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    EudraCT Number:2020-004805-30
    Sponsor's Protocol Code Number:CLN-PXT3003-06
    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:2021-07-30
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-004805-30
    A.3Full title of the trial
    A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Assess the Efficacy, Safety, and Tolerability of PXT3003 in Charcot-Marie-Tooth type 1A (CMT1A)
    Estudio fase III, multicéntrico, aleatorizado, doble ciego y controlado con placebo, para evaluar la eficacia, seguridad y tolerabilidad de PXT3003 en la enfermedad de Charcot-Marie-Tooth tipo 1A (CMT1A)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 trial of PXT3003 in Charcot-Marie-Tooth (CMT) Type 1A patients
    Ensayo fase 3 de PXT3003 en pacientes con Charcot-Marie-Tooth (CMT) tipo 1A
    A.4.1Sponsor's protocol code numberCLN-PXT3003-06
    A.5.4Other Identifiers
    Name:IND numberNumber:122505
    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 SponsorPharnext SA
    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 supportPharnext SA
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharnext SA
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address46 rue Saint Lazare
    B.5.3.2Town/ cityParis
    B.5.3.3Post code7009
    B.5.4Telephone number+19178853598
    B.5.5Fax number+33141092231
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1260
    D.3 Description of the IMP
    D.3.1Product nameNA
    D.3.2Product code PXT3003
    D.3.4Pharmaceutical form Oral solution in sachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBACLOFEN
    D.3.9.1CAS number 1134-47-0
    D.3.9.3Other descriptive name(RS)-baclofen
    D.3.9.4EV Substance CodeSUB05667MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.6
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNALTREXONE
    D.3.9.1CAS number 16590-41-3
    D.3.9.3Other descriptive namenaltrexone hydrochloride
    D.3.9.4EV Substance CodeSUB09143MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.07
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSorbitol
    D.3.9.1CAS number 50-70-4
    D.3.9.3Other descriptive nameD-SORBITOL
    D.3.9.4EV Substance CodeSUB20837
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number21
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 solution in sachet
    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
    Charcot Marie Tooth Type 1A
    Charcot-Marie-Tooth tipo 1A
    E.1.1.1Medical condition in easily understood language
    Hereditary Motor and Sensory Neuropathy
    Neuropatía motora y sensorial hereditaria
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10008414
    E.1.2Term Charcot-Marie-Tooth disease
    E.1.2System Organ Class 100000004850
    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 efficacy of treatment with PXT3003 (a fixed-dose combination of (RS)-baclofen, naltrexone hydrochloride, and D-sorbitol) compared to placebo in subjects with CMT1A
    Evaluar la eficacia del tratamiento con PXT3003 (una asociación en dosis fijas de [RS]-baclofeno, naltrexona clorhidrato [HCl] y D-sorbitol) en comparación con un placebo en participantes con la enfermedad de Charcot-Marie-Tooth de tipo 1A (CMT1A)
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of PXT3003 treatment in subjects with CMT1A
    Evaluar la seguridad y la tolerabilidad del tratamiento con PXT3003 en participantes con CMT1A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male and non-pregnant female subjects, aged 16 to 65 years with a genetically proven diagnosis of CMT1A
    2) Able to provide written informed consent/assent and comply with study procedures
    3) Mild-to-moderate severity assessed by CMTNS-v2 score >2 and ≤18
    4) Muscle weakness in at least foot dorsiflexion on clinical assessment
    5) Ulnar nerve motor conduction time of at least 15m/s
    6) Stable dose of prescribed psychoactive drugs (e.g. antidepressants, stimulants, tranquilizers, anti-epileptics) for at least 4 weeks prior to randomization, which is not planned to be changed
    7) Stable dose of prescribed or ‘over-the-counter’ (OTC) analgesic medications (e.g. paracetamol/acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs]) for at least 2 weeks prior to randomization, which is not planned to be changed
    8) If female, subject must be: (a) Surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; or (b) Of childbearing potential and using a birth control method such as:
    • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
    o Oral
    o Intravaginal
    o Transdermal
    • Progestogen-only hormonal contraception associated with inhibition of ovulation:
    o Oral
    o Injectable
    o Implantable
    • Intrauterine device (IUD)
    • Intrauterine hormone-releasing system (IUS)
    • Bilateral tubal occlusion
    • Vasectomized partner
    • Sexual abstinence;
    or (c) Of non-childbearing potential (i.e., postmenopausal for at least 1 year)
    9) If male, the subject must have had a vasectomy or must use a reliable method of birth control with their partner or total abstinence from sexual intercourse. The subject must agree to continue using their selected method of birth control with their sexual partner during the study and for 120 days after study completion.
    1. Hombres y mujeres no embarazadas, de 16 a 65 años, con un diagnóstico genético confirmado de CMT1A.
    2. Capacidad para otorgar un consentimiento informado por escrito y cumplir los procedimientos del estudio.
    3. Enfermedad de gravedad leve a moderada determinada por una puntuación >2 y ≤18 en la CMTNS-V2.
    4. Debilidad muscular al menos en la dorsiflexión del pie en la exploración física.
    5. Tiempo de conducción del nervio cubital de al menos 15 m/s.
    6. Dosis estable de fármacos psicoactivos sujetos recetados (p. ej., antidepresivos, estimulantes, tranquilizantes o antiepilépticos) durante al menos las 4 semanas previas a la aleatorización y que no se prevé modificar.
    7. Dosis estable de medicamentos analgésicos sujetos a receta o de venta libre (p. ej., paracetamol o antiinflamatorios no esteroideos) durante al menos las 2 semanas previas a la aleatorización y que no se prevé modificar.
    8. En el caso de mujeres, la participante debe a) haberse sometido a una esterilización quirúrgica mediante una histerectomía, ooforectomía bilateral o ligadura de trompas bilateral; b) en caso de que pueda quedarse embarazada, utilizar un método anticonceptivo como:
    • Un anticonceptivo hormonal combinado (con estrógeno y progestágeno) que provoque la inhibición de la ovulación:
    o Oral
    o Intravaginal
    o Transdérmico
    • Anticonceptivo hormonal sólo con progestágeno que provoque la inhibición de la ovulación:
    o Oral
    o Inyectable
    o Implantable
    • Dispositivo intrauterino
    • Sistema intrauterino de liberación de hormonas
    • Oclusión tubárica bilateral
    • Pareja vasectomizada
    • Abstinencia sexual
    o; c) no tener capacidad fértil (es decir, mujeres postmenopáusicas desde hace al menos un año)
    9. En el caso de hombres, el participante debe haberse sometido a una vasectomía, utilizar un método anticonceptivo fiable con su pareja o abstenerse por completo de mantener relaciones sexuales. El participante debe comprometerse a seguir utilizando el método anticonceptivo que haya elegido con su pareja sexual durante el transcurso del estudio y durante los 120 días posteriores a la finalización del studio.
    E.4Principal exclusion criteria
    1) Subjects previously enrolled in any PXT3003 study
    2) Subjects living in the same household and enrolled in a PXT3003 study (due to potential lack of adequate storage for study material, risk of mixing treatments and potential unblinding)
    3) CMT of any subtype other than 1A
    4) ONLS score of 0
    5) Known clinically significant motor or sensory abnormalities secondary to a different neurological cause (e.g. diabetes, alcohol, vascular, autoimmune, neoplastic, neurodegenerative, HIV, etc.)
    6) Subjects who have had any surgery or have a concomitant disorder (e.g. severe arthrosis) that reduces the mobility of the ankle making it, in the opinion of the investigator, difficult to assess the efficacy of the treatment.
    7) Known peripheral neuropathy, myopathy, or neuromuscular disorder of any other kind
    8) Any other clinically significant and/or uncontrolled medical condition that, in the opinion of the investigator, could be a confound or may preclude successful participation or completion of the study
    9) Known hypersensitivity or intolerance to baclofen, naltrexone, or sorbitol
    10) Concomitant treatments including but not limited to baclofen, naltrexone, sorbitol (pharmaceutical form), opioids, and potentially neurotoxic drugs such as amiodarone, chloroquine, and chemotherapeutics capable of inducing peripheral neuropathy. Subjects able to stop these medications at least 2 weeks before randomization and for the study duration may be included
    11) History of porphyria
    12) Diagnosis or history of substance use disorder by DSM-V criteria within the past 12 months
    13) Medical or recreational use of marijuana in the 3 months prior to the Screening Visit
    14) Active suicidality (e.g. any suicide attempts within the past 12 months or any current suicide intent, including a plan, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) score of “YES” on questions 4 or 5; and/or based on clinical evaluation by the investigator)
    15) Currently active major depression, as determined by a Beck Depression Inventory (BDI-II) score ≥ 20
    16) Currently lactating, pregnant, or planning on becoming pregnant during the study
    17) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 2 times the upper limit of normal (ULN)
    18) Significant renal impairment as determined by Glomerular Filtration Rate (GFR) of less than 50 mL/min
    19) Subject has participated in an investigational drug or device study within 30 days prior to the Screening Visit or plans to participate in an investigational drug or device study during the course of this study
    20) Subject is a dependent and/or relative of the Sponsor or investigator.
    1. Participantes que ya hubiesen participado en cualquier otro estudio con PXT3003.
    2. Participantes que vivan en el mismo hogar y que se hayan inscrito en un estudio con PXT3003 (debido al posible almacenamiento inadecuado del material de estudio, el riesgo de mezclar los tratamientos y el posible desenmascaramiento).
    3. CMT de cualquier subtipo que no sea el 1A.
    4. Puntuación de 0 en la escala ONLS.
    5. Anomalías motoras o sensitivas conocidas de relevancia clínica secundarias a una causa neurológica distinta (p. ej., diabetes, alcohol, vascular, autoinmunitaria, neoplásica, neurodegenerativa, virus de la inmunodeficiencia humana, etc.).
    6. Participantes que se hayan sometido a una operación o que padezcan un trastorno concomitante (p. ej., artrosis grave) que reduzca la movilidad del tobillo y que, en opinión del investigador, dificultaría la evaluación de la eficacia del tratamiento.
    7. Neuropatía periférica, miopatía o cualquier otro tipo de trastorno neuromuscular conocido
    8. Cualquier otra afección médica de relevancia clínica o no controlada que, en opinión del investigador, podría ser un factor de confusión o impedir la participación o la finalización satisfactoria del estudio.
    9. Hipersensibilidad o intolerancia conocida al baclofeno, la naltrexona o el sorbitol.
    10. Tratamientos concomitantes que incluyan, entre otros, baclofeno, naltrexona, sorbitol (forma farmacéutica), opiáceos y fármacos potencialmente neurotóxicos, como la amiodarona, la cloroquina y los agentes quimioterapéuticos capaces de inducir una neuropatía periférica. Podrán incluirse participantes capaces de suspender los tratamientos con estos medicamentos al menos 2 semanas antes de la aleatorización y durante el transcurso del estudio.
    11. Antecedentes de porfiria.
    12. Diagnóstico o antecedentes de un trastorno por abuso de sustancias determinado conforme a los criterios de la quinta edición del Manual diagnóstico y estadístico de las enfermedades mentales en los 12 meses previos.
    13. Uso médico o recreativo de marihuana en los 3 meses anteriores a la visita de selección.
    14. Tendencias suicidas activas (p. ej., cualquier intento de suicidio en los últimos 12 meses o cualquier intento de suicidio actual, incluido un plan de suicidio, valorado en base a una respuesta de «SÍ» en las preguntas 4 o 5 de la C-SSRS o la evaluación clínica por el investigador).
    15. Depresión mayor activa en la actualidad determinada por una puntuación ≥20 en la segunda versión del Inventario de depresión de Beck (BDI-II, por sus siglas en inglés).
    16. Mujer en la lactancia, embarazada o que planea quedarse embarazada durante el transcurso del estudio.
    17. Niveles de alanina aminotransferasa o aspartato aminotransferasa superiores a 2 veces el límite superior de la normalidad.
    18. Deterioro renal significativo determinado por una tasa de filtración glomerular inferior a 50 ml/min.
    19. Paciente que ha participado en un estudio con fármacos o productos sanitarios en investigación en los 30 días previos a la visita de selección o que planea participar en un estudio con fármacos o productos sanitarios en investigación durante el transcurso de este estudio.
    20. Participante dependiente o familiar del promotor o el investigador principal.
    E.5 End points
    E.5.1Primary end point(s)
    The change in the modified Overall Neuropathy Limitation Scale (ONLS) between baseline and the Month 15 visit.
    Cambio en la puntuación obtenida en la escala ONLS modificada entre el inicio del estudio y la visita del mes 15.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 15 visit
    la visita del mes 15
    E.5.2Secondary end point(s)
    The change from baseline to month 15 in the following outcome measures in hierarchical order:
    1) 10-Meter Walk Test (10mWT)
    2) Quantified Muscular Testing (bilateral foot dorsiflexion dynamometry)
    3) Patient Global Impression of Severity (PGI-S)
    4) Patient Global Impression of Change (PGI-C)*
    5) Charcot-Marie-Tooth Neuropathy Score, version 2 (CMTNS-v2)
    6) Quantified Muscular Testing (hand grip)
    * Because the PGI-C is already a change assessment, the change from Baseline is not needed for this endpoint.
    El cambio entre el inicio del estudio y el mes 15 en los siguientes criterios de valoración enumerados en orden jerárquico:
    1. PM10
    2. Pruebas musculares cuantitativas (PMC) (dinamometría durante la dorsiflexión bilateral del pie)
    3. Escala de impresión general del paciente con respecto a la intensidad (PGI-S, por sus siglas en inglés)
    4. Escala de impresión general del paciente con respecto al cambio (PGI-C, por sus siglas en inglés)1
    5. CMTNS-V2
    6. PMC (agarre con la mano)
    *Dado que la escala PGI-C ya evalúa el cambio, no tiene que evaluarse el cambio desde el inicio del estudio para este criterio de valoración.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 15 visit
    la visita del mes 15
    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) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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 Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    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 - completion of the Month 15 Visit by the last subject
    finalización de la visita del mes 15 del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days28
    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: 56
    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. of subjects for this age range: 56
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 271
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 350
    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)
    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 Decision2021-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-13
    P. End of Trial
    P.End of Trial StatusOngoing
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