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    Summary
    EudraCT Number:2012-005496-14
    Sponsor's Protocol Code Number:MRZ60201_3072_1
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-02-22
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2012-005496-14
    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 upper limb spasticity alone or combined upper and lower limb spasticity in children and adolescents (age 2 - 17 years) with cerebral palsy.
    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 arm(s) or of arm(s) and leg(s) in cerebral palsy
    A.3.2Name or abbreviated title of the trial where available
    XARA – IncobotulinumtoXinA in aRm treatment in Cerebral PAlsy
    A.4.1Sponsor's protocol code numberMRZ60201_3072_1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02002884
    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 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 pointN.N.
    B.5.3 Address:
    B.5.3.1Street AddressEckenheimer Landstrasse 100
    B.5.3.2Town/ cityFrankfurt/Main
    B.5.3.3Post code60318
    B.5.3.4CountryGermany
    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 AuthorisationPoland
    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 FROM 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Upper limb spasticity or combined upper and lower limb spasticity in children and adolescents
    (age 2 - 17 years) with cerebral palsy
    E.1.1.1Medical condition in easily understood language
    Upper limb and combined upper and lower limb spasticity due to cerebral palsy
    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 19.1
    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 one or both arms alone or in combination with injections into one or both legs are effective and safe in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.
    E.2.2Secondary objectives of the trial
    Not applicable
    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 CP with clinical need for injections with NT 201 for the treatment of upper limb spasticity at least unilaterally.
    - Ashworth Scale (AS) score in the main clinical target patterns in this study: a.Flexed elbow: AS≥2 in elbow flexors (at least unilaterally). And/or b.Flexed Wrist: AS≥2 in wrist flexors (at least unilaterally).
    - Clinical need according to the judgment of the investigator in one out of five treatment combinations.
    - AS score must be ≥2 for each target pattern chosen for injection at the Baseline Injection Visit V2.
    E.4Principal exclusion criteria
    Pre-treated (non-naïve) subjects must not have received BoNT treatment within the last 14 weeks prior to the Screening Visit (V1) in any indication.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome Measures:
    - Change from baseline in Ashworth Scale (AS) in the primary clinical target pattern, i.e. elbow flexors or wrist flexors at Day 29 (Week 4).
    Primary clinical target pattern is defined by the investigator.
    Co-primary outcome measure:
    - Investigator's Global Impression of Change Scale (GICS) at Day 29 (Week 4).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 29 (Week 4) of 1st injection cycle of main period.
    E.5.2Secondary end point(s)
    Secondary Outcome Measures:
    - Change from baseline in Ashworth Scale (AS) score of the other treated main clinical target pattern (i.e. of elbow flexors or wrist flexors, if treated) at Day 29 (Week 4).
    - Change from baseline in AS score of treated clinical target pattern clenched fist (in combination with flexed wrist) at Day 29 (Week 4).
    - Change from baseline in AS score for each treated clinical pattern (e.g., flexed elbow, flexed wrist, clenched fist, etc.) of the upper limb at all other post baseline visits of the main period (baseline up to week 14).
    - Change from baseline in scores of pain intensity (from subjects) and pain frequency (from parent/caregiver) assessed with Questionnaire on Pain caused by Spasticity at all post baseline visits of the main period (baseline up to week 14).
    - Child's/Adolescent's (if applicable) and Parent's/Caregiver's Global Impression of Change Scale at Day 29 (Week 4).
    - Occurrence of treatment emergent adverse events [TEAEs] overall and per treatment cycle.
    - Occurrence of TEAEs of Special Interest [TEAESIs] overall and per treatment cycle.
    - Occurrence of serious TEAEs [TESAEs] overall and per treatment cycle.
    - Occurrence of TEAEs related to treatment as assessed by the investigator overall and per treatment cycle.
    - Occurrence of TEAEs by worst intensity overall and per treatment cycle.
    - Occurrence of TEAEs by worst causal relationship overall and per treatment cycle.
    - Occurrence of TEAEs by final outcome overall and per treatment cycle.
    - Occurrence of TEAEs leading to discontinuation overall and per treatment cycle.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 29 (Week 4) of 1st injection cycle of main period or all post baseline visits of main period, respectively. Safety endpoints up to week 56.
    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 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
    same IMP, 3 different doses
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Argentina
    Korea, Republic of
    Mexico
    Poland
    Russian Federation
    Ukraine
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    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: 344
    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: 210
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 134
    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 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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 344
    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)
    After study discontinuation, the subjects will be treated by their physician according to their medical condition and standard treatments in the country concerned.
    Subjects who discontinue prematurely may receive treatment at the discretion of the investigator. The investigator and/or the subject's physician are free to apply any approved antispastic treatment, physiotherapy, orthotic management, and any other rehabilitation treatment.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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