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    Summary
    EudraCT Number:2004-001856-35
    Sponsor's Protocol Code Number:N01114
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-04
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2004-001856-35
    A.3Full title of the trial
    A multicenter, double-blind, randomized, placebo-controlled, 3 parallel groups, dose-ranging trial evaluating the efficacy and safety of ucb 34714 used as adjunctive treatment at doses of 50 and 150 mg/day in b.i.d. administration (oral capsules of 25 mg) for a maximum of 12 weeks in subjects from 16 to 65 years with refractory epilepsy suffering from partial onset seizures whether or not secondarily generalized
    A.3.2Name or abbreviated title of the trial where available
    ucb 34714 dose-ranging
    A.4.1Sponsor's protocol code numberN01114
    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 S.A. Pharma Sector
    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 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 Information not present in EudraCT
    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.3.2Product code ucb 34714
    D.3.4Pharmaceutical form Capsule*
    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 INNnot yet available
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboCapsule*
    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
    Epilepsy - Refractory Partial Onset Seizure wheter or not secondarily generalized.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level LLT
    E.1.2Classification code 10061334
    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 efficacy of ucb 34714 at the doses of 50 and 150 mg/day in b.i.d. administration in reducing seizure frequency in subjects with focal epilepsy not fully controlled despite treatment with 1 or 2 concomitant AED(s).
    E.2.2Secondary objectives of the trial
    - To evaluate the dose/clinical response relationship and narrow down the dose range of clinical interest.
    - To explore tolerability of ucb 34714 in the same population.
    - To collect data on seizure-free days and seizure-free subjects.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    •An IEC 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.
    •Well-characterized focal epilepsy or epileptic syndrome according to the ILAE classification, which was supported by adequate diagnostic documentation (EEG and MRI/CT scan).
    •Subjects with a history of partial onset seizures whether or not secondarily generalized.
    •Subjects having at least 4 partial onset seizures whether or not secondarily generalized during the 4-week Baseline Period and at least 2 partial onset seizures whether or not secondarily generalized per month during the 3 months preceding V1.
    •Subjects being uncontrolled while treated by 1 or 2 concomitant AED(s). Vagal Nerve Stimulation (VNS) is allowed and will not be counted as a concomitant AED.
    •Concomitant AED(s) being stable from at least 1 month before Visit 1 and during the whole trial period.
    •Male/female subjects from 16 to 65 years, both inclusive. Subjects under 18 years may only be included where legally permitted and ethically accepted.
    •Female subjects without childbearing potential (2 years post-menopausal, 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 if associated with carbamazepine (CBZ) ethinylestradiol per intake 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.
    •Subject/legally acceptable representative considered as reliable and capable of adhering to the protocol (e.g. able to understand and complete diaries and questionnaires), visit schedule or medication intake according to the judgment of the Investigator.
    E.4Principal exclusion criteria
    •Seizure type IA non-motor as only seizure type.
    •History or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time, i.e. < 20 minutes, with or without function regained between 2 ictal events during the last 5 years before V1.
    •History or presence of status epilepticus during the last five years before V1.
    •History or presence of known pseudo-seizures.
    •Subjects on felbamate or having been on felbamate.
    •Subjects currently on vigabatrine. Subjects having been on vigabatrine if no visual fields examination report available including standard static (Humphrey or Octopus) or cinetic perimetry (Goldman).
    •Subject taking any drug with possible CNS effects effects except if stable from at least 1 month before Visit 1 and during the whole trial period. Benzodiazepine (BZD)
    taken more than once a week (for any indication) will be considered as a
    concomitant AED.
    •Subjects taking any drug that may significantly influence the metabolism of ucb 34714 (CYP2C or CYP3A potent inducers/inhibitors) except if the dose has been kept stable at least 1 month before V1, and will be kept stable during the entire trial duration.
    •History of cerebrovascular accident (CVA), including transient ischemic attack (TIA), after which the subject’s condition had not stabilized and recurrence could not be excluded.
    •Subjects suffering from severe cardiovascular 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 with prior approval by UCB.
    •Any clinical conditions (e.g. bone marrow depression, chronic hepatic disease and/or severe renal impairment) which may contraindicate the use of ucb 34714, impair reliable participation in the trial or necessitate the use of medication not allowed by protocol.
    •Presence of 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.
    •Subjects suffering from severe hyperuricaemia.
    •Presence of unstable hyperthyroidism.
    •Impaired hepatic function: ALAT/SGPT, ASAT/SGOT, alkaline phosphatase, GT value of more than three times the upper limit of the reference range.
    •Subject having clinically significant deviations from reference range values for laboratory parameters: creatinine clearance < 50 ml/min, platelets < 100,000/l, or neutrophil cells < 1,800/l).
    •Clinically significant ECG abnormalities according to Investigator.
    •History of suicide attempt, current suicidal ideation or other serious psychiatric disorders [i.e. bipolar disorder, severe depression (with hallucinations and illusions), psychosis] requiring or having required hospitalization or medication within the previous five years.
    •Known allergic reaction or intolerance to pyrrolidine derivatives and/or investigational product excipients.
    •Known multiple drug allergies or severe drug allergy.
    •Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method.
    •Subjects with a body weight less than 45 kg.
    •Known alcohol or drug addiction or abuse within the last two years.
    •Subject institutionalized under judicial decision.
    •Subject taking part in another clinical/pharmacological trial in the three months preceding enrolment (V1).
    •Investigators, co-investigators, their spouses or children or any trial collaborators may not be included as subjects in the trial.
    •Subjects having been blood donator during the previous 3 months before V1 or planning to be blood donator during the trial.
    •Subject previously allocated to a trial treatment 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 CRP or representative for clarification.
    E.5 End points
    E.5.1Primary end point(s)
    The intention-to-treat population (ITT) will consist of all randomized subjects who took at least one dose of trial medication.

    The per-protocol population (PP) is a subset of the intention-to-treat population, consisting of those subjects who had no major protocol deviations affecting the primary efficacy variable, as confirmed during a pre-analysis meeting prior to unblinding of the data.

    The analyses will be based on the ITT population unless stated otherwise.

    The periods considered in the definition of efficacy and safety variables are the following:
    •Baseline Period (V1 until V2).
    •Up-titration period (V2 to V5).
    •Treatment Period (V2 until the earlier of V8 and Early Discontinuation Visit).
    •Maintenance Period (V5 until the earlier of V8 and Early Discontinuation Visit).
    •Conversion Period (V8 until V11).
    •Down-titration Period (V8 or Early Discontinuation Visit until V11).
    •Post-treatment Period (V11 until V12).

    Efficacy variables
    Seizure frequency per week will be derived from the seizure count information recorded on the DRC and is defined as the number of seizures standardized to a seven day period. It is computed as the number of seizures recorded over the period, divided by the total number of days in that period, multiplied by 7.

    The primary efficacy variable is the partial onset seizure frequency per week (type I) over the Maintenance Period.

    The secondary efficacy variables are as follows:
    •Seizure frequency per week for all seizures (types I+II+III) over the Maintenance Period.
    •Reductions and percentage reductions from Baseline in seizure frequency per week for partial onset seizures (type I) and for all seizures (types I+II+III) over the Maintenance Period.
    •Responder rate in partial onset seizures (type I) over the Maintenance Period. A responder is defined as a subject with a ≥ 50% reduction in seizure frequency per week from the Baseline Period to the Maintenance Period.
    •Response to treatment in partial onset seizures (type I) over the Maintenance Period. The percentage reduction from Baseline in partial seizure frequency per week over the Maintenance Period will be grouped in 4 categories: < -25%, -25% to < 25%, 25% to < 75%, 75% to 100%.
    •Percentage of seizure-free subjects over the Maintenance Period.
    •Percentage of seizure-free days over Baseline and Maintenance Periods.

    Exploratory variables
    •Patient’s Global Evaluation Scale at V8 or Early Discontinuation Visit.
    •Investigator’s global Evaluation Scale at V8 or Early Discontinuation Visit.
    •Health-Related Quality of Life (QOLIE-31-P) at V2 and at V8 or Early Discontinuation Visit.
    •Hospital Anxiety and Depression Scale (HADS) at V2 and at V8 or Early Discontinuation Visit.
    •Medical resources used over the Baseline Period and over the Evaluation Period, including health care provider consultations not foreseen by the protocol, concurrent medical procedures, concomitant medications, hospitalizations and length of stay.

    Safety variables
    Safety assessments will be made using adverse events, laboratory tests (including blood and urine), electrocardiogram (ECG), physical and neurological examinations, vital signs and body weight.

    The number of subjects who follow the fallback option, the time to fallback and the reason of fallback will also be investigated in order to give the most accurate information on the data used for the primary efficacy analysis.

    Pharmacokinetic variables
    •ucb 34714 (parent compound only): plasma levels in all subjects, at each specified visit under trial drug
    •Concomitant AED(s) (and/or relevant metabolites): plasma levels in all subjects at baseline and at each specified visit under trial drug.
    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 Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) 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 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 trial is defined as the date of the database lock as, at that time, interactions between the Sponsor and the Investigator(s) with possible impact on subjects data have ended.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.2Adults (18-64 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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
    Subject/legally acceptable representative considered as reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the Investigator.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 192
    F.4.2.2In the whole clinical trial 192
    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)
    A long-term follow-up program (trial N01125) will allow subjects to continue on ucb 34714 until European approval has been obtained or until UCB decides to stop.
    This trial will start when the final results of the 6 and 9-month toxicology studies in rats and monkeys will be available and notified where required. In case of non-availability of these result, subjects reaching the end of N01114 should be withdrawn from trial drug.
    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 Decision2004-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-01-17
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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