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    Summary
    EudraCT Number:2022-001522-30
    Sponsor's Protocol Code Number:RIMOFATSCI-2
    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:2022-10-04
    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 number2022-001522-30
    A.3Full title of the trial
    Effects of a CB1 receptor reverse antagonist/agonist (Rimonabant) on wandering ability in patients with incomplete spinal cord injuries
    Efectos de un antagonista/agonista inverso del receptor CB1 (Rimonabant) sobre la capacidad para la deambulación en lesionados medulares incompletos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of a CB1 receptor reverse antagonist/agonist (Rimonabant) on wandering ability in patients with incomplete spinal cord injuries
    Efectos de un antagonista/agonista inverso del receptor CB1 (Rimonabant) sobre la capacidad para la deambulación en lesionados medulares incompletos
    A.4.1Sponsor's protocol code numberRIMOFATSCI-2
    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 SponsorFundación Hospital Nacional de Parapléjicos
    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 supportInstituto Salud Carlos III - FEDER
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Hospital Nacional de Parapléjicos
    B.5.2Functional name of contact pointAntonio Oliveiro
    B.5.3 Address:
    B.5.3.1Street AddressFinca de la Peraleda, s/n
    B.5.3.2Town/ cityToledo
    B.5.3.3Post code45071
    B.5.3.4CountrySpain
    B.5.4Telephone number0034925247761
    B.5.6E-mailugihnp@externas.sescam.jccm.es
    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 No
    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 nameRIMONABANT
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRIMONABANT
    D.3.9.1CAS number 168273-06-1
    D.3.9.4EV Substance CodeSUB21719
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Possibility of improving wandering in patients. The effects of Rimonabant on other functional measures will be assessed and it will be confirmed that it is a safe treatment in the study population.
    Poibilidad de mejora de la deambulación en pacientes. Se valorarán los efectos de Rimonabant en otras medidas funcionales y se confirmará que es un tratamiento seguro en la población estudiada.
    E.1.1.1Medical condition in easily understood language
    Possibility of improving wandering in patients. The effects of Rimonabant on other functional measures will be assessed and it will be confirmed that it is a safe treatment in the study population.
    Poibilidad de mejora de la deambulación en pacientes. Se valorarán los efectos de Rimonabant en otras medidas funcionales y se confirmará que es un tratamiento seguro en la población estudiada.
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    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 demonstrate that Rimonabant can improve wandering in spinal cord injured patients. The main efficacy variable will be the distance in meters that can be covered in six minutes
    Demostrar que Rimonabant puede mejorar la deambulación en pacientes lesionados medulares. Como variable principal de eficacia se recogerá la distancia en metros que se puede recorrer en seis minutos
    E.2.2Secondary objectives of the trial
    To confirm that Rimonabant is safe in a specific population such as the population with chronic phase spinal cord injury. The following will be collected as security variables:
    1) AEs;
    2) biochemical, blood pressure, heart rate, and ECG changes;
    3) pain;
    4) spasticity and spasms;
    5) mood.
    Obtain information on the effects of Rimonabant in a specific population such as the population with chronic phase spinal cord injury. The effects that we are going to evaluate (in addition to the effects evaluated as main objectives) are:
    1) walking speed;
    2) perceived fatigue after exertion;
    3) the general fatigue of the subject;
    4) muscle strength;
    5) the patient's general assessment of functionality and quality of life.
    Confirmar que Rimonabant es seguro en una población específica como la población con lesión medular en fase crónica. Se recogerán como variables de seguridad:
    1) los AA;
    2) las modificaciones bioquímicas, de tensión arterial, frecuencia cardiaca y de ECG;
    3) el dolor;
    4) la espasticidad y los espasmos;
    5) el estado de ánimo.
    Obtener información sobre efectos del Rimonabant en una población específica como la población con lesión medular en fase crónica. Los efectos que vamos a valorar (además de los efectos evaluados como objetivos principales) son:
    1) la velocidad de marcha;
    2) la fatigabilidad percibida después de un esfuerzo;
    3) la fatiga general el sujeto;
    4) la fuerza muscular;
    5) la valoración general del paciente sobre funcionalidad y calidad de vida.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Between 18 and 75 years of age
    2. Incomplete traumatic or non-traumatic, non-progressive spinal cord injury: paraplegia or tetraplegia (ASIA C or D). In case of traumatic spinal cord injury due to attempted suicide with resolved psychiatric pathology, a psychiatric report is necessary to rule out a high risk of suicide
    3. Spinal cord injury: level of injury between C4 and L1
    4. More than 12 months from the date of injury (chronic phase)
    5. Ability to walk with or without assistance of at least 5 meters
    6. Psychiatric assessment ruling out high risk of suicide
    7. Ability to provide informed consent.
    1. Entre 18 y 75 años de edad
    2. Lesión medular incompleta traumática o non traumática, non progresiva : paraplejia o tetraplejia (ASIA C o D).
    3. Lesión medular: nivel de lesión entre C4 y L1
    4. Más de 12 meses desde la fecha de la lesión (fase crónica)
    5. Capacidad de marcha con o sin auxilios de un mínimo de 5 metros
    6. Valoración psiquiátrica que descarte elevado riesgo de suicidio.
    7. Capacidad de proporcionar el consentimiento informado
    E.4Principal exclusion criteria
    1. Under 18 years of age or over 75 years of age
    2. high risk of suicide
    3. Spinal cord injury with ASIA A, B, or E
    4. Spinal cord injury: level of injury above C4 or below L1
    5. Acute phase of rehabilitation: less than one year from date of injury
    6. Walking ability with or without aids < 5 meters or no walking ability
    7. Treatment with anticoagulants
    8. Pregnancy or lactation
    9. Men or Women of childbearing age, who cannot guarantee the use of contraceptive methods considered highly effective, with a failure rate of less than 1% per year when used consistently and correctly.
    A woman of childbearing age is considered to be any woman physiologically capable of becoming pregnant, from menarche to becoming postmenopausal, unless she is permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menstruation for 12 months without an alternative medical cause. A high level of follicle-stimulating hormone (FSH) in the postmenopausal range can be used to confirm a postmenopausal status in women not using hormonal contraceptives or hormone replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.

    The methods considered acceptable are:
    - Combined hormonal contraception (containing estrogen and progestogen) associated with the inhibition of ovulation, either oral, intravaginal or transdermal.
    - Progestin-only hormonal contraception associated with ovulation inhibition (oral, injectable, or implantable)
    - Intrauterine device (IUD)
    - Intrauterine hormone releasing system (IUS)
    - Bilateral tubal occlusion
    - Vasectomized partner: provided that it is the only sexual partner of the trial participant and that the vasectomized partner has received a medical evaluation of the success of the surgery.
    - Sexual abstinence: Abstain from sexual intercourse during the entire period of treatment and follow-up of the study.
    10. Hypothyroidism, bone, liver or kidney severe disease
    11. Inability to go to the Hospital
    12. Inability to provide informed consent
    1. Menores de 18 años de edad o mayor de 75 años de edad
    2. Lesión medular traumática por intento autolítico con patología psiquiátrica no resuelta (informe psiquiátrico que NO descarte elevado riesgo de suicidio)
    3. Lesión medular con ASIA A, B, ó E
    4. Lesión medular: nivel de lesión por encima de C4 o por debajo de L1
    5. Fase aguda de la rehabilitación: menos de un año desde la fecha de la lesión
    6. Capacidad de marcha con o sin auxilios < de 5 metros o sin capacidad de marcha
    7. Tratamiento con anticoagulantes
    8. Embarazo o lactancia
    9. Hombres o Mujeres en edad fértil, que no puedan garantizar la utilización de métodos anticonceptivos considerados altamente eficaces, con una tasa de fracaso de menos del 1% por año cuando se usa de manera consistente y correcta.
    Se considera mujer en edad fértil toda aquella mujer fisiológicamente capaz de quedarse embarazada, desde la menarquia hasta convertirse en posmenopáusica, a menos que sea permanente estéril. Los métodos de esterilización permanentes incluyen histerectomía, salpingectomía bilateral y ooforectomía bilateral. Un estado posmenopáusico se define como ausencia de menstruación durante 12 meses sin una causa médica alternativa. Un nivel alto de hormona estimulante del folículo (FSH) en el rango posmenopáusico puede ser utilizado para confirmar un estado posmenopáusico en mujeres que no usan anticonceptivos hormonales o terapia de reemplazo hormonal. Sin embargo, en ausencia de 12 meses de amenorrea, una sola medición de FSH es insuficiente.

    Los métodos considerados aceptables son:

    - Anticoncepción hormonal combinada (que contiene estrógeno y progestágeno) asociada a la inhibición de la ovulación, ya sea oral, intravaginal o transdérmica.
    - Anticoncepción hormonal de progestágeno solo asociada con la inhibición de la ovulación (oral, inyectable o implantable)
    - Dispositivo intrauterino (DIU)
    - Sistema de liberación hormonal intrauterino (SIU)
    - Oclusión tubárica bilateral
    - Pareja vasectomizada: siempre que sea la única pareja sexual de la participante en el ensayo y que la pareja vasectomizada haya recibido una evaluación médica del éxito de la cirugía.
    - Abstinencia sexual: Abstenerse de tener relaciones sexuales durante todo el periodo de tratamiento y seguimiento del estudio.
    10. Hipotiroidismo, Enfermedad ósea, hepática o renal severa
    11. Incapacidad para acudir al Hospital
    12. Incapacidad para proporcionar el consentimiento informado
    E.5 End points
    E.5.1Primary end point(s)
    Efficiency variables
    Main variable:
    - Six-minute walking test or 6MWT

    Secondary variables:
    - Borg scale (after the 6-minute test)
    - Walking speed using the 10-meter test
    - ASIA motor scale
    - SCIM
    - Fatigue Scale FSS
    - Global Patient Change Impression (PGIC)
    - Quality of Life Scale
    - Number of patients with relevant clinical effect (>40 m or > 25% compared to baseline).

    Safety and tolerability variables
    - Incidence of SAE
    - Incidence of AE
    - Clinical evaluation, analysis, ECG, blood pressure and heart rate
    - Scales that assess spasticity (modified Ashworth), spasms (Penn), pain (EVA) and fall questionnaire
    - Clinical scales of anxiety and depression (Beck depression scale and HAD scale)
    - Fall questionnaire
    Parámetro principal de eficacia:
    • Test de la marcha de seis minutos o 6MWT.

    Variables de eficacia secundarias:
    • Escala Borg (después del 6MWT)
    • Velocidad de la marcha mediante el test de los 10 metros
    • Escala motora del ASIA
    • SCIM
    • Escala de fatiga FSS
    • Impresión global de cambio del paciente (PGIC)
    • Escala de calidad de vida (EQ-5D)
    • Número de pacientes que tenga efecto clínico relevante (>40 m o > 25% respecto a la basal).

    Variables de seguridad y tolerabilidad
    • Incidencia de AAG
    • Incidencia de AA
    • Evaluación clínica, analítica, ECG, tensión arterial y frecuencia cardiaca
    • Escalas que valoran espasticidad (Ashworth modificada), espasmos (Penn), el dolor (EVA) y cuestionario de caídas
    • Escalas clínicas de ansiedad y depresión (escala de depresión de Beck y escala HAD)
    • Cuestionario de caídas
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary and secondary variables will be obtained in the days prior to administration of the investigational drug (baseline) and successively on the 30th day (V3) after the start of treatment, the 60th day (V4), the 90th day (V5) and the 120th day (V6).
    Las variables primaria y secundarias se obtendrán en los días anteriores a la administración del medicamento en investigación (basal) y, sucesivamente el 30º día (V3) después del comienzo del tratamiento, el 60º día (V4), el 90º día (V5) y el 120º día (V6).
    E.5.2Secondary end point(s)
    N/A
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    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) Yes
    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 No
    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 concerned2
    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
    Ultima visita del ultimo sujeto
    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 months24
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state80
    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)
    N/A
    N/A
    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 Decision2022-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-29
    P. End of Trial
    P.End of Trial StatusOngoing
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