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    Summary
    EudraCT Number:2018-003231-30
    Sponsor's Protocol Code Number:Linitox
    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:2018-09-17
    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 number2018-003231-30
    A.3Full title of the trial
    EFFECTIVENESS OF THE REPEATED INFILTRATIONS OF BOTULINUM TOXIN A IN THE GAIT AND QUALITY OF LIFE IN ADULTS WITH SPASTIC PARAPARESIA SECONDARY TO MULTIPLE SCLEROSIS
    EFECTIVIDAD DE LAS INFILTRACIONES REPETIDAS DE TOXINA BOTULÍNICA TIPO A EN LA MARCHA Y CALIDAD DE VIDA EN ADULTOS CON PARAPARESIA ESPÁSTICA SECUNDARIA A ESCLEROSIS MÚLTIPLE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFECTIVENESS OF REPEATED INJECTIONS OF BOTULINUM TOXIN IN THE GAIT AND QUALITY OF LIFE OF ADULT PATIENTS WITH WEAKNESS AND MUSCLE RIGIDITY DUE TO MULTIPLE ESCLEROSIS
    EFICACIA DE INYECCIONES REPETIDAS DE TOXINA BOTULÍNICA EN LA MARCHA Y CALIDAD DE VIDA DE PACIENTES ADULTOS CON DEBILIDAD Y RIGIDEZ MUSCULAR DEBIDA A ESCLÉROSIS MÚLTIPLE
    A.3.2Name or abbreviated title of the trial where available
    BOTULINUM TOXIN IN PATIENTS WITH SPASTIC PARAPARESIA ASSOCIATED WITH ESCLEROSIS MULTIPLE
    TOXINA BOTULÍNICA EN PACIENTES CON PARAPARESIA ESPÁSTICA ASOCIADA A ESCLÉROSIS MÚLTIPLE
    A.4.1Sponsor's protocol code numberLinitox
    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 SponsorAránzazu Vázquez Doce
    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 supportIPSEN
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAránzazu Vázquez Doce
    B.5.2Functional name of contact pointAránzazu Vázquez Doce
    B.5.3 Address:
    B.5.3.1Street AddressDiego de León, 62
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28006
    B.5.3.4CountrySpain
    B.5.4Telephone number0034915202367
    B.5.6E-mailvazquezdoce@hotmail.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 Dysport
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN PHARMA, S.A.
    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.3.4Pharmaceutical 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 codeDysport
    D.3.9.3Other descriptive nameBOTULINUM TOXIN TYPE A
    D.3.9.4EV Substance CodeSUB13117MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number250 to 1000
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple sclerosis
    Esclérosis múltiple
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis
    Esclérosis múltiple
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10063400
    E.1.2Term Secondary progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10063401
    E.1.2Term Primary progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effectiveness of repeated TXB infiltrations on gait in patients with Multiple Sclerosis who presented limb spasticity less than 4 weeks after infiltration and its maintenance over time at 12 months, using objective results obtained by the clinician (6MWT ) and reported by the patient (MSWS-12).
    Evaluar la efectividad de infiltraciones repetidas de TXB en la marcha, en pacientes con Esclerosis Múltiple que presentan espasticidad de miembros inferiores a las 4 semanas de la infiltración y su mantenimiento en el tiempo a los 12 meses, mediante resultados objetivos obtenidos por el clínico (6MWT) y reportados por el paciente (MSWS-12) .
    E.2.2Secondary objectives of the trial
    - Evaluation of spasticity (Modified Ashworth Spasticity scale - MAS scale).
    - Evaluation of disability (EDSS scale).
    - Evaluation of the quality of life after the use of botulinum toxin type A (MSQoL-54).
    - Assessment of medium and long-term objectives (GAS scale).
    - Evaluation of tolerance and side effects.
    - Evaluación del grado de espasticidad mediante la escala de espasticidad de Ashworth modificada (escala MAS).
    - Evaluación de la discapacidad (escala EDSS ).
    - Evaluación la calidad de vida tras el uso de toxina botulínica tipo A (MSQoL-54).
    - Valoración de los objetivos a medio y largo plazo (escala GAS).
    - Evaluación de tolerancia y efectos secundarios.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Acceptance and signature of informed consent.
    - Age between 18 and 80 years old, both included.
    - Patients with relapsing remitting multiple sclerosis (RRMS), progressive secondary (SP) and primary progressive (PP), with spasticity resistant to usual treatment, either because of the severity of the spasticity or because of intolerance to side effects.
    - Outpatients with spastic paraparesis that causes gait deficiency.
    - Patients with an EDSS score between 2 and 6, both included.
    - Patients with segmental involvement in MAS >1 in two or more muscle groups in the lower extremities.
    - Absence of cognitive disability. Score less than 5 on the SPMSQ scale of Pfeiffer.
    - Possibility of carrying out the treatment (method of administration, scheduled visits) and scales correctly.
    - Women of childbearing potential should use an effective contraceptive method (hormonal contraceptives, intrauterine device, condom) or refrain from having sex in order not to get pregnant. A woman is considered to be fertile after menarche and to become postmenopausal, unless she has undergone a permanent sterilization procedure (hysterectomy, salpingectomy, bilateral oophorectomy). A postmenopausal state is defined as absence of menstruation for 12 months without an alternative medical cause.
    - Aceptación y firma del consentimiento informado.
    - Edad entre 18 y 80 años, ambos incluidos.
    - Pacientes con esclerosis múltiple remitente recurrente (EMRR), secundaria progresiva (SP) y primaria progresiva (PP), con espasticidad resistente a tratamiento habitual, ya sea por la severidad de la espasticidad o por la intolerancia a los efectos secundarios.
    - Pacientes ambulatorios con paraparesia espástica que causa deficiencia en la marcha.
    - Pacientes con una puntuación EDSS entre 2 y 6, ambos incluidos.
    - Pacientes con afectación segmental en MAS >1 en dos o más grupos musculares en extremidades inferiores.
    - Ausencia de discapacidad cognitiva. Puntación menor de 5 en la escala SPMSQ de Pfeiffer.
    - Posibilidad de realizar el tratamiento (forma de administración, visitas programadas) y las escalas correctamente.
    - Las mujeres en edad fértil deben utilizar un método anticonceptivo eficaz (anticonceptivos hormonales, dispositivo intrauterino, preservativo) o abstenerse de mantener relaciones sexuales con el fin de no quedarse embarazada. Se considera que una mujer es fértil después de la menarquia y hasta convertirse en posmenopáusica, a menos que se haya sometido a un procedimiento de esterilización permanente (histerectomía, salpingectomía, ooforectomía bilateral). Un estado posmenopáusico se define como ausencia de menstruación durante 12 meses sin una causa medica alternativa.
    E.4Principal exclusion criteria
    - Psychiatric illness that hinders participation in the trial.
    - Comorbidity that threatens the patient's life in the short term (severe liver disease, cardiovascular disease, etc.).
    - Osteoarticular disorder that prevents physical activity.
    - Pregnancy or lactation.
    - Lack of primary or secondary response to any type of TXB for the treatment of MS previously detected.
    - Sensitivity to TXB or to any excipient.
    - Any medical condition that, in the opinion of the investigator, may compromise compliance with the objectives and / or procedures of this protocol or preclude the administration of TXB.
    - Changes in the treatment regimen of any drug that directly or indirectly interferes with neuromuscular function within 4 weeks before the start of the study treatment.
    - Enfermedad psiquiátrica que dificulte la participación en el ensayo.
    - Comorbilidad que amenace la vida del paciente a corto plazo (enfermedad hepática severa, enfermedad cardiovascular, etc.).
    - Desorden osteoarticular que impida la actividad física.
    - Embarazo o lactancia.
    - Falta de respuesta primaria o secundaria a cualquier tipo de TXB para el tratamiento de EM detectada previamente.
    - Sensibilidad a TXB o a cualquier excipiente.
    - Cualquier condición médica que, en opinión del investigador, pueda comprometer el cumplimiento de los objetivos y/o procedimientos de este protocolo o imposibilitar la administración de TXB.
    - Modificaciones en la pauta de tratamiento de cualquier fármaco que interfiera directa o indirectamente con la función neuromuscular en las 4 semanas antes del inicio del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - Change from baseline observed in the maximum distance that a patient can walk in 6 minutes (6MWT) at 4 weeks after each infiltration.
    - Changes from baseline in the score obtained in the MSWS-12 scale, at 4 weeks after each infiltration.
    - Cambio observado en la distancia máxima que puede recorrer un paciente en 6 minutos (6MWT) a las 4 semanas tras cada infiltración en relación a la puntuación basal .
    - Cambios en la puntuación obtenida en la escala MSWS-12, a las 4 semanas tras cada infiltración en relación a la puntuación basal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The values in these scales will be measured before the patient receives the treatment and 4 weeks after each injection. Each patient will undergo 3-4 treatment cycles of 12-16 weeks each.
    Los valores en dichas escalas serán medidos antes de que el paciente reciba el tratamiento y 4 semanas después de cada inyección. Cada paciente será sometido a 3-4 ciclos de tratamiento de duración de 12-16 semanas cada uno de ellos.
    E.5.2Secondary end point(s)
    - Change observed in the total score of the EDSS scale before and after the application of the treatment.
    - Observed change in the quality of life of patients before and after treatment, evaluated through the MSQoL-54 questionnaire.
    - Evaluation of the achievement of the treatment goal through the GAS scale.
    - Incidence of serious and not serious adverse reactions.
    - Incidence of serious and non-serious adverse events.
    - Tolerance to treatment.
    - Discontinuation due to adverse reactions.
    - Cambio observado en la puntuación total de la escala EDSS antes y después de la aplicación del tratamiento.
    - Cambio observado en la calidad de vida de los pacientes antes y después del tratamiento, evaluada a través del cuestionario MSQoL-54.
    - Evaluar si se ha alcanzado el objetivo del tratamiento a través de la escala GAS.
    - Incidencia de reacciones adversas graves y no graves.
    - Incidencia de acontecimientos adversos graves y no graves.
    - Tolerancia al tratamiento.
    - Discontinuación debido a reacciones adversas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The values in these scales will be measured before the patient receives the treatment and 4 weeks after each injection. Each patient will undergo 3-4 treatment cycles of 12-16 weeks each.
    Los valores en dichas escalas serán medidos antes de que el paciente reciba el tratamiento y 4 semanas después de cada inyección. Cada paciente será sometido a 3-4 ciclos de tratamiento de duración de 12-16 semanas cada uno de ellos.
    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 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 Yes
    E.8.1.7.1Other trial design description
    Ensayo clínico prospectivo de un solo brazo de bajo nivel de intervención.
    Prospective, single-arm, low-level intervention trial.
    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 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
    February 2021
    Febrero 2021
    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 months30
    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: 74
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state84
    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
    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 Decision2018-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-15
    P. End of Trial
    P.End of Trial StatusOngoing
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