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    Summary
    EudraCT Number:2022-000490-13
    Sponsor's Protocol Code Number:EstuEla2022
    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:2022-03-24
    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 number2022-000490-13
    A.3Full title of the trial
    Treatment, with a full spectrum extract of
    cannabis, in refractory epilepsy
    associated with tuberous sclerosis complex (TSC)
    “Tratamiento, con extracto de
    cannabis
    de
    espectro completo, de la epilepsia refractaria
    asociada a complejo Esclerosis Tuberosa (CET)”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of difficult-to-control epilepsy associated with tuberous sclerosis complex
    Tratamiento de la epilepsia de difícil control, asociada a complejo de esclerosis tuberosa
    A.4.1Sponsor's protocol code numberEstuEla2022
    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 SponsorOILS4CURE S.L
    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 supportOILS4CURE S.L
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOILS4CURE
    B.5.2Functional name of contact pointTSC Clinical trials information
    B.5.3 Address:
    B.5.3.1Street AddressCalle los Yébenes 47
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28047
    B.5.3.4CountrySpain
    B.5.4Telephone number34676 933314
    B.5.6E-maillifeoilscbd@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 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 nameYCJ-01
    D.3.2Product code YCJ-01
    D.3.4Pharmaceutical form Oral drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Sublingual use
    Subretinal 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/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTHC
    D.3.9.1CAS number 64280-14-4
    D.3.9.3Other descriptive name11-NOR-DELTA(9)-TETRAHYDROCANNABINOL-9-CARBOXYLIC ACID
    D.3.9.4EV Substance CodeSUB33435
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    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 placeboOral drops
    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
    Refractory epilepsy in tuberous sclerosis complex
    Epilepsia refractaria en Complejo de Esclerosis Tuberosa
    E.1.1.1Medical condition in easily understood language
    Tuberosus Sclerosis Complex with epilepsy under diffcult control
    Esclerosis tuberosa con epilepsia de difícil control
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    evaluate changes in the number of seizures when administering complete cannabis extract, as a therapeutic active ingredient (API) in patients with epilepsy secondary to Tuberous Sclerosis Complex (TSC), refractory to treatment with antiepileptic drugs (FAEs) and/or other non-pharmacological treatments.
    Evaluar cambios en el número de crisis al administrar extracto completo de cannabis,como principio activo (API) terapéutico en pacientes con epilepsia secundaria a Complejo Esclerosis Tuberosa (CET), refractarios al tratamiento con fármacos antiepilépticos (FAEs) y/u otros tratamientos no farmacológicos.
    E.2.2Secondary objectives of the trial
    - Assess the safety and tolerability of the compound during the study period
    - Evaluate the improvement of the quality of life in control of epileptic crises, of the patient and consequently quality of life of relatives/caregivers.
    - Evaluate the improvement at the cognitive-behavioral level of patients and disruptive behaviors, autism.
    - Evaluar la seguridad y tolerabilidad del compuesto durante el periodo de estudio
    - Evaluar la mejora de la calidad de vida en control de crisis epilépticas, del paciente y en consecuencia calidad de vida de familiares /cuidadores.
    - Evaluar la mejoría a nivel cognitivo-conductual de los pacientes y conductas disruptivas, autismo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Confirmed diagnosis of TSC (by clinical criteria and/or genetic study)
    - Refractory epilepsy secondary to TSC, defined as epilepsy that does not respond successfully to traditional AEDs (2 or more), ketogenic diet, vagus nerve stimulator, and/or are not candidates for epilepsy surgery or persist with seizures after surgery surgical.
    - The minimum seizure frequency is 4 or more per month with observable external signs (loss of consciousness or motor component)
    - Stability in the dose of AEDs in the 4 weeks prior to the intervention with the oil enriched in CBD+THC, and ketogenic diet/programming of the device associated with the vagus nerve stimulator
    - A maximum number of 3 concomitant drugs at the beginning of the clinical trial.
    - Availability of caregivers to complete the "crisis diary" prior to inclusion in the study
    - Diagnóstico confirmado de CET (por criterios clínicos y/o estudio genético)
    - Epilepsia refractaria secundaria a CET, definida como aquella que no responde exitosamente a FAEs tradicionales (2 o más), dieta cetogénica, estimulador del nervio vago, y/o no sean candidatos a cirugía de la epilepsia o persistan con crisis posteriormente a la intervención quirúrgica.
    - La frecuencia mínima de crisis es de 4 o más al mes con signos externos observables (pérdida de conciencia o componente motor)
    - Estabilidad en la dosis de FAEs en las 4 semanas previas a la intervención con el aceite enriquecido en CBD+THC, y dieta cetogénica/programación del dispositivo asociado al estimulador del nervio vago sin cambios
    - Un número máximo de 3 fármacos concomitantes al comienzo del ensayo clínico.
    - Disponibilidad por parte de los cuidadores de completar el “diario de crisis” previo a la inclusión en el estudio
    E.4Principal exclusion criteria
    - Patients with an unconfirmed diagnosis, receiving corticosteroids, who did not go through previous therapeutic alternatives or did not correctly adhere to AEDs before being included in the study
    - Cardiac, renal, hepatic, pancreatic insufficiency, or hematological dysfunction with values ​​above the normal limits of creatinine and urea; values ​​2 times the normal limit of serum transaminases, lipase and amylase; platelets <80,000/mm3, and white blood cell count <3,000/mm3.
    - Severe uncontrolled medical condition such as: liver disease, cirrhosis, chronic hepatitis (hepatitis B or C), uncontrolled diabetes (defined as serum glucose >150 mg%), active infections (chronic or acute) or severe uncontrolled infections, bleeding assets.
    - Patients whose families do not agree to comply with the requirements and visits of the study, or at the discretion of the treating physician present a high risk of non-compliance with the protocol.
    - Allergy to any of the components of cannabis oil.
    - Family history of schizophrenia or personal history of attempted suicide.
    - Patients who changed the medication or dose of AEDs during the 30 days prior to the start of the study or DC/ENV
    - Pacientes con diagnóstico no confirmado, que reciben corticoides, que no pasaron por las alternativas terapéuticas previas o no adhirieron correctamente a los FAEs antes de ser incluidos en el estudio
    - Insuficiencia cardíaca, renal, hepática, pancreática, o disfunción hematológica con valores sobre los límites normales de creatinina y urea; valores 2 veces el límite normal de transaminasas, lipasa y amilasa sérica; plaquetas < 80000/mm3, y recuento de glóbulos blancos <3000/mm3.
    - Condición médica severa no controlada como: enfermedad hepática, cirrosis, hepatitis crónica (hepatitis B o C), diabetes no controlada (definida como glucosa sérica >150 mg%), infecciones activas (crónicas o agudas) o infecciones severas no controladas, sangrados activos.
    - Pacientes cuyas familias no accedan a cumplir con los requerimientos y visitas del estudio, o a criterio del médico tratante presenten alto riesgo de incumplimiento del protocolo.
    - Alergia a alguno de los componentes del aceite de cannabis.
    - Antecedentes familiares de esquizofrenia o antecedentes personales de intento de suicidio.
    - Pacientes que cambiaron la medicación o dosis de FAEs durante los 30 días previos al inicio del estudio o dieta cetogenica o estimulador vagal
    - Embarazo.
    E.5 End points
    E.5.1Primary end point(s)
    Comparison in the number of monthly seizures between the two groups and with the baseline period.
    Comparación en el número de crisis mensuales entre los dos grupos y con el periodo basal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    monthly
    mensualmente
    E.5.2Secondary end point(s)
    reduction in the number of monthly seizures reported by parents compared to the standardized record provided prior to the start of the study for seizure frequency.
    The crisis diary will be reviewed at each visit.

    -Response rate: Responders will be considered those patients who achieve a reduction in the number of crises of at least 50%
    -Proportion of patients free of seizures: defined as no seizures of any kind during the duration of the study or a period of time that doubles the baseline maximum interval between seizures (International League of Epilepsy, ILAE).
    -Maximum interval between crises: obtained from the schedule documented in the crisis record for each period prior to each control.
    -Effect on seizure type control: Focal with compromised state of consciousness, focal without compromised state of consciousness, focal secondarily generalized and epileptic spasms
    reducción en el número de crisis mensuales reportadas por los padres respecto al registro estandarizado entregado previo al inicio del estudio para la frecuencia de crisis.
    El diario de crisis será revisado en cada visita.

    -Tasa de respuesta: se considerará respondedores a aquellos pacientes que alcancen una reducción en el número de crisis de al menos 50%
    -Proporción de pacientes libres de crisis: definido como ninguna convulsión de ningún tipo durante la duración del estudio o un período de tiempo que duplique el intervalo máximo intercrisis basal (Liga Internacional de Epilepsia, ILAE).
    -Intervalo máximo intercrisis: obtenido del horario documentado en el registro de crisis para cada período previo a cada control.
    -Efecto en control del tipo de crisis: Focales con compromiso del estado de conciencia, focales sin compromiso del estado de conciencia, focales secundariamente generalizadas y espasmos epilépticos
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the beginning and the end
    Al comienzo y al final del estudio
    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 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) 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 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 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 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
    after taking the drug for 18/24 weeks.
    If the expected effectiveness is demonstrated, the sponsor will administer the treatment until it is marketed.
    tras la toma del medicamento durante 18/24 semanas.

    si se ha demostrado la efectividad esperada, él sponsor administrará el tratamiento hasta la comercialización del mismo
    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 months6
    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 Yes
    F.1.1Number of subjects for this age range: 58
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 28
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 24
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    intellectual disability associated with tuberous sclerosis
    Personas con discapacidad intelectual asociada a la esclerosis tuberosa
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state82
    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'. usual clinical practice
    Ninguno. Práctica clínica habitual.
    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 Decision2023-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-29
    P. End of Trial
    P.End of Trial StatusOngoing
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