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    Summary
    EudraCT Number:2022-000317-14
    Sponsor's Protocol Code Number:RAD-GRIN-101
    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:2022-07-15
    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 number2022-000317-14
    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
    Estudio multicéntrico para evaluar la seguridad, tolerabilidad, farmacocinética y efecto sobre las convulsiones y síntomas comportamentales de múltiples dosis ajustadas individualmente de radiprodil en niños con trastorno asociado 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
    Estudio con radiprodil en niños con trastorno asociado a 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.3.4Pharmaceutical form Granules and solvent for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    Enteral use (Noncurrent)
    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 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.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.3.4Pharmaceutical form Granules and solvent for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    Enteral use (Noncurrent)
    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 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
    gain of function (GoF) variants in the GRIN2B gene
    ganancia de función (GDF) de los genes GRIN2B
    E.1.1.1Medical condition in easily understood language
    GRIN-related disorder
    trastorno asociado 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
    •Determinar la seguridad y la tolerabilidad de dosis múltiples ajustadas individualmente de radiprodil como tratamiento complementario a el tratamiento de referencia (TdR) en participantes pediátricos
    •Establecer una dosis segura y bien tolerada después de 8 semanas de tratamiento continuo
    •Determinar la farmacocinética (FC) y la exposición plasmática de 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
    •Evaluar los primeros signos de eficacia en la frecuencia y gravedad de los ataques epilépticos en los participantes con convulsiones
    •Evaluar los signos iniciales de eficacia del radiprodil en funciones adicionales del sistema nervioso central (SNC), como el comportamiento, los síntomas motores, el sueño y la calidad de vida
    •Determinar la FC y la exposición plasmática de los metabolitos principales del radiprodil obtenidos a diferentes dosis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Pediatric participants aged ≥6 months to ≤12 years with GRIN2B 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.Participantes pediátricos de ≥6 meses a ≤12 años con variantes del gen GRIN2B que se sabe que producen GDF del receptor NMDA.
    2.El participante a inscribirse en la primera cohorte experimenta lo siguiente:
    a)Al menos 1 convulsión motora observable por semana y ≥4 convulsiones motoras observables (generalizadas o focales) durante el período de observación prospectivo de 4 semanas.
    b)No ha logrado obtener un control adecuado de las convulsiones con al menos 2 medicamentos anticonvulsivos (MAC) utilizados a la dosis y durante el tiempo adecuados con el cumplimiento garantizado del tratamiento (si procede).
    3.El participante a inscribirse en la segunda cohorte experimenta lo siguiente:
    a)Síntomas conductuales o motores significativos sobre la base del informe del cuidador con una puntuación de ≥4 en la escala CGI-S en la visita de selección y el día -1 de la visita T1.
    4.Las terapias anticonvulsivas actuales deben mantenerse estables durante todo el estudio, y los tratamientos no farmacológicos como la dieta cetogénica deben mantenerse lo más estables posible durante la participación en el estudio.
    5.Los cuidadores del participante han firmado el consentimiento informado y el participante ha firmado el asentimiento (si corresponde).
    6.Los cuidadores del participante son capaces de incluir datos en el diario electrónico a diario y están dispuestos a hacerlo.
    7.El participante se corresponde con una de las siguientes opciones:
    a.No está en edad fértil (premenárquica o varón/no tiene útero).
    b.Si está en edad fértil, no está embarazada (resultados negativos de la prueba de embarazo en suero en la selección), no está en lactancia y practica uno de los siguientes métodos anticonceptivos médicamente aceptables:
    •Abstinencia como elección de estilo de vida.
    •Métodos hormonales, tales como anticonceptivos orales, implantables, inyectables o transdérmicos, durante un mínimo de 1 ciclo completo (de acuerdo con el ciclo menstrual habitual de la participante) antes de la administración del PEI.
    •Dispositivo intrauterino.
    c.Si es varón, está dispuesto a utilizar un método anticonceptivo muy eficaz durante todo el período del estudio.
    E.4Principal exclusion criteria
    1.Participant with any other clinically relevant medical, neurologic, or psychiatric condition and/or behavioral disorder unrelated to GRIN2B 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 receiving treatment with marijuana or tetrahydrocannabinol or derivatives (the use of Epidiolex® is permitted).
    9.Participant has participated in any other investigational clinical study within 3 months of Screening.
    10.Participant has previously been enrolled in the current study
    1.Participante con cualquier otra afección médica, neurológica o psiquiátrica clínicamente relevante o trastorno de conducta no relacionado con GRIN2B que impida o ponga en peligro la participación segura del participante o la realización del estudio según la opinión del investigador.
    2.Participante con cualquier anomalía clínicamente significativa en las pruebas de laboratorio o ECG.
    3.Participante que tiene disfunción hepática grave (clase C de Child-Pugh).
    4.Participante que tiene antecedentes de cirugía cerebral por epilepsia o cualquier otra razón.
    5.Participante con cualquier contraindicación a radiprodil o con hipersensibilidad conocida al principio activo o a los excipientes u otras sustancias químicas estrechamente relacionadas.
    6.Participante que recibe tratamiento con medicamentos concomitantes contraindicados, como agonistas o antagonistas del receptor de glutamato, incluidos, entre otros, felbamato, memantina y perampanel.
    7.Participante que está en tratamiento con hormonoterapia, tal como la hormona adrenocorticotrópica o la prednisolona.
    8.Participante que recibe tratamiento con marihuana o tetrahidrocannabinol o derivados (se permite el uso de Epidiolex®).
    9.Participante que ha participado en cualquier otro estudio clínico de investigación en los 3 meses previos a la selección.
    10.Participante que ha estado inscrito anteriormente en el estudio actual.
    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
    •Acontecimientos adversos (AA), acontecimientos adversos graves (AAG) y reacciones adversas a medicamentos (RAM) (frecuencia, tipo, gravedad y duración)
    •Cambios en las constantes vitales
    •Hallazgos de la exploración física
    •Hallazgos del electrocardiograma (ECG) de 12 derivaciones
    •Cambios clínicamente significativos en los parámetros de laboratorio
    •Aparición de nuevos tipos de convulsiones
    •Aparición de ideación o conducta suicida
    •Dosis tolerable que proporciona la mayor ocupación estimada de receptores (OR) de aproximadamente el 80 %
    •Concentraciones plasmáticas de 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)
    Consulte el calendario de acontecimeintos presentado en el protocolo del estudio (tabla 2-1, página 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 (ABCC), 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
    •Cambio entre inicio y final del tratamiento en la frecuencia de las convulsiones en el diario electrónico de convulsiones (diario electrónico)
    •Cambio porcentual entre inicio y final del tratamiento en la carga convulsiva por vídeoelectroencefalograma (Vídeo-EEG) (p. ej., tipo, gravedad y frecuencia de las convulsiones registrados durante los vídeo-EEG)
    •Días sin convulsiones y período más largo sin convulsiones
    •Cambio entre inicio y final del tratamiento en las características conductuales medidas en la escala de comportamiento Aberrant Behavior Checklist-Community (ABCC), así como otras características del trastorno medidas en las escalas de medida de la función motora gruesa (GMFM), trastornos del sueño para niños (SDSC), calidad de vida (Cuestionario de calidad de vida pediátrica [PedsQL]), Evaluación de carga del cuidador (CBI) y la impresión global (Impresión global del cambio por parte del cuidador [CaGI C]), e Impresión clínica global del cambio [CGI-C])
    •Concentraciones plasmáticas de los 2 metabolitos principales del 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)
    Consulte el calendario de acontecimeintos presentado en el protocolo del estudio (tabla 2-1, página 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
    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 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.8.2.4Number 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 No
    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
    Última visita último paciente
    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 months9
    E.8.9.1In the Member State concerned days15
    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.1.1Number of subjects for this age range: 12
    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: 2
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    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
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6
    F.4.2.2In the whole clinical trial 12
    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
    A los participantes que se consideren aptos al final del periodo de mantenimiento se les dará la opción de continuar el tratamiento con radiprodil participando en un estudio de extensión de seguimiento, bajo un protocolo separado
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-17
    P. End of Trial
    P.End of Trial StatusOngoing
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