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    Summary
    EudraCT Number:2022-001777-31
    Sponsor's Protocol Code Number:IG2021370
    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:2023-01-31
    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 number2022-001777-31
    A.3Full title of the trial
    Pilot study on the effect of cannabinoids THC + CBD on resistant spasticity in patients with chronic spinal cord injury.
    Estudio piloto sobre el efecto de los cannabinoides THC + CBD en la espasticidad resistente en pacientes con lesión medular crónica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot study on the effect of cannabinoids THC + CBD on resistant spasticity in patients with chronic spinal cord injury.
    Estudio piloto sobre el efecto de los cannabinoides THC+CBD en la espasticidad resistente en pacientes con lesión medular crónica
    A.4.1Sponsor's protocol code numberIG2021370
    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 de Neurorrehabilitación Institut Guttmann
    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 supportAlmirall S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDynamic S.L.U. (Evidenze Clinical Research)
    B.5.2Functional name of contact pointDepartamento operaciones
    B.5.3 Address:
    B.5.3.1Street AddressAv. Josep Tarradellas, 8-10
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08209
    B.5.3.4CountrySpain
    B.5.6E-mailensayosclinicos@evidenze.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 Sativex 2,7 mg / 2,5 mg Solución para pulverización bucal
    D.2.1.1.2Name of the Marketing Authorisation holderGW Pharma (International) B.V.
    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 nameSativex 2,7 mg / 2,5 mg Solución para pulverización bucal
    D.3.4Pharmaceutical form Oral spray, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCannabidiol
    D.3.9.1CAS number 13956-29-1
    D.3.9.4EV Substance CodeSUB26600
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdelta‑9‑tetrahidrocannabinol (THC)
    D.3.9.3Other descriptive nameDelta(9)-tetrahydrocannabinolic acid
    D.3.9.4EV Substance CodeSUB190924
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.7
    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 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
    Pilot study on the effect of THC+CBD cannabinoids on resistant spasticity in patients with chronic spinal cord injury.
    Estudio piloto sobre el efecto de los cannabinoides THC+CBD en la espasticidad resistente en pacientes con lesión medular crónica.
    E.1.1.1Medical condition in easily understood language
    Pilot study on the effect of THC+CBD cannabinoids on resistant spasticity in patients with chronic spinal cord injury.
    Estudio piloto sobre el efecto de los cannabinoides THC+CBD en la espasticidad resistente en pacientes con lesión medular crónica.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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 assess the clinical response to the anti-spasticity drug delta 9-tetrahydrocannabinol (THC) + cannabidiol (CBD) oral spray solution (Sativex®) in resistant spasticity due to spinal cord injury (SCI), using the numerical rating scale (NRS).
    Evaluar la respuesta clínica al fármaco antiespástico delta 9-tetrahidrocannabinol (THC) + cannabidiol (CBD) solución para pulverización bucal (Sativex®) en la espasticidad resistente debida a lesión medular (LM), mediante la escala de valoración numérica (NRS).
    E.2.2Secondary objectives of the trial
    To assess the effect of treatment on muscle spasticity with the modified Ashworth spasticity scale (MAS).
    To assess the effect of treatment on spasm frequency with the Penn spasm scale.
    To assess the effect of treatment on the patient's impression of change with the PGIC scale.
    To assess changes in movement patterns, using hand-held sensors.
    To assess the effect of treatment on neuropathic pain symptoms, according to the NPSI scale.
    To assess the effect of treatment on sleep symptoms related to spasticity in LM, according to the PSQI questionnaire.
    To assess the effect of treatment on mood, according to the PHQ-9 scale.
    To assess the effect of treatment on the functional independence of the patient, according to the SCIM III scale.
    To assess the effect of treatment on the patient's quality of life, according to the WHOQoL-BREF scale.
    To assess the safety of treatment for spasticity in patients with chronic LM.
    Evaluar el efecto del tratamiento en la espasticidad muscular con la escala de espasticidad de Ashworth modificada (MAS).
    Evaluar el efecto del tratamiento en la frecuencia de los espasmos con la escala de espasmos de Penn.
    Evaluar el efecto del tratamiento en la impresión de cambio del paciente con la escala PGIC.
    Evaluar los cambios en los patrones de movimiento, mediante sensores portátiles.
    Evaluar el efecto del tratamiento en los síntomas del dolor neuropático, según la escala NPSI.
    Evaluar el efecto del tratamiento en los síntomas de sueño relacionados con la espasticidad en la LM, según el cuestionario PSQI.
    Evaluar el efecto del tratamiento en el estado de ánimo, según la escala PHQ-9.
    Evaluar el efecto del tratamiento en la independencia funcional del paciente, según la escala SCIM III.
    Evaluar el efecto del tratamiento en la calidad de vida del paciente, según la escala WHOQoL-BREF.
    Evaluar la seguridad del tratamiento para la espasticidad en pacientes con LM crónica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who give informed consent to participate in the study.
    2. Patients over 18 years of age.
    3. Patients with traumatic or non-traumatic LM, ASIA A, B, C or D, of more than 6 months of evolution.
    4. Patients with moderate to severe spasticity, according to the modified Ashworth spasticity scale (≥ 2) or ≥ 4 on the NRS scale.
    5. Patients with insufficient response to the usual combination treatment of baclofen and another anti-spasticity drug: tizanidine, diazepam, clonazepam, gabapentinoids (gabapentin, pregabalin).
    6. Patients who have reached a daily dose of baclofen ≥100 mg, according to the centre's standard practice, or have not tolerated the prescribed dose.
    1. Pacientes que otorgan el consentimiento informado para participar en el estudio.
    2. Pacientes mayores de 18 años.
    3. Pacientes con LM traumática o no traumática, ASIA A, B, C o D, de más de 6 meses de evolución.
    4. Pacientes con grado de espasticidad moderada a grave, según la escala de espasticidad modificada de Ashworth (≥ 2) o ≥ 4 en la escala NRS.
    5. Pacientes que no tienen respuesta suficiente al tratamiento habitual de combinación de baclofeno y otro fármaco antiespástico: tizanidina, diazepam, clonazepam, gabapentinoides (gabapentina, pregabalina).
    6. Pacientes que han alcanzado una dosis diaria de baclofeno ≥100 mg, según la práctica habitual del centro, o no han tolerado la dosis pautada.
    E.4Principal exclusion criteria
    1. Patients allergic to the drug.
    2. Patients with cauda equina injury or other non-traumatic or non-traumatic non-medullary spinal cord injuries of less than 6 months of evolution.
    3. Patients with severe psychiatric problems in treatment according to DSM-5 criteria.
    4. Patients with comorbidities that contraindicate the use of the cannabinoids in the study according to the technical data sheet.
    5. Patients with a previous history of drug abuse.
    6. Patients who have consumed cannabis in the last month.
    7. Pregnant or breastfeeding patients.
    8. Patients with an intrathecal baclofen pump.
    1. Pacientes alérgicos al fármaco.
    2. Pacientes con lesión de cola de caballo u otras lesiones no medulares traumáticas o no traumáticas de menos de 6 meses de evolución.
    3. Pacientes con problemas psiquiátricos graves en tratamiento según criterios DSM-5.
    4. Pacientes con comorbilidades que contraindiquen el uso de los cannabinoides del estudio según ficha técnica.
    5. Pacientes con historia previa de abuso de drogas.
    6. Pacientes que han consumido cannabis durante el último mes.
    7. Pacientes embarazadas o en periodo de lactancia.
    8. Pacientes portadores de bomba de baclofeno intratecal.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients achieving at least a 20% reduction from baseline on the NRS numerical rating scale (0-10) for spasticity symptoms. Treatment benefit will be assessed 3 months after starting treatment.
    Porcentaje de pacientes que logran una reducción de al menos el 20% respecto a la situación basal en la escala de valoración numérica NRS (0-10) para síntomas de espasticidad. El beneficio del tratamiento se evaluará a los 3 meses de iniciar el tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months after the start of treatment.
    A los 3 meses de iniciar el tratamiento.
    E.5.2Secondary end point(s)
    - Mean change in NRS spasticity score 0-10 at 4 weeks and 3 months after starting treatment.
    - Percentage of patients with at least 30% improvement from their baseline spasticity score on the NRS 0-10 scale (clinically relevant response) at 4 weeks and 3 months after starting treatment.
    - Mean change in MAS score at 4 weeks and 3 months after starting treatment.
    - Mean change in Penn Spasm Scale score at 4 weeks and 3 months after starting treatment.
    - Patient Global Impression of Change (PGIC) at 4 weeks and 3 months after starting treatment.
    - Changes in movement patterns, collected by portable ZurichMove IMU sensors (Zurich, Switzerland. https://zurichmove.com/), 3 months after starting treatment.
    - Change in neuropathic pain symptom intensity, according to NPSI, 4 weeks and 3 months after starting treatment.
    - Change in sleep pattern, according to PSQI, 4 weeks and 3 months after starting treatment.
    - Change in mood, according to PHQ-9 scale, at 4 weeks and 3 months after starting treatment.
    - Change in functional independence, according to the SCIM III scale, at 4 weeks and 3 months after starting treatment.
    - Change in quality of life, according to the WHOQoL-BREF scale, at 4 weeks and 3 months after starting treatment.
    - Safety of THC+CBD treatment will be assessed by collecting adverse events.
    • Cambio medio en la puntuación de la escala NRS de espasticidad 0-10 a las 4 semanas y 3 meses de iniciar el tratamiento.
    • Porcentaje de pacientes que presenta una mejoría de al menos el 30% respecto a la puntuación de su espasticidad basal en la escala NRS 0-10 (respuesta clínicamente relevante) a las 4 semanas y 3 meses de iniciar el tratamiento.
    • Cambio medio en la puntuación en la escala MAS a las 4 semanas y 3 meses de iniciar el tratamiento.
    • Cambio medio en la puntuación en la escala de espasmos de Penn, a las 4 semanas y 3 meses de iniciar el tratamiento.
    • Impresión Global de Cambio de los pacientes (PGIC) a las 4 semanas y 3 meses de iniciar el tratamiento.
    • Cambios en las pautas de movimiento, recogidos por sensores portátiles ZurichMove IMU (Zurich, Switzerland. https://zurichmove.com/), a los 3 meses de iniciar el tratamiento.
    • Cambio en la intensidad de los síntomas del dolor neuropático, según NPSI, a las 4 semanas y 3 meses de iniciar el tratamiento.
    • Cambio en el patrón del sueño, según PSQI, a las 4 semanas y 3 meses de iniciar el tratamiento.
    • Cambio en el estado de ánimo, según la escala PHQ-9, a las 4 semanas y 3 meses de iniciar el tratamiento.
    • Cambio en la independencia funcional, según la escala SCIM III, a las 4 semanas y 3 meses de iniciar el tratamiento.
    • Cambio en la calidad de vida, según la escala WHOQoL-BREF, a las 4 semanas y 3 meses de iniciar el tratamiento.
    • La seguridad del tratamiento con THC+CBD se evaluará mediante la recogida de acontecimientos adversos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 4 weeks and 3 months after the start of treatment.
    A las 4 semanas y a los 3 meses de iniciar tratamiento.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    Última visita del último voluntario
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    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: 20
    F.1.3Elderly (>=65 years) No
    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 state20
    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 Decision2023-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-18
    P. End of Trial
    P.End of Trial StatusOngoing
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