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    Summary
    EudraCT Number:2010-021448-17
    Sponsor's Protocol Code Number:CBGG492A2212
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-02-21
    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 number2010-021448-17
    A.3Full title of the trial
    A multicenter, open-label, follow-up study to evaluate the long-term safety and tolerability of BGG492 TID as adjunctive therapy in patients with partial onset seizures completing double-blind, placebo-controlled study CBGG492A2207 or CBGG492A2211.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness and safety of BGG492 as add-on treatment in patients with partial onset seizures
    A.4.1Sponsor's protocol code numberCBGG492A2212
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01147003
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma GmbH
    B.5.2Functional name of contact pointMedizinischer Infoservice
    B.5.3 Address:
    B.5.3.1Street AddressRoonstr. 25
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90429
    B.5.3.4CountryGermany
    B.5.4Telephone number004901802232300
    B.5.5Fax number0049091127312160
    B.5.6E-mailinfoservice.novartis@novartis.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 nameBGG492
    D.3.2Product code BGG492
    D.3.4Pharmaceutical form Capsule, hard
    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 INNBGG492
    D.3.9.1CAS number 912574-69-7
    D.3.9.2Current sponsor codeBGG492
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Epilepsy Partial onset seizures
    E.1.1.1Medical condition in easily understood language
    Partial onset seizures
    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 13.1
    E.1.2Level PT
    E.1.2Classification code 10061334
    E.1.2Term Partial 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
    The primary objective is to evaluate the long-term safety and tolerability
    of BGG492 capsules TID at individualized doses, including 50 mg, 100 mg, 150 mg TID, in patients suffering from partial onset seizures.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are defined below.
    • To evaluate the maintenance of efficacy over time as assessed by the
    change in partial seizure frequency from the original Baseline Period (28
    days) in the double-blind study CBGG492A2207, to the Open-label
    Extension Maintenance Phase;
    • To evaluate the maintenance of efficacy over time as assessed by the
    change in responder rate and numbers of patients becoming seizure free
    from the Baseline Period in study CBGG492A2207 to the Open-label
    Extension Maintenance Phase;
    • To evaluate long-term efficacy and safety by summarizing the number
    and percentage of patients who discontinue due to unsatisfactory
    therapeutic effect and all other reasons.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have completed the 10-week Double-blind Treatment Evaluation Phase plus one week of dose-tapering (Visit 9, Day 78) in study CBGG492A2207, have cooperated with the study procedures and have not experienced persistent tolerability issues;
    2. Patients who wish to continue BGG492 treatment and from whom the investigator believes a reasonable benefit from the long-term
    administration of BGG492 may be expected;
    3. Male and female outpatients age 18 to 66 years (inclusive)
    4. Weight of ≥ 45 Kg (99 lb);
    5. Are currently treated with a stable dose of one or a maximum of three licensed AEDs and are known to take their medication(s) as directed.
    5.1 Allowed AEDs: Carbamazepine, Eslicarbazepine, Oxcarbazepine, Phenytoin, Valproate, Lacosamide, Lamotrigine, Levetiracetam, Clobazam, Topiramate, Zonisamide, Gabapentin, Pregabalin, Phenobarbital and Primidone;
    5.2 Vagal nerve stimulation (VNS) will be counted as one AED;
    5.3 Stable benzodiazepine treatment administered for e.g. epilepsy, anxiety, or sleep disorders will be counted as one AED.
    6. Are reliable and willing to make themselves available for the study period and are able to record seizures and report adverse events themselves or have a caregiver who can record and report the events;
    7. Have provided written informed consent before any extension assessment is performed.
    E.4Principal exclusion criteria
    1. History of status epilepticus or seizure clusters (where individual seizures cannot be counted according to the judgement of the investigator) occurring during Study CBGG492A2207 or in the period between the end of study
    CBGG492A2207 and the start of study CBGG492A2212 for patients
    experiencing a treatment gap;
    2. Have been treated with:
    2.1 Felbamate, unless treatment has been continuous for ≥ 2 years;
    2.2 Vigabatrin during 26 weeks prior to the first dose of open-label
    medication in the extension study;
    2.3 Monoamine oxidase (MAO) inhibitors, tricyclic-antidepressants and
    narcotic analgesics such as e.g. morphine, oxycodone, fentanyl, codeine within 8 weeks prior to the first dose of open-label medication in the extension study;
    2.4 L-Dopa formulations;
    2.5 Used concomitant medication that are potential inhibitors of OATP
    transporters e.g. cyclosporine, rifampin, fluvastatine, fexofenadine 8 weeks prior to the first dose of open-label medication in the extension study.
    3. No physical examination changes suggestive of progressive
    neurological changes (e.g. Alzheimer's disease, Parkinson's Disease,
    Multiple Sclerosis) during Study CBGG492A2207;
    4. History of hypersensitivity to the study drug or to drugs of similar
    chemical classes (e.g. sulfonamides);
    5. Have had multiple drug allergies or one ore more severe drug reactions to an AED, including dermatological reactions, (e.g. Stevens-Johnson syndrome, hematological, or organ toxicity reactions); a rash would not be exclusionary;
    6. Use of other investigational drugs apart from BGG492 either at the time of enrollment in the extension study or within 5 half-lives prior to enrollment in the extension study if the experimental medication was taken during the potential treatment gap between the studies;
    7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a negative hCG laboratory test (≥ 5 mIU/mL) and a negative urine test prior to administering the first dose of open-label study medication;
    8. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means:
    Effective contraception methods include one of the following:
    • Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository),
    • other more effective forms such as oral, injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or total abstinence, or male/female sterilization.

    For a full list please see protocol section 4.2
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of long-term safety and tolerability of BGG492 capsules
    during the maintenance period in patients suffering from partial onset
    seizures
    E.5.1.1Timepoint(s) of evaluation of this end point
    29 weeks
    E.5.2Secondary end point(s)
    - Evaluation of efficacy over time by the change in partial seizure
    frequency original baseline period in the double-blind study
    CBGG492A2207 to the open-label extension maintenance phase.
    - Responder rate: Evaluation of maintenance of efficacy by the change in responder rate and numbers of patients becoming seizure free from
    baseline period to the open-label extension maintenance phase.
    - Seizure counts: Evaluation of maintenance of efficacy and safety as
    assessed in percent change of seizure frequency of BGG492 capsules
    from baseline period to the open-label extension maintenance phase.
    - Evaluation of long-term efficacy and safety by summarizing the number and percentage of patients who discontinue due to unsatisfactory therapeutic response effect and for all other reasons.
    E.5.2.1Timepoint(s) of evaluation of this end point
    29 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 Yes
    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.8.3 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 EEA15
    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
    Germany
    Hungary
    Korea, Republic of
    Poland
    Slovakia
    United States
    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
    LVLS
    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 months0
    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 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 No
    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) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 No
    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 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 40
    F.4.2.2In the whole clinical trial 62
    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 Decision2011-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-07-04
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