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    Summary
    EudraCT Number:2022-000317-14
    Sponsor's Protocol Code Number:RAD-GRIN-101
    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:2022-11-04
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2022-000317-14
    A.3Full title of the trial
    A Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms of Multiple Individually Titrated Doses of Radiprodil in Children with GRIN-related Disorder
    Studio multicentrico per valutare la sicurezza, la tollerabilità, la farmacocinetica e l’effetto su crisi epilettiche e sintomi comportamentali di dosi multiple titolate individualmente di radiprodil in bambini con disturbo correlato a GRIN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study with Radiprodil in Children with GRIN-related Disorder
    Studio con Radiprodil in bambini con disturbo correlato al GRIN
    A.3.2Name or abbreviated title of the trial where available
    Study with Radiprodil in Children with GRIN-related Disorder
    Studio con Radiprodil in bambini con disturbo correlato al GRIN
    A.4.1Sponsor's protocol code numberRAD-GRIN-101
    A.5.4Other Identifiers
    Name:IND NumberNumber:160112
    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 SponsorGRIN Therapeutics Inc
    B.1.3.4CountryUnited States
    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 supportGRIN Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGRIN Therapeutics, Inc.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address101 Main Street, Suite 1210
    B.5.3.2Town/ cityCambridge Massachusetts
    B.5.3.3Post code02142
    B.5.3.4CountryUnited States
    B.5.6E-mailTamara.Agajanov@grintherapeutics.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 nameRadiprodil
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Granules for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRadiprodil
    D.3.9.1CAS number 496054-87-6
    D.3.9.2Current sponsor codeRadiprodil Form A
    D.3.9.4EV Substance CodeSUB187493
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 2
    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 nameRadiprodil
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Granules for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRadiprodil
    D.3.9.1CAS number 496054-87-6
    D.3.9.2Current sponsor codeRadiprodil Form A
    D.3.9.4EV Substance CodeSUB187493
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    gain of function (GoF) variants in the GRIN 1, 2A, 2B or 2D genes
    varianti con guadagno di funzione (GoF) nei geni GRIN 1, 2A, 2B or 2D
    E.1.1.1Medical condition in easily understood language
    GRIN-related disorder
    Disturbo correlato a GRIN
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10064062
    E.1.2Term Neurodevelopmental disorder
    E.1.2System Organ Class 10037175 - Psychiatric 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 determine the safety and tolerability of multiple individually titrated doses of radiprodil as an add-on therapy to standard of care (SOC) in pediatric participants
    •To establish a safe and well tolerated dose after 8 weeks of continuous treatment
    •To determine the pharmacokinetics (PK) and plasma exposure of radiprodil
    • Determinare la sicurezza e la tollerabilità di dosi multiple titolate individualmente di radiprodil come terapia aggiuntiva allo standard di cura (SOC) nei partecipanti pediatrici
    • Stabilire una dose sicura e ben tollerata dopo 8 settimane di trattamento continuo
    • Determinare la farmacocinetica (PK) e l’esposizione plasmatica di radiprodil
    E.2.2Secondary objectives of the trial
    •To evaluate initial signs of efficacy on frequency and severity of epileptic seizures in those participants with seizures
    •To evaluate initial signs of efficacy of radiprodil on additional central nervous system (CNS) features including, behavior, motor symptoms, sleep, and quality of life
    •To determine the PK and the plasma exposure of radiprodil major metabolites obtained at different doses
    • Valutare i segni iniziali di efficacia su frequenza e gravità delle crisi epilettiche nei partecipanti che manifestano crisi epilettiche
    • Valutare i segni iniziali dell’efficacia di radiprodil su altri aspetti del sistema nervoso centrale (SNC), inclusi comportamento, sintomi motori, sonno e qualità della vita
    • Determinare la PK e l’esposizione plasmatica dei principali metaboliti di radiprodil ottenuti a dosaggi differenti
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Pediatric participants aged =6 months to =12 years with GRIN 1, 2A, 2B, or 2D gene variants known to result in GoF of the NMDA receptor.
    2.Participant to be enrolled in the first cohort experiences the following:
    a)At least 1 observable motor seizure per week and =4 observable motor seizures (generalized or focal) during the prospective 4 week Observation Period.
    b)Has failed to obtain adequate seizure control with at least 2 ASMs used at appropriate dose and duration with assured medication adherence (if applicable).
    3.Participant to be enrolled in the second cohort experiences the following:
    a)Significant behavioral and/or motor symptoms based on caregiver report with a CGI-S score =4 at the Screening Visit and Day -1 of Visit T1.
    4.Current antiseizure therapies should be maintained stable throughout the whole study duration, and nonpharmacological treatments such as ketogenic diet should be kept as stable as possible during the participation in the study.
    5.Participant’s caregivers have signed informed consent and participant has signed assent (if applicable).
    6.Participant’s caregivers are willing and able to complete entries in the eDiary on a daily basis.
    7.Participant is 1 of the following:
    a.Not of childbearing potential (premenarchal or male/not in possession of a uterus).
    b.If of childbearing potential, is nonpregnant (negative serum pregnancy test results at Screening), nonlactating, and practicing 1 of the following medically acceptable methods of birth control:
    •Abstinence as a lifestyle choice.
    •Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the participant’s usual menstrual cycle period) before IP administration.
    •Intrauterine device.
    c.If male, is willing to use a highly effective method of contraception throughout the study period.
    1. Partecipanti pediatrici di età compresa tra = 6 mesi e < 12 anni con le varianti del gene 1, 2A,
    2B, or 2D note per causare il GoF del recettore NMDA.
    2. Il partecipante da arruolare nella prima coorte presenta quanto segue:
    a) Almeno 1 crisi epilettica motoria a settimana osservabile e =4 crisi epilettiche motorie (generalizzate o focali) osservabili nelle 4 settimane del Periodo di osservazione prospettico.
    b) Mancato controllo adeguato delle crisi epilettiche con almeno 2 farmaci antiepilettici usati alla dose e per la durata appropriati con aderenza al farmaco verificata(se pertinente).
    3. Il partecipante da arruolare nella seconda coorte presenta quanto segue:
    a) Sintomi comportamentali e/o motori significativi in base al resoconto del caregiver con un punteggio CGI-S =4 alla Visita di screening e al Giorno -1 della Visita T1.
    4. Le terapie antiepilettiche correnti devono essere mantenute stabili per tutta la durata dello studio e i trattamenti non farmacologici come la dieta chetogenica devono essere mantenuti più stabili possibile durante la partecipazione allo studio.
    5. I caregiver del partecipante hanno firmato il consenso informato e il partecipante ha firmato l’assenso (se pertinente).
    6. I caregiver del partecipante sono disposti e in grado di completare quotidianamente i dati nell’eDiary.
    7. Il partecipante è uno dei seguenti:
    a. Non in età fertile (pre-menarca o maschio/senza utero).
    b. Se in età fertile, non è in gravidanza (test di gravidanza sul siero con risultato negativo allo Screening), non in allattamento e utilizza 1 dei seguenti metodi contraccettivi accettabili dal punto di vista medico:
    • Astinenza come stile di vita.
    • Metodi contraccettivi ormonali, come i contraccettivi orali, impiantabili, iniettabili o transdermici per almeno 1 ciclo completo (in base al ciclo mestruale usuale della partecipante) prima della somministrazione dell’IP.
    • Dispositivo intrauterino.
    c. Se maschio, è disposto a usare un metodo contraccettivo altamente efficace per tutto il periodo di studio.
    E.4Principal exclusion criteria
    1.Participant with any other clinically relevant medical, neurologic, or psychiatric condition and/or behavioral disorder unrelated to GRIN-related disorder that would preclude or jeopardize participant’s safe participation or the conduct of the study according to the judgement of the investigator.
    2.Participant with any clinically significant laboratory or ECG abnormalities.
    3. Participant has severe hepatic dysfunction (Child-Pugh grade C).
    4.Participant has a history of brain surgery for epilepsy or any other reason.
    5.Participant with any contraindications to radiprodil or with known hypersensitivity to the active substance or the excipients or other chemically closely related substances.
    6.Participant receiving treatment with contraindicated concomitant drugs such as agonists or antagonists of the glutamate receptor, including but not limited to felbamate, memantine, and perampanel.
    7.Participant is on treatment with hormonal therapy such as adrenocorticotrophic hormone or prednisolone.
    8.Participant has participated in any other investigational clinical study within 3 months of Screening.
    9.Participant has previously been enrolled in the current study
    1. Partecipante con qualsiasi altra condizione medica, neurologica o psichiatrica e/o disturbo comportamentale clinicamente rilevante non correlato a GRIN che possa precludere o compromettere la partecipazione in sicurezza del partecipante o la conduzione dello studio, a giudizio dello sperimentatore.
    2. Partecipante con anomalie di laboratorio o all'ECG clinicamente significative.
    3. Partecipante con grave disfunzione epatica (grado C secondo la classificazione Child-Pugh)
    4. Partecipante con un’anamnesi di chirurgia cerebrale per l’epilessia o qualsiasi altra ragione.
    5. Partecipante con qualsiasi controindicazione a radiprodil o con ipersensibilità nota al principio attivo o agli eccipienti o ad altre sostanze chimicamente molto simili.
    6. Partecipante che riceve il trattamento con farmaci concomitanti controindicati come gli agonisti o gli antagonisti del recettore del glutammato, compresi, ma non solo, felbamato, memantina e perampanel.
    7. Partecipante in trattamento con terapia ormonale, come ad esempio l’ormone adrenocorticotropo o prednisolone.
    8. Il partecipante ha partecipato a un altro studio clinico sperimentale nei 3 mesi anteriori dallo Screening.
    9. Il partecipante è stato arruolato in precedenza in questo studio.
    E.5 End points
    E.5.1Primary end point(s)
    •Adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs) (frequency, type, severity, and duration)
    •Changes in vital signs
    •Physical examination findings
    •12-lead electrocardiogram (ECG) findings
    •Clinically significant changes in laboratory parameters
    •Emergence of new seizure types
    •Occurrence of suicidal ideation or behavior
    •Tolerable dose that delivers the highest expected estimated receptor occupancy (RO) of approximately 80%
    •Plasma concentrations of radiprodil
    • Eventi avversi (AE), eventi avversi gravi (SAE) e reazioni avverse al farmaco (ADR) (frequenza, tipo, gravità e durata)
    • Variazione dei segni vitali
    • Risultati dell’esame obiettivo
    • Risultati dell’elettrocardiogramma a 12 derivazioni (ECG)
    • Cambiamenti clinicamente significativi nei parametri di laboratorio
    • Insorgenza di nuovi tipi di crisi epilettiche
    • Presenza di pensieri o comportamenti suicidi
    • Dose tollerabile che eroga l’occupazione recettoriale (RO) massima prevista stimata di circa 80%
    • Concentrazioni plasmatiche di radiprodil
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to the Schedule of Events presented in the study protocol (table 2-1, page 15-16)
    Fare riferimento al Programma degli Eventi presentato nel protocollo di studio (tabella 2-1, pagina 15-16)
    E.5.2Secondary end point(s)
    •Change from Baseline to end of treatment in seizure frequency from daily seizure electronic diary (eDiary)
    •Percent change from Baseline to end of treatment in video electroencephalogram (V EEG) seizure burden (e.g., seizure type, severity, and frequency recorded during V EEGs)
    •Seizure free days and longest period with no seizures
    •Change from Baseline to end of treatment in behavioral features as measured by the aberrant behavior checklist-community (ABC-C), as well as other disorder features as measured by gross motor function measure (GMFM), sleep disturbance scale for children (SDSC), quality of life (Pediatric Quality of Life Inventory [PedsQL]), Caregiver Burden Inventory (CBI),and global impression (Caregiver Global Impression of Change [CaGI-C]), and Clinical Global Impression of Change [CGI-C] scales)
    •Plasma concentrations of the 2 major metabolites of radiprodil
    • Variazioni nella frequenza delle crisi epilettiche dal basale alla fine del trattamento rilevate nel diario elettronico (eDiary)
    • Variazione percentuale rilevata nel video-elettroencefalogramma (V EEG) dell’impatto della crisi epilettica (ad es. tipo, gravità e frequenza delle crisi epilettiche registrate durante i V EEG), dal basale alla fine del trattamento
    • Giorni in cui non si verificano crisi epilettiche e il periodo più lungo senza crisi epilettiche
    • Variazioni dal basale alla fine del trattamento nelle caratteristiche comportamentali misurate mediante la Aberrant behavior checklist-community (ABC-C), oltre ad altre caratteristiche patologiche misurate mediante Gross motor function measure (GMFM), Sleep disturbance scale for children (SDSC), qualità della vita (Pediatric Quality of Life Inventory [PedsQL]), Caregiver Burden Inventory (CBI) e impressioni globali (scale Caregiver Global Impression of Change [CaGI C]) e Clinical Global Impression of Change [CGI-C])
    • Concentrazioni plasmatiche dei 2 principali metaboliti di radiprodil
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to the Schedule of Events presented in the study protocol (table 2-1, page 15-16)
    Fare riferimento al Programma degli Eventi presentato nel protocollo di studio (tabella 2-1, pagina 15-16)
    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 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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1B study
    Studio di Fase 1B
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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.8.2.4Number of treatment arms in the trial1
    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 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
    United States
    Netherlands
    Spain
    Germany
    Italy
    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
    LVLS
    LVLS
    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 months9
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days15
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 4
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 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
    children with neurodevelopmental disorders
    bambini con disturbi del neurosviluppo
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 24
    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)
    Participants who are considered eligible at the end of the Maintenance Period will be given the option to continue radiprodil treatment by participating in a follow-up extension study, under a separate protocol
    I partecipanti considerati idonei al termine del periodo di mantenimento avranno la possibilità di continuare il trattamento con radiprodil partecipando a uno studio di estensione di follow-up, nell'ambito di un protocollo separato
    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 Decision2023-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-22
    P. End of Trial
    P.End of Trial StatusOngoing
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