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    Summary
    EudraCT Number:2012-005054-30
    Sponsor's Protocol Code Number:MRZ60201_3070_1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-10
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-005054-30
    A.3Full title of the trial
    Prospective, multicenter, randomized, double-blind, parallel-group, dose-response study of three doses Xeomin® (incobotulinumtoxinA, NT 201) for the treatment of lower limb spasticity in children and adolescents (age 2 - 17 years) with cerebral palsy
    Estudio de respuesta a dosis, de grupos paralelos, doble ciego, aleatorizado, multicéntrico y prospectivo de tres dosis de Xeomin® (incobotulinumtoxina, NT 201) para el tratamiento de la espasticidad en extremidades inferiores en niños y adolescentes (2-17 años) con parálisis cerebral
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dose-response study of efficacy and safety of Botulinum toxin type A to treat spasticity of the leg(s) in cerebral palsy
    A.4.1Sponsor's protocol code numberMRZ60201_3070_1
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/042/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerz Pharmaceuticals GmbH
    B.1.3.4CountryGermany
    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 supportMerz Pharmaceuticals GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerz Pharmaceuticals GmbH
    B.5.2Functional name of contact pointNA
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountryGermany
    B.5.4Telephone numberNANANA
    B.5.5Fax numberNANANA
    B.5.6E-mailclinicaltrials@merz.de
    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 Xeomin
    D.2.1.1.2Name of the Marketing Authorisation holderMerz Pharmaceuticals GmbH
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameNT 201
    D.3.2Product code NT 201
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNn.a.
    D.3.9.2Current sponsor codeNT 101
    D.3.9.3Other descriptive nameCLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS
    D.3.9.4EV Substance CodeSUB26174
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Lower limb spasticity due to cerebral palsy
    Espasticidad de miembros inferiores debido a paralisis cerebral
    E.1.1.1Medical condition in easily understood language
    Lower limb spasticity due to cerebral palsy
    Espasticidad de miembros inferiores debido a paralisis cerebral
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10058977
    E.1.2Term Spastic paresis
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) are effective in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.
    El propósito de este estudio es determinar si las inyecciones intramusculares de la toxina botulinica tipo A en la(s) pierna(s) son efectivas en el tratamiento de niños/adolescentes (de edades entre los 2 y 17 años) con incremento de tensión/rigidez muscular incontrolable (espasticidad) debido a la paralisis cerebral
    E.2.2Secondary objectives of the trial
    Not applicable
    na
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Female or male subject of 2 to 17 years of age (inclusive).
    ? Uni- or bilateral cerebral palsy with clinical need for uni- or bilateral LL injections with BoNT for the treatment of spasticity.
    ? Ashworth Scale [AS] score ?2 in plantar flexors (at least unilaterally).
    ? Clinical need for a total dose of 16 U/kg BW NT 201 (maximum of 400 U) for the treatment of LL spasticity according to the clinical judgment of the investigator4.
    Individuo de sexo femenino o masculino de 2 a 17 años de edad (inclusive).
    ? Parálisis cerebral unilateral o bilateral con necesidad clínica de inyecciones unilaterales o bilaterales en las EI con BoNT para tratar la espasticidad.
    ? Puntuación en la escala de Ashworth [EA] ? 2 en los flexores plantares (al menos de forma unilateral).
    ? Necesidad clínica de una dosis total de 16 U/kg PCor de NT 201 (máximo de 400 U) para tratar la espasticidad de las EI según el criterio clínico del investigador.
    E.4Principal exclusion criteria
    1. Fixed contracture defined as severe restriction of the range of joint movement on passive stretch or predominant forms of muscle hypertonia other than spasticity (e.g., dystonia) in the target limb(s).
    2. Surgery on pes equinus on side(s) intended to be treated with BoNT injections in this study within 12 months prior to Screening Visit (V1), in the screening period or planned for the time of participation in this study.
    3. Hip flexion requiring BoNT injection.
    4. Limitation of hip abduction to less than 40° or pre-diagnosed migrational percentage greater than 30.
    1. Contractura fija, definida como limitación importante del rango de movimiento articular en un estiramiento pasivo o formas predominantes de hipertonía muscular que no sea espasticidad (p. ej., distonía) en las extremidades diana.
    2. Intervención quirúrgica en el pie equino en el lado que está previsto tratar con inyecciones de BoNT en este ensayo en los 12 meses anteriores a la visita de cribado (V1), durante el periodo de cribado o de administración prevista mientras se está participando en este ensayo.
    3. Flexión de cadera para la que se necesite una inyección de BoNT.
    4. Limitación de la abducción de cadera hasta menos de 40° o porcentaje migracional prediagnosticado superior a 30.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline (Day 1) in the AS score of plantar flexors (for subjects with bilateral pes equinus body side to be decided by investigator at screening and to be kept throughout the entire study) at Day 29 (Week 4) of the 1st injection cycle.

    Co-primary efficacy variable (to fulfil the PMC, for US regulatory authorities only):
    ? Investigator?s Global Impression of Change of Plantar Flexor Spasticity Scale [GICS-PF] (for subjects with bilateral treatment on same body side as chosen for the primary efficacy variable) at Day 29 (Week 4) of the 1st injection cycle.
    El cambio con respecto al momento de referencia (día 1) en la puntuación en la EA de los flexores plantares (en el caso de los individuos con pie equino bilateral, el investigador tendrá que elegir un lado del cuerpo en el cribado y tendrá que mantenerlo durante todo el ensayo) el día 29 (semana 4) del 1º ciclo de inyección.
    Variable de eficacia coprimaria (para cumplir el CPC, solo para autoridades oficiales de los Estados Unidos):
    ? Escala de impresión global de los cambios en la espasticidad de los flexores plantares [EIGC-FP] por parte del investigador (en individuos con tratamiento bilateral en el mismo lado del cuerpo que se hubiera elegido para valorar la variable de eficacia primaria) el día 29 (semana 4) del 1º ciclo de inyección.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 4 of 1st injection cycle
    Semana 4 del primer ciclo de inyección
    E.5.2Secondary end point(s)
    - For subjects with bilateral treatment: Change from baseline in the AS score of plantar flexors of the other treated body side at Day 29 (Week 4) of the 1st and 2nd injection cycle.
    - Change from baseline in the AS score of plantar flexors (for subjects with bilateral pes equinus body side to be decided by investigator at screening and to be kept throughout the entire study) at Day 29 (Week 4) of the 2nd injection cycle.
    - Changes from baseline in AS score of plantar flexors (for subjects with bilateral pes equinus body side to be decided by investigator at screening and to be kept throughout the entire study) at Day 57 (Week 8) and Day 85 (Week 12) of the 1st and of the 2nd injection cycle.
    - For subjects with unilateral treatment: Changes from baseline in AS score of knee flexors or thigh adductors at Day 29 (Week 4) of the 1st and of the 2nd injection cycle.
    - Changes from baseline in modified Tardieu Scale [MTS] of plantar flexors (for subjects with bilateral pes equinus body side to be decided by investigator at screening and to be kept throughout the entire study) at Day 29 (Week 4), Day 57 (Week 8), and Day 85 (Week 12) of the 1st and of the 2nd injection cycle.
    - Investigator?s, Child?s/Adolescent?s, and Parent?s/Caregiver?s Global Impression of Change Scale [GICS] at Day 29 (Week 4) of the 1st and 2nd injection cycle.
    - Investigator?s Global Impression of Change of Plantar Flexor Spasticity [GICS-PF] (for subjects with bilateral treatment on same body side as chosen for the primary efficacy variable) at Day 29 (Week 4) of the 1st and 2nd injection cycle.
    - Changes from baseline in Gross Motor Function Measure [GMFM]-66 score at the End of 1st Cycle Visit V6 and at the End of Study Visit V11.
    - Change in scores of pain intensity (from subjects) and pain frequency (from parent/caregiver) assessed with ?Questionnaire on Pain caused by Spasticity [QPS]? to all post baseline visits of the 1st and of the 2nd injection cycle.
    - Time to reinjection for each of the three dose groups for the 1st and 2nd injection cycle.
    Para individuos con tratamiento bilateral: Cambios con respecto al momento de referencia en la puntuación en la EA de los flexores plantares del otro lado del cuerpo tratado el día 29 (semana 4) del 1º y el 2º ciclo de inyección.
    ? El cambio con respecto al momento de referencia en la puntuación en la EA de los flexores plantares (en el caso de los individuos con pie equino bilateral, el investigador tendrá que elegir un lado del cuerpo en el cribado y tendrá que mantenerlo durante todo el ensayo) el día 29 (semana 4) del 2º ciclo de inyección.
    ? Los cambios con respecto al momento de referencia en la puntuación en la EA de los flexores plantares (en el caso de los individuos con pie equino bilateral, el investigador tendrá que elegir un lado del cuerpo en el cribado y tendrá que mantenerlo durante todo el ensayo) el día 57 (semana 8) y el día 85 (semana 12) del 1º y el 2º ciclo de inyección.
    Para individuos con tratamiento unilateral: Cambios con respecto al momento de referencia en la puntuación en la EA de los flexores de la rodilla o los aductores del muslo el día 29 (semana 4) del 1º y el 2º ciclo de inyección.
    Cambios con respecto al momento de referencia en la escala de Tardieu modificada [ETM] de los flexores plantares (en el caso de los individuos con pie equino bilateral, el investigador tendrá que elegir un lado del cuerpo en el cribado y tendrá que mantenerlo durante todo el ensayo) el día 29 (semana 4), el día 57 (semana 8) y el día 85 (semana 12) del 1º y el 2º ciclo de inyección.
    ? Escala de impresión global de los cambios [EIGC] del investigador, los niños o adolescentes y los padres o cuidadores el día 29 (semana 4) del 1º y el 2º ciclo de inyección.
    ? EIGC-FP del investigador (en individuos con tratamiento bilateral en el mismo lado del cuerpo que se hubiera elegido para valorar la variable de eficacia primaria) el día 29 (semana 4) del 1º y el 2º ciclo de inyección.
    ? Cambios con respecto al momento de referencia en la puntuación de la Gross Motor Function Measure [GMFM]-66 al final de la visita V6 de final del 1º ciclo y en la visita de final del ensayo V11.
    ? Cambios en las puntuaciones de la intensidad del dolor (obtenidas de los individuos) y la frecuencia del dolor (obtenidas de los padres o cuidadores) valorados con el ?Cuestionario sobre el dolor causado por la espasticidad [CDE]? en todas las visitas posteriores a la del momento de referencia del 1º y el 2º ciclo de inyección.
    Momento de una nueva inyección en cada uno de los tres grupos posológicos del 1º y el 2º ciclo de inyección.
    E.5.2.1Timepoint(s) of evaluation of this end point
    between week 4 and week 72 (for details see definition of endpoints)
    Entre la semana 4 y la semana 72 (para detalles ver la definicion de objetivos)
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) 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 Yes
    E.8.1.7.1Other trial design description
    dose-response study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Mismo IMP, EN 3 brazos de dosis diferentes
    same IMP, 3 different doses arms
    E.8.2.4Number of treatment arms in the trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Austria
    Czech Republic
    Estonia
    France
    Germany
    Israel
    Korea, Republic of
    Poland
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Turkey
    Ukraine
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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: 300
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 180
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 120
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    underage subjects and underage subjects with intellectual disability
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 300
    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)
    No specific post-study arrangements are made and no specific post-study care will be performed after this study, however subjects with duration of both injection cycles between 12 and 16 weeks may subsequently enroll into the open-label long-term study MRZ60201_3071_1 in which all subjects receive 4 injection treatments with active treatment. Recruitment in MRZ60201_3071_1 is competitive with newly recruited subjects, so enrollment can not be guaranteed.
    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 Decision2013-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-11
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