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    Summary
    EudraCT Number:2018-001639-35
    Sponsor's Protocol Code Number:M602011014
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2019-06-25
    Trial 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-001639-35
    A.3Full title of the trial
    Prospective, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of NT 201 in the treatment of lower limb spasticity caused by stroke or traumatic brain injury in adult subjects, followed by an open label extension with or without combined upper limb treatment
    Studio prospettico, multicentrico, randomizzato, in doppio cieco, controllato con placebo per studiare l'efficacia e la sicurezza di NT 201 nel trattamento della spasticità dell'arto inferiore causata da ictus o lesione cerebrale traumatica in soggetti adulti, seguito da un'estensione in aperto con o senza trattamento combinato dell'arto superiore
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to compare the efficacy and safety of NT 201 (botulinum toxin) with placebo for the treatment of lower limb spasticity caused by stroke or traumatic brain injury.
    Studio per comparare l'efficacia e la sicurezza di NT 201 (tossina botulinica) con placebo per il trattamento della della spasticità dell'arto inferiore causata da ictus o lesione cerebrale traumatica
    A.3.2Name or abbreviated title of the trial where available
    PATTERN (Multi-PAttern TreaTment of uppEr and loweR limb with iNcobotulinumtoxinA)
    PATTERN(Trattamento a schema multiplo dell’arto inferiore superior con tossina botulinica di tipo A)
    A.4.1Sponsor's protocol code numberM602011014
    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 Pharmaceutical 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 pointPublic Disclosure Manager
    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.5.4Telephone number+496915030
    B.5.5Fax number+49691503200
    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 AuthorisationGermany
    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 INNBotulinum-Toxin Type A
    D.3.9.1CAS number 93384-43-1
    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 number200
    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 Yes
    D.3.11.13.1Other medicinal product typeNeurotoxin
    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
    Diagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury
    Diagnosi di spasticitá all’arto inferiore con o senza spasticitá all’arto superiore della stessa parte del corpo causato da ictus o lesione cerebrale traumatica
    E.1.1.1Medical condition in easily understood language
    Lower limb or combined lower limb and upper limb spasticity due to stroke or traumatic brain injury
    Spasticitá all’arto inferiore o spasticitá combinata all’arto inferiore e superiore causata da ictus o lesione cerebrale traumatica
    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 20.0
    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
    Evaluation of the efficacy and safety of 400 U of NT 201 in the treatment of adult lower limb spasticity involving the ankle plantar flexors.
    Valutare l'efficacia e la sicurezza di 400 unità [U] di NT 201 nel trattamento della spasticità dell'arto inferiore negli adulti che coinvolge i flessori plantari della caviglia
    E.2.2Secondary objectives of the trial
    Evaluation of the long-term safety of NT 201 in the treatment of spasticity with total body doses up to 800 U.
    Valutare la sicurezza a lungo termine di NT 201 nel trattamento della spasticità con dosi corporee totali fino ad un massimo di 800 U
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main inclusion criteria
    • Female or male subject ≥ 18 years and ≤ 85 years at screening
    • Diagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury
    • Disabling ankle flexor spasticity presenting as pes equinus or pes equinovarus
    • Modified Ashworth Scale-Bohannon [MAS] score of 2 or 3 points in the ankle plantar flexor of the target lower limb (supine position, knee extended)
    • Minimum passive range of motion in ankle of the target lower limb (supine position, knee extended): 10°dorsiflexion and 20°plantarflexion
    • At least 4 months since last botulinum neurotoxin [BoNT] injection for treatment of spasticity or any other condition
    • For subjects receiving anticoagulation therapy, the investigator confirms and documents that the subject has an:
    o Activated partial thromboplastin time [aPTT] ≤ 80 seconds (subjects on dabigatran or other direct thrombin inhibitors) or
    o International normalized ratio [INR] value of ≤ 2.5 (subjects on coumarins or other anticoagulants monitored by INR)

    Main eligibility criteria for re-injection
    • According to the experience-based opinion of the investigator, the subject must have a clinical need for 400 U of NT 201 in the affected lower limb
    • Body weight at least 50 kg
    • Negative urine pregnancy test for women of childbearing potential
    • For subjects receiving anticoagulation therapy, the investigator confirms and documents that the subject has an:
    o aPTT ≤ 80 seconds (subjects on dabigatran or other direct thrombin inhibitors) or
    o INR value of ≤ 2.5 (subjects on coumarins or other anticoagulants monitored by INR)
    • No infection or inflammation in the area of the planned injection sites at the visits
    Principali criteri di inclusione
    •Soggetti di sesso femminile o maschile in età compresa tra ≥ 18 anni e ≤ 85 anni allo screening
    •Diagnosi di spasticità all'arto inferiore con o senza spasticità dell'arto superiore dello stesso lato del corpo causata da ictus o lesione cerebrale traumatica
    •Spasticità invalidante dei flessori della caviglia che si presenta come piede equino o piede equino-varo
    •Punteggio della scala di Ashworth modificata-Bohannon [MAS] di 2 o 3 punti nel flessore plantare della caviglia dell'arto inferiore target (posizione supina, ginocchio esteso)
    •Intervallo passivo minimo del movimento della caviglia dell'arto inferiore target (posizione supina, ginocchio esteso): 10° dorsiflessione e 20° di plantarflessione
    •Almeno 4 mesi dall'ultima iniezione di neurotossina botulinica [BoNT] per il trattamento della spasticità o di qualsiasi altra condizione
    •Per i soggetti che ricevono la terapia anticoagulante, lo sperimentatore conferma e documenta che il soggetto abbia:
    oTempo di tromboplastina parziale attivata [aPTT] ≤ 80 secondi (soggetti che assumono dabigatran o altri inibitori diretti della trombina) oppure
    oValore del Rapporto internazionale normalizzato [INR] di ≤ 2,5 (soggetti che assumono cumarine o altri anticoagulanti monitorati dall'INR)
    Principali criteri di eleggibilità per l'ulteriore iniezione
    •Secondo il parere dello sperimentatore, basato sull'esperienza, il soggetto deve avere l'esigenza clinica di 400 U di NT 201 nell'arto inferiore interessato
    •Peso corporeo di almeno 50 kg
    •Test di gravidanza sulle urine negativo per le donne in età fertile
    •Per i soggetti che ricevono la terapia anticoagulante, lo sperimentatore conferma e documenta che il soggetto abbia:
    o aPTT ≤ 80 secondi (soggetti che assumono dabigatran o altri inibitori diretti della trombina) oppure
    o valore INR di ≤ 2,5 (soggetti che assumono cumarine o altri anticoagulanti monitorati dall'INR)
    •Nessuna infezione o infiammazione, alle visite, nell'area delle sedi previste per l'iniezione
    E.4Principal exclusion criteria
    Main exclusion criteria
    • Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert Eaton syndrome, amyotrophic lateral sclerosis) or any other significant peripheral neuromuscular dysfunction which might interfere with the study
    • Bilateral lower limb paresis/paralysis/spasticity or tetraparesis/paralysis/spasticity
    • Body weight < 50 kg
    • Severe atrophy of the target limb muscles
    • Previous, ongoing or planned treatments of spasticity with intrathecal baclofen
    • Previous, ongoing, or planned treatments of spasticity in the target lower limb with any of the following procedures:
    o Surgical intervention
    o Alcohol or phenol block
    o Muscle afferent block
    • Physiotherapy or use of orthoses or splints at the target limb initiated less than 4 weeks before screening or expected to change during the double blind phase of the study
    • Current or planned treatment with parenterally administered drugs that interfere with neuromuscular transmission (e.g. intrathecal baclofen, tubocurarine type muscle relaxants used in anesthesia),, or local anesthetics in the treated region within 2 weeks prior to screening
    • Infection or inflammation at the injection sites
    • Subjects with presence or history of aspiration pneumonia, recurrent lower respiratory tract infections, or compromised respiratory function as per investigator's clinical judgment
    • Pregnancy (as verified by a positive pregnancy test) or breast feeding
    Principali criteri di esclusione
    •Disordini generalizzati dell'attività muscolare (per es. miastenia grave, sindrome di Lambert Eaton, sclerosi laterale amiotrofica) o qualsiasi altra disfunzione neuromuscolare periferica significativa che potrebbe interferire con lo studio
    •Paresi/paralisi/spasticità bilaterale degli arti inferiori o tetraparesi/paralisi/spasticità
    •Peso corporeo < 50 kg
    •Grave atrofia dei muscoli dell'arto target
    •Trattamenti precedenti, in corso o pianificati della spasticità con baclofen intratecale
    •Trattamenti precedenti, in corso o pianificati della spasticità all'arto inferiore target con una qualsiasi delle seguenti procedure:
    o Intervento chirurgico
    o Blocco con alcool o fenolo
    o Blocco degli afferenti muscolari
    •Fisioterapia o impiego di ortesi o tutori nell'arto target iniziati meno di 4 settimane prima dello screening o modifica prevista dei medesimi durante la fase in doppio cieco dello studio
    •Trattamento attuale o pianificato con farmaci somministrati per via parenterale che interferiscono con la trasmissione neuromuscolare (per es. baclofen intratecale, rilassanti muscolari di tipo tubocurarina usati in anestesia) o anestetici locali nella regione trattata entro 2 settimane prima dello screening
    •Infezione o infiammazione nelle sedi dell'iniezione
    •Soggetti con presenza o storia di polmonite da aspirazione, infezioni ricorrenti delle vie respiratorie inferiori o funzione respiratoria compromessa secondo il giudizio clinico dello sperimentatore
    •Gravidanza (come verificata da un test di gravidanza positivo) o allattamento
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary efficacy variables:
    • Change from baseline in derived Modified Ashworth Scale-Bohannon (MAS) ankle score (knee extended)
    • Global Impression of Change Scale (GICS) assessed by physician

    Primary safety variable:
    Occurrence of treatment emergent adverse events [TEAEs] in Main Period
    Variabili co-primarie di efficacia:
    • Variazione del basale nel punteggio MAS derivato per la caviglia (ginocchio esteso)
    • GICS [Global Impression of Change Scale -Impressione globale di cambiamento] valutato da un medico

    Variabile di sicurezza primaria:
    • Insorgenza di eventi avversi emergenti dal trattamento [treatment emergent adverse events, TEAE] nel Periodo principale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoints of evaluation of Co-primary efficacy variables:
    • Modified Ashworth Scale-Bohannon (MAS) ankle score at Weeks 4 to 6
    • Global Impression of Change Scale (GICS) assessed at Week 4 to 6

    Timepoint of evaluation of the primary safety variable:
    • During Main Period
    Tempo di valutazione delle variabili co-primarie di efficacia:
    • punteggio MAS derivato per la caviglia (ginocchio esteso) a 4 e a 6 settimane
    • GICS [Global Impression of Change Scale - Impressione globale di cambiamento] a 4 e a 6 settimane

    Tempo di valutazione della Variabile di sicurezza primaria:
    • Durante il periodo principale
    E.5.2Secondary end point(s)
    Key secondary efficacy variable:
    • Change from Study Baseline in Goal Attainment Scale [GAS]

    Other secondary efficacy variables:
    • Global Impression of Change Scale (GICS) assessed by subject
    • Global Impression of Change Scale (GICS) assessed by caregiver
    Variabili secondarie chiave di efficacia:
    • Variazione dal basale dello studio nella Scala di raggiungimento dell'obiettivo [Goal Attainment Scale, GAS]

    Altre Variabili di efficacia secondarie:
    • GICS [Global Impression of Change Scale - Impressione globale di cambiamento] valuato dal soggetto
    • GICS [Global Impression of Change Scale - Impressione globale di cambiamento] valuato dal caregiver

    E.5.2.1Timepoint(s) of evaluation of this end point
    • Goal Attainment Scale [GAS] at Week 6 (V4)
    • GICS assessed by subject at Week 4 (V3) to Week 6 (V4).
    • GICS assessed by caregiver at Week 4 (V3) to Week 6 (V4).
    • GAS alla Settimana 6 (V4)
    • GICS valutato dal soggetto dalla Settimana 4 (V3) alla Settimana 6 (V4).
    • GICS valutato dal caregiver dalla Settimana 4 (V3) alla Settimana 6 (V4).
    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
    Disegno adattivo a 2fasi con rivalutazione interinale delle dimensioni del campione dopo 360soggetti
    Two-stage adaptive design with interim sample size reassessment after 360 subjects (Treatment/OLEX)
    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.8.2.4Number of treatment arms in the trial2
    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 EEA59
    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
    Australia
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Italy
    Norway
    Poland
    Portugal
    Russian Federation
    Spain
    Switzerland
    United Kingdom
    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
    The End of the entire study, is defined as the date of attendance of the last subject of the final visit of the OLEX period (V17 for subjects with five cycles or V20 with six cycles).
    Ultima visita ultimo paziente
    La fine dello studio e’ definita come la data in cui l’ultimo soggetto completa la visita finale del periodo di estensione in aperto (v17 per i soggetti con 5 cicli o V20 con 6 cicli)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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.1.2.1Number of subjects for this age range: 540
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 374
    F.4.2.2In the whole clinical trial 600
    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)
    None
    After study discontinuation, the subjects will be treated by their physician according to their medical condition and standard treatments in the country concerned.
    Nessuno
    Dopo l’interruzione, il soggetto verra’ trattato dal proprio medico in accordo alle Sue condizioni mediche e ai trattamenti strandard nel paese interessato
    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 Decision2019-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-23
    P. End of Trial
    P.End of Trial StatusRestarted
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