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    Summary
    EudraCT Number:2022-004127-40
    Sponsor's Protocol Code Number:ESPSEVMOLIN2022
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-16
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2022-004127-40
    A.3Full title of the trial
    Clinical trial on the effectiveness and safety of botulinum toxin type A (incobotulinumtoxin) in doses adapted to the individual needs of patients with severe spasticity
    Ensayo clinico sobre la efectividad y seguridad de la toxina botulínica tipo A (incobotulinumtoxina) en dosis adaptadas a las necesidades individuales de los pacientes con cuadros de espasticidad severa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    effectiveness and safety of botulinum toxin type A in doses adapted for patients with severe spasticity
    efectividad y seguridad de la toxina botulínica tipo A en dosis adaptadas para pacientes con cuadros de espasticidad severa
    A.4.1Sponsor's protocol code numberESPSEVMOLIN2022
    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 SponsorDra. Nuria Gutierrez Dubón
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDra. Nuria Gutierrez Dubón
    B.5.2Functional name of contact pointDra. Nuria Gutierrez Dubón
    B.5.3 Address:
    B.5.3.1Street AddressPlaça Poligono 38, 1
    B.5.3.2Town/ citySerra (Valencia)
    B.5.3.3Post code46118
    B.5.3.4CountrySpain
    B.5.6E-mailnuriagutierrezdubon@gmail.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 Yes
    D.2.1.1.1Trade name Xeomin
    D.2.1.1.2Name of the Marketing Authorisation holderMerz Pharma España S.L.
    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 nameIncobotulinumtoxinA
    D.3.2Product code IncobotulinumtoxinA
    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.3.9.3Other descriptive nameBotulinum toxin type A
    D.3.9.4EV Substance CodeSUB13117MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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
    brain damage oriented spasticity
    Espasticidad orientada al daño cerebral
    E.1.1.1Medical condition in easily understood language
    spasticity
    Espasticidad
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy and safety of the administration of IncobotulinumtoxinA at individualized doses, selected based on the individual needs of patients (spasticity patterns) with severe spasticity and involvement of the upper and lower limbs.
    Determinar la eficacia y seguridad de la administración de IncobotulinumtoxinA a dosis individualizadas, seleccionadas en función de las necesidades individuales de los pacientes (patrones de espasticidad) con espasticidad severa y afectación de miembros superiores e inferiores.
    E.2.2Secondary objectives of the trial
    Not described
    No descritos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients older than 18 years
    - with a diagnosis of severe multifocal spasticity of the upper and lower limbs due to acquired brain damage.
    - Who need treatment with IncobotulinumtoxinA at a dose equal to or greater than 800U
    - That they agree to participate in the study and sign the informed consent
    - With pain assessment data (VAS scale), muscle tone (Asworth scale), and Barthel scale during the follow-up evaluation.
    - No contraindications for treatment with botulinum toxin.
    - Pacientes mayores de 18 años
    -Con diagnóstico de espasticidad multifocal severa de miembros superiores e inferiores por daño cerebral adquirido.
    -Que necesitan tratamiento con IncobotulinumtoxinA a dosis igual o mayores de 800U
    - Que acepten participar en el estudio y firmen el consentimiento informado
    -Con datos de valoración del dolor (escala EVA), tono muscular (escala Asworth), y escala de Barthel durante la evaluación de seguimiento.
    - Sin contraindicaciones para el tratamiento con toxina botulínica.
    E.4Principal exclusion criteria
    -Patients with severe systemic diseases and active infection
    -Pregnant patients or under lactating period.
    -Pacientes con enfermedades sistémicas graves e infección activa
    -Pacientes embarazadas o en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Asworth scale at 6 weeks of treatment
    Escala de Asworth a las 6 semanas del tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks
    6 semanas
    E.5.2Secondary end point(s)
    -Pain: Variation on the VAS scale (0-10) at 6 and 12 weeks of treatment.
    -Effect on the Asworth scale at 12 weeks from drug infiltration.
    -Barthel scale at 6 and 12 weeks after injection
    -Satisfaction with treatment
    -Assess the safety and tolerability of the treatment.
    -Dolor: Variación en la escala EVA (0-10) a las 6 y 12 semanas del tratamiento.
    -Efecto sobre la escala de Asworth a las 12 semanas desde la infiltración del medicamento.
    -Escala de Barthel a las 6 y 12 semanas tras la inyección
    -Satisfacción con el tratamiento
    -Valorar la seguridad y tolerabilidad del tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 and 12 weeks.
    6 y 12 semanas
    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 No
    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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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.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
    Ninguno
    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 Decision2023-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-13
    P. End of Trial
    P.End of Trial StatusOngoing
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