BRV (parent compound only) plasma levels.
    • Concomitant AED (and/or relevant metabolites) plasma levels.
    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 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.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    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 visit of the last subject undergoing the trial.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 155
    F.4.2.2In the whole clinical trial 223
    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 medical care after subject has ended his/her participation in the trial are detailed in the study protocol in:
    • Section 8.1 Type/Design - sub-sections "Evaluation/Early Discontinuation Visit" and "Reconversion and Follow-up Period".
    • Section 11.2.9 "Early Discontinuation Visit".
    • Section 11.2.10 "Visit 9 (Re-conversion and Follow-up Period)".
    • Section 11.2.11 "Visit 10 / Final Visit".
    • Section 11.2.12 " Unscheduled Study Visit or Phone Call".
    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 Decision2008-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-05-17
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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