Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-004293-10
    Sponsor's Protocol Code Number:REH-TOX-2013-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-04-01
    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 number2013-004293-10
    A.3Full title of the trial
    Efficacy of treatment by iontophoresis of botulinum toxin type A free from complexing proteins for stump hyperhidrosis
    Eficacia del tratamiento mediante iontoforesis de toxina botulínica tipo A sin proteínas complejantes para la hiperhidrosis del muñón de amputación
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of treatment by iontophoresis of botulinum toxin type A free from complexing proteins for the excessive sweating of the stump
    Eficacia del tratamiento mediante iontoforesis de toxina botulínica tipo A sin proteínas complejantes para la excesiva sudoración del muñón de amputación
    A.3.2Name or abbreviated title of the trial where available
    HYPERHIDROSIS
    HIPERHIDROSIS
    A.4.1Sponsor's protocol code numberREH-TOX-2013-01
    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 SponsorHospital Universitari de Tarragona Joan XXIII
    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 supportMerz Pharma España S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitari de Tarragona Joan XXIII
    B.5.2Functional name of contact pointIria Bascuas Rodríguez
    B.5.3 Address:
    B.5.3.1Street AddressDr Mallafrè Guasch 4
    B.5.3.2Town/ cityTarragona
    B.5.3.3Post code43005
    B.5.3.4CountrySpain
    B.5.4Telephone number34977295801
    B.5.5Fax number34977224011
    B.5.6E-mailirivenir@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 nameBotulinum neurotoxin type A free from complexing proteins
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIontophoresis
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClostridium Botulinum Neurotoxin Type A (150 kD), free of complexing proteins
    D.3.9.1CAS number 93384-43-1
    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 IU international unit(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number400
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIontophoresis
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Stump hyperhidrosis in lower limb amputees
    Hiperhidrosis del muñón de amputación de extremidades inferiores
    E.1.1.1Medical condition in easily understood language
    Excessive sweating of the stump in lower limb amputees
    Sudoración excesiva del muñón de amputación de extremidades inferiores
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10020642
    E.1.2Term Hyperhidrosis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Check the effectiveness of botulinum toxin type A free of complexing proteins used by iontophoresis to decrease sweating of lower limb stump.
    Comprobar la eficacia de la toxina botulínica Tipo A sin proteínas complejantes utilizada mediante iontoforesis para reducir la sudoración del muñón de amputación de la extremidad inferior.
    E.2.2Secondary objectives of the trial
    - Assess comfort / tolerability/adverse effects of the technique
    - Determine the duration of effect
    - Assess if there are significant changes in patients? quality of life
    - Assess if significant changes occur in six minutes walking test
    - Assess if there is any impact on the level of pain on the stump and the phantom limb
    - Valorar confort/tolerabilidad de la técnica/efectos secundarios/ reacciones adversas
    - Determinar duración del efecto
    - Valorar si hay cambios significativos en la calidad de vida de los pacientes
    - Valorar si produce cambios significativos a nivel funcional con test 6 minutos marcha
    - Valorar si hay algún impacto a nivel de dolor del muñón de amputación y de miembro fantasma
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Lower limb amputation at any level.
    - Evolution of time since the amputation: 6 months or more.
    - Prosthesis wearers.
    - Activity level: K2-K4.
    - Excessive sweating of the stump that produces alteration in the use / fit of the prosthesis.
    - Approval and signing of informed consent.
    - Age >18.
    - Amputación extremidad inferior a cualquier nivel.
    - Tiempo evolutivo desde amputación: 6 meses o más.
    - Portadores de prótesis.
    - Nivel de actividad: K2-K4.
    - Sudoración excesiva del muñón que produzca alteración en el uso/ajuste de la prótesis.
    - Autorización y firma de consentimiento informado.
    - Edad >18 años.
    E.4Principal exclusion criteria
    - Having another type of treatment for excessive sweating of the stump.
    - Existence of contraindications to the use of botulinum toxin: hypersensitivity to the molecule, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, peripheral neuromuscular disorders.
    - Having a pacemaker.
    - Cutaneous impairment in the stump: infection or loss of skin integrity.
    - Pregnancy or lactation
    - Estar realizando otro tipo de tratamiento para la hipersudoración del muñón.
    - Existencia de contraindicaciones para el uso de toxina botulínica: hipersensibilidad a la molécula, miastenia gravis, síndrome de Eaton-Lambert, esclerosis lateral amiotrófica, trastornos neuromusculares periféricos.
    - Ser portador de marcapasos.
    - Alteración cutánea en el muñón amputación: infección o pérdida de integridad de la piel.
    - Embarazo o lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Questionnaire:
    - How much sweat do you have during the day? (VAS 0-10)
    - How much does sweat interfere in the placement of the prosthesis? (VAS 0-10)
    - How long can you walk without losing adhesion of the prosthesis? (timed)
    - How many times a day do you have to remove the prosthesis to dry the stump and the socket?
    - How much pain do you have in the amputation stump? (VAS 0-10)
    - How much phantom limb pain do you have? (VAS 0-10)
    Cuestionario referido al muñón de amputación:
    - ¿Cuánto sudor tiene al día? (EVA 0-10)
    - ¿Cuánto interfiere el sudor en la colocación de la prótesis? (EVA 0-10)
    - ¿Cuánto tiempo puede caminar sin perder la adherencia de la prótesis? (tiempo min)
    - ¿Cuántas veces al día se tiene que quitar la prótesis para secar el muñón y el encaje?
    - ¿Cuánto dolor tiene en el muñón de amputación? (EVA 0-10)
    - ¿Cuánto dolor de miembro fantasma tiene? (EVA 0-10)
    E.5.1.1Timepoint(s) of evaluation of this end point
    One week before and 15 days after placebo intervention,15 days, 1.5 months, 2.5 months and 3.5 months after real intervention.
    Una semana antes y 15 días después de la intervención placebo; y 15 días, 1.5 meses, 2.5 meses y 3.5 meses después de la intervención real.
    E.5.2Secondary end point(s)
    - Pain / Discomfort during the procedure (VAS 0-10)
    - Scale of quality of life: SF-36.
    - 6 minute walking test
    - Complications / adverse effects.
    - Dolor/Molestias durante la intervención (EVA 0-10)
    - Escala de calidad de vida: SF-36.
    - Test 6 minutos marcha.
    - Complicaciones/Efectos adversos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    One week before and 15 days after placebo intervention,15 days, 1.5 months, 2.5 months and 3.5 months after real intervention.
    Una semana antes y 15 días después de la intervención placebo; y 15 días, 1.5 meses, 2.5 meses y 3.5 meses después de la intervención real.
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Usamos los mismos pacientes como controles con la intervención placebo inicial
    We use the same patients as their own control by performing initial placebo intervention.
    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 trial1
    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
    última visita del último paciente
    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 months5
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state18
    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 Decision2014-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 18 08:11:40 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA