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    Summary
    EudraCT Number:2021-000214-42
    Sponsor's Protocol Code Number:755-201-EB
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-000214-42
    A.3Full title of the trial
    A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (cannabinol) Cream in Patients with Epidermolysis Bullosa.
    Studio di fase 2, randomizzato, in doppio cieco, controllato con veicolo, teso a valutare la crema INM-755 (cannabinolo) per uso topico in pazienti con epidermolisi bollosa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    INM-755 cream for patients with EB.
    Crema INM-755 per pazienti con EB
    A.3.2Name or abbreviated title of the trial where available
    Refer to the protocol
    Fare riferimento al protocollo
    A.4.1Sponsor's protocol code number755-201-EB
    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 SponsorInMed Pharmaceuticals Inc.
    B.1.3.4CountryCanada
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInMed Pharmaceuticals Inc.
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInMed Pharmaceuticals Inc.
    B.5.2Functional name of contact pointClinical Research Executive
    B.5.3 Address:
    B.5.3.1Street Address815 W Hastings St, #310
    B.5.3.2Town/ cityVancouver, British Colombia
    B.5.3.3Post codeV6C1B4
    B.5.3.4CountryCanada
    B.5.4Telephone number000000
    B.5.5Fax number000000
    B.5.6E-mailclinical@inmedpharma.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 nameCannabinol (CBN)
    D.3.2Product code [INM-755]
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCANNABINOL
    D.3.9.1CAS number 521-35-7
    D.3.9.2Current sponsor codeINM-755
    D.3.9.4EV Substance CodeSUB06074MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboCream
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Epidermolysis bullosa
    Epidermolisi bollosa
    E.1.1.1Medical condition in easily understood language
    Epidermolysis bullosa
    Epidermolisi bollosa
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10014989
    E.1.2Term Epidermolysis bullosa
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To evaluate the safety of INM-755 cream in patients with EB.
    - To obtain preliminary evidence of efficacy of INM-755 cream on wound and non-wound
    affected skin areas in patients with EB.
    •Valutare la sicurezza della crema INM-755 in pazienti con epidermolisi bollosa (EB).
    •Ottenere l'evidenza preliminare di efficacia della crema INM-755 su aree cutanee con/senza lesioni in pazienti con EB.
    E.2.2Secondary objectives of the trial
    - To assess systemic exposure to cannabinol in a subset of patients.
    Valutare l'esposizione sistemica al cannabinolo in un sottogruppo di pazienti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Individuals must meet all of the following criteria to be included in the study:
    1. Male or female patients aged =18 years with documented diagnosis of any of the following types of inherited EB:
    • EB simplex
    • Junctional EB
    • Dystrophic EB
    • Kindler EB
    Enrolment will be extended to patients =12 years old and <18 years old after positive opinion of a DMC after their review of safety and tolerability data from at least 4 adult patients who have completed at least 2 weeks of study treatment.
    2. Presence of at least 1 pair of index areas that are well matched in terms of type(s) of EB sign or symptom, severity, and size. To be eligible, the pair of index areas must be either non-wound areas with symptom of itch or wounds (that may or may not have associated pain or itch). Up to 2 pairs of index areas (1 pair of non-wound and 1 pair of wound index areas) can be selected and treated in each individual patient.
    For non-wound itch index areas, both areas should meet the following criteria:
    • Chronic itch, not associated with a wound, with a score =40 mm on a 100 mm VAS at the Screening Visit and with an average score =40 mm during the 7 days before the Baseline Visit, and present for the majority of time over the 6 weeks before to the Baseline Visit
    • Absence of wounds at the Screening and Baseline Visits that could qualify as an index wound (see below) in the index areas or that require wound dressing.
    • The area cannot also have a wound that has healed (re-epithelialised) within the past 3 weeks prior to Screening.
    • Extension of each index area to be treated should not exceed 20% of BSA and should not be less than 1% of BSA
    • A difference in the index areas to be treated not larger than 2-fold the area of the smallest index non-wound itch area at the Screening Visit
    • Additional signs or symptoms of EB other than itch from selected index areas do not need to be matched.
    If the pair of index areas are wounds, both wounds should meet all following characteristics:
    • Wounds with a surface area =5 cm2 and =50 cm2 inclusive at the Screening and Baseline Visits and aged =3 weeks at the Screening Visit
    • At Baseline Visit, each index wound should not present a surface reduction =30% from the Screening Visit
    • To be considered well-matched the index wounds must have:
    a. a difference in the surface area not larger than 2-fold the surface of the smallest index wound at the Screening Visit
    b. both must fit into the same duration window of either =3 weeks to 3 months before the Screening Visit or >3 months
    c. not located at anatomical sites with high likelihood of accidental trauma (e.g., knees, elbows)
    3. Female patients of childbearing potential or men whose sexual partners are women of childbearing potential (WOCBP) must be able and willing to use at least 1 method of contraception until the patient’s last study visit. The following are permitted contraceptive methods: intrauterine device, hormonal contraceptives (e.g., oral, patch, or injectable), male vasectomy (if vasectomy was medically confirmed). Abstinence from heterosexual intercourse is acceptable when this is the usual lifestyle of the patient. A female patient is considered not of childbearing potential when postmenopausal (at least 12 consecutive months without menses without an alternative medical cause) or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, or bilateral oophorectomy with or without hysterectomy).
    4. If the patient is a female of childbearing potential, patient should have a negative urine pregnancy test result at Screening and Baseline Visits.
    5. Must be willing to provide written consent (or assent from the patient and written informed consent from the parent or guardian for patients aged <18 years) and to comply with the requirements of the study protocol.
    Gli individui devono soddisfare tutti i seguenti criteri per poter partecipare allo studio:
    1.Pazienti maschi o femmine di età =18 anni con diagnosi documentata di uno qualsiasi dei seguenti tipi di EB ereditaria:
    •EB semplice
    •EB giunzionale
    •EB distrofica
    •Sindrome di Kindler
    L'arruolamento sarà esteso ai pazienti di età =12 e <18 anni dopo parere favorevole di un DMC dopo l'analisi dei dati sulla sicurezza e sulla tollerabilità di un numero minimo di 4 pazienti adulti che avranno completato almeno 2 settimane di trattamento dello studio.
    2.Presenza di almeno 1 coppia di aree indice corrispondenti in termini di tipo/i di segni e sintomi di EB, gravità e dimensione. Per essere ritenuti eleggibili allo studio, la coppia di aree indice deve essere composta da aree senza lesione con sintomi di prurito o aree con lesione (che possono o meno essere associate a dolore o prurito). Possono essere selezionate e trattate fino a un massimo di 2 coppie di aree indice (1 coppia di aree indice senza lesione e 1 coppia di aree indice con lesione) per ciascun singolo paziente.
    Per le aree indice senza lesione con prurito, entrambe le aree devono soddisfare i seguenti criteri: • Prurito cronico, non associato a una lesione, con un punteggio =40 mm secondo la VAS da 100 mm alla visita di screening con un punteggio medio =40 mm nei 7 giorni che precedono la visita basale e presente per la maggior parte del tempo nelle 6 settimane precedenti alla visita basale.•Assenza di lesioni nelle aree indice alle visite di screening e basale che potrebbero essere classificate come lesioni indice (vedere sotto) o che richiedano medicazione.•Le aree non possono presentare una lesione guarita (riepitelizzata) nelle 3 settimane che precedono lo screening.•L'estensione di ciascuna area indice da trattare non deve superare il 20% della superficie corporea (Body Surface Area, BSA) né essere inferiore all'1% della BSA.•Una differenza delle aree indice da trattare non superiore a 2 volte la superficie dell'area indice senza lesione con prurito più piccola alla visita di screening.•Ulteriori segni o sintomi dell'EB diversi dal prurito a livello delle aree indice selezionate non devono corrispondere.Se la coppia delle aree indice presenta lesioni, entrambe le lesioni devono soddisfare le seguenti caratteristiche:•Lesioni con una superficie =5 cm2 e =50 cm2 (inclusi) alle visite di screening e basale e di età =3 settimane alla visita di screening •Alla visita basale ciascuna lesione indice non deve presentare una riduzione della superficie =30% rispetto alla visita di screening •Per essere considerate lesioni corrispondenti, le lesioni indice devono presentare: a.una differenza della superficie non superiore a 2 volte la superficie della lesione indice più piccola alla visita di screening;b.entrambe devono rientrare nella stessa finestra di durata da =3 settimane a 3 mesi prima della visita di screening o >3 mesi; c.non essere posizionate in aree anatomiche con elevata probabilità di traumi accidentali (per es., ginocchia, gomiti). 3.Le pazienti in grado di procreare o i pazienti con partner in grado di procreare devono potere ed essere disposti a utilizzare almeno 1 metodo contraccettivo fino all'ultima visita dello studio del paziente. Per i restanti criteri èm possibile fare riferimento alla sinossi
    E.4Principal exclusion criteria
    Individuals meeting any of the following criteria at Screening or Baseline are ineligible to participate in this study:
    1. EB index areas have evidence of infection.
    2. Patient has evidence of a systemic infection or has used systemic antibiotics for EB-related infections within 7 days before the Baseline Visit.
    3. Administration of systemic corticosteroids within 30 days or of topical (except ophthalmic) corticosteroids on chosen index areas within 14 days before the Baseline Visit. Corticosteroids for inhalation or intranasal use are permitted provided they are taken at a stable dosing.
    4. Immunosuppressive therapy or cytotoxic chemotherapy within 60 days before the Baseline Visit.
    5. Use of any high potency opioid within 30 days prior to Baseline Visit.
    6. Use of cannabis, cannabis extracts, or any cannabinoid products for medical or recreational use by any route of administration within 2 weeks prior to the Baseline Visit. The patient can be using the cannabinoid-containing product at Screening but must commit to avoiding cannabinoid use in the prescribed timeframe.
    7. Patient has undergone stem cell transplant or gene therapy for the treatment of inherited EB.
    8. History of malignancy including basal cell carcinomas and squamous cell carcinomas.
    9. Arterial or venous disorder resulting in ulcerated wounds.
    10. Uncontrolled diabetes mellitus.
    11. Presence of chronic pruritus believed to be primarily attributable to concomitant pathologies or conditions other than EB (e.g., renal or cholestatic pathologies).
    12. Patient has received blood transfusion to treat anaemia within the past 3 months.
    13. Patient has received any investigational drug within 30 days or 5 half-lives (whichever is longer) before the Baseline Visit.
    14. Patient has an underlying condition which in the opinion of the investigator places the patient at unacceptable risk.
    15. Women who are pregnant, breastfeeding (lactating), or planning to become pregnant during the study.
    16. Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
    Gli individui che soddisfano uno qualsiasi dei seguenti criteri alle visite di screening o basale saranno ritenuti ineleggibili alla partecipazione allo studio:
    1. Aree indice di EB con evidenza di infezione.
    2. Pazienti con comprovata infezione sistemica o che hanno ricevuto antibiotici sistemici per infezioni correlate a EB nei 7 giorni che precedono la visita basale.
    3. Somministrazione di corticosteroidi sistemici nei 30 giorni che precedono la visita basale o di corticosteroidi topici (eccetto per uso oftalmico) sull'area indice selezionata nei 14 giorni che precedono la visita basale. Corticosteroidi per inalazione o per uso intranasale sono consentiti posto che siano assunti a una dose stabile.
    4. Terapia immunosoppressiva o chemioterapia citotossica nei 60 giorni che precedono la visita basale.
    5. Utilizzo di qualsiasi oppioide a elevata potenza nei 30 giorni che precedono la visita basale.
    6. Uso di cannabis, estratti di cannabis o qualsiasi altro prodotto cannabinoide per uso medico o ricreativo per qualsiasi via di somministrazione nelle 2 settimane che precedono la visita basale. Il paziente può utilizzare prodotti contenenti cannabinoidi allo screening, ma si deve impegnare a evitarne l'uso nell'intervallo di tempo stabilito.
    7. Pazienti sottoposti a trapianto di cellule staminali o a terapia genica per il trattamento dell'EB ereditaria.
    8. Anamnesi di neoplasia, inclusi i carcinomi a cellule basali e a cellule squamose.
    9. Patologie arteriose o venose che portano a ulcerazione delle lesioni.
    10. Diabete mellito non controllato.
    11. Presenza di prurito cronico ritenuto attribuibile principalmente a patologie concomitanti o condizioni diverse dall'EB (per es., patologie renali o colestatiche).
    12. Trasfusione di sangue per il trattamento dell'anemia nei 3 mesi precedenti.
    13. Trattamento con qualsiasi farmaco sperimentale nei 30 giorni o nelle 5 emivite (a seconda di quale dei due periodi sia più lungo) prima della visita basale.
    14. Condizione sottostante che, secondo il giudizio dello sperimentatore, potrebbe porre il paziente a un rischio inaccettabile.
    15. Donne in gravidanza, in allattamento o che stiano pianificando di iniziare una gravidanza durante lo studio.
    16. Paziente considerato dallo sperimentatore per qualsiasi ragione un candidato non idoneo allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary safety endpoints are:
    • Incidence of treated index areas with erythema, oedema, scaling, and stinging/burning identified from local tolerability assessment (LTA) by type of treatment and severity
    • Treatment-emergent local adverse event (AE) incidence, severity, and relationship with treatment
    Gli endpoint primari di sicurezza sono:
    •Frequenza di eritema, edema, desquamazione e sensazione pungente/urente nelle aree indice trattate, identificate con la valutazione della tollerabilità locale (Local Tolerability Assessment, LTA) in base al tipo di trattamento e gravità
    •Frequenza di eventi avversi (Adverse Event, AE) locali emergenti dal trattamento, gravità e correlazione con il trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through out the study
    Durante tutto lo studio
    E.5.2Secondary end point(s)
    Other safety endpoints are:
    • Treatment-emergent systemic AE incidence, severity, and relationship with treatment
    • Change from Baseline (CFB) in vital signs
    • Incidence of treatment-emergent abnormal physical examination findings
    Efficacy Endpoints
    Preliminary evidence of efficacy will be evaluated based on the following endpoints as applicable:
    Non-wound Itch:
    • CFB in weekly average non-wound itch severity summarised from daily assessments by the patient using a 100 mm visual analogue scale (VAS)
    • Proportion of non-wound itch index areas achieving a 20 mm, 30 mm, or >30 mm reduction of itch VAS from Baseline to End of Treatment (EOT)
    • Patient's Impression of Change of Non-wound Itch (PIC-I) as assessed by the Dynamic Pruritus Scale (DPS) at each index area after 2 weeks and 4
    weeks of treatment
    Wound Surface Area:
    • Absolute and percent CFB in surface area of each index wound at the scheduled visits
    • Incidence of at least 25%, 50%, 75%, and 100% reduction in surface area from Baseline and incidence of first complete closure (defined as
    complete re-epithelialisation without drainage) of each index wound at the scheduled visits
    • Time to achieve 50% reduction from Baseline in surface area of each index wound
    • Time to achieve complete closure of each index wound
    Procedural Wound Pain:
    • CFB in weekly average index wound pain score associated with dressing change (procedural pain) summarised from assessments by the patient using a 100 mm VAS
    • Proportion of index wounds with associated procedural pain achieving a 20 mm, 30 mm, or >30 mm reduction of pain VAS from Baseline to EOT
    • Patient’s Impression of Change-Procedural Pain (PIC-PP) for each wound index area after 2 weeks and 4 weeks of treatment
    Background Wound Pain:
    • CFB in weekly average index wound pain score not associated with dressing change (background pain) summarised from daily assessments by
    the patient using a 100 mm VAS
    • Proportion of index wounds with background pain achieving a 20 mm, 30 mm, or >30 mm reduction of pain severity from Baseline to EOT
    • Patient’s Impression of Change-Background Pain (PIC-BP) for each wound index area after 2 weeks and 4 weeks of treatment
    Wound Itch:
    • CFB in weekly average wound itch summarised from daily assessments by the patient using a 100 mm VAS
    • Proportion of index wounds with associated itch achieving a 20 mm, 30 mm, or >30 mm reduction of itch severity from Baseline to EOT
    • Patient’s Impression of Change-Wound Itch (PIC-WI) for each index area after 2 weeks and 4 weeks of treatment
    Pharmacokinetic Endpoint
    The pharmacokinetic (PK) endpoint of this study is systemic exposure to cannabinol (CBN) measured at completion of treatment (in a subset of patients).
    Altri endpoint di sicurezza sono:
    -Frequenza di AE sistemici emergenti dal trattamento, gravità e correlazione con il trattamento
    -Cambiamento rispetto al basale (Change From Baseline, CFB) dei parametri vitali
    -Frequenza di riscontri anormali all'esame obiettivo emergenti dal trattamento
    Endpoint di efficacia
    L'evidenza preliminare di efficacia sarà valutata in base ai seguenti endpoint, come pertinente:
    Prurito nell'area senza lesione:
    •CFB della gravità del prurito medio settimanale nell'area senza lesione riepilogato da valutazioni giornaliere da parte del paziente utilizzando una scala visuo-analogica (Visual Analogue Scale, VAS) da 100 mm
    •Percentuale di aree indice senza lesione con prurito che raggiungono una riduzione di 20 mm, 30 mm o >30 mm secondo la VAS del prurito dal basale a fine trattamento (End of Treatment, EOT)
    •Impressione del paziente relativa al cambiamento del prurito nell'area senza lesione (Patient's Impression of Change of non-wound Itch, PIC-I) valutata utilizzando la scala DPS (Dynamic Pruritus Scale) per la misurazione dinamica del prurito in ciascuna area indice dopo 2 e 4 settimane di trattamento
    Superficie dell'area con lesione:
    •CFB assoluto e percentuale della superficie di ciascuna lesione indice alle visite programmate
    •Frequenza di riduzione della superficie di almeno il 25%, 50%, 75% e 100% rispetto al basale e frequenza della prima chiusura completa (definita come riepitelizzazione completa senza secrezione) di ciascuna lesione indice alle visite programmate
    •Tempo al raggiungimento della riduzione del 50% della superficie di ciascuna lesione indice rispetto al basale
    •Tempo al raggiungimento della chiusura completa di ciascuna lesione indice
    Dolore procedurale alla lesione:
    •CFB del punteggio medio settimanale del dolore alla lesione indice associato al cambio della medicazione (dolore procedurale) riepilogato mediante le valutazioni dei pazienti utilizzando una VAS da 100 mm
    •Percentuale di lesioni indice con dolore procedurale associato che raggiungono una riduzione del dolore di 20 mm, 30 mm o >30 mm secondo la VAS del dolore dal basale a EOT
    • Impressione del paziente relativa al cambiamento del dolore procedurale (Patient's Impression of Change-Procedural Pain, PIC-PP) per ciascuna area indice con lesione dopo 2 e 4 settimane di trattamento
    Dolore di fondo alla lesione:
    •CFB del punteggio medio settimanale del dolore alla lesione indice non associato al cambio della medicazione (dolore di fondo) riepilogato mediante le valutazioni giornaliere dei pazienti utilizzando la VAS da 100 mm
    •Percentuale di lesioni indice con dolore di fondo che raggiungono una riduzione dell'intensità del dolore di 20 mm, 30 mm o >30 mm dal basale a EOT
    •Impressione del paziente relativa al cambiamento del dolore di fondo (Patient's Impression of Change-Background Pain, PIC-BP) per ciascuna area indice con lesione dopo 2 e 4 settimane di trattamento
    Prurito all'area con lesione:
    •CFB del prurito medio settimanale nell'area con lesione riepilogato da valutazioni giornaliere da parte del paziente utilizzando la VAS da 100 mm
    •Percentuale di lesioni indice con prurito associato che raggiungono una riduzione dell'intensità del prurito di 20 mm, 30 mm o >30 mm dal basale a EOT
    •Impressione del paziente relativa al cambiamento del prurito alla lesione (Patient's Impression of Change-Wound Itch, PIC-WI) per ciascuna area indice dopo 2 e 4 settimane di trattamento.
    Endpoint farmacocinetico
    L'endpoint farmacocinetico (PK) di questo studio è l'esposizione sistemica a cannabinolo (CBN) misurata al completamento del trattamento (in un sottogruppo di pazienti).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through out the study
    Durante tutto lo studio
    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 Yes
    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) No
    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 Yes
    E.8.1.7.1Other trial design description
    Confronto intraindividuale
    Intra individual comparison
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    France
    Germany
    Greece
    Israel
    Italy
    Serbia
    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
    Last visit last subject
    Ultima visita ultimo soggetto
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 8
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 11
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Adolescents 12-17 years old
    Adolescenti tra i 12 e i 17 anni
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 20
    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)
    Patients will revert to their normal standard of care.
    I pazienti torneranno al loro normale standard di cura.
    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 Decision2021-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-23
    P. End of Trial
    P.End of Trial StatusOngoing
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