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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-001071-20
    Sponsor's Protocol Code Number:NSC18001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-07-17
    Trial results View 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 number2018-001071-20
    A.3Full title of the trial
    A 10-day prospective, single-center, double-blind, placebo-controlled, randomized study to evaluate safety, tolerability and pharmacokinetics of 600 mg b.i.d. oral doses of LM11A-31-BHS in healthy elderly volunteers
    Ensayo prospectivo, unicéntrico, doble ciego, controlado con placebo y aleatorizado para estudiar la seguridad, tolerabilidad y farmacocinética de dos dosis orales diarias de 600 mg de LM11A‐31‐BHS en sujetos sanos adultos de tercera edad.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study performed at 1 site with a treatment duration of 10 days 2 treatment arms (1 dosages LM11A-31-BHS and 1 placebo), which are randomly distributed in a double-blind manner (neither physician nor patient will know which treatment arm) between the patients to evaluate safety, tolerability and the distribution of the study drug in the blood and the spinal fluid
    Un estudio clínico realizado en un unico centro con una duración de tratamiento de 10 días 2 brazos de tratamiento (1 dosis de LM11A-31-BHS y 1 placebo), que se distribuyen aleatoriamente de forma doble ciego (ni el médico ni el paciente sabrán qué brazo de tratamiento ) entre los pacientes para evaluar la seguridad, la tolerabilidad y la distribución del fármaco del estudio en la sangre y el fluido espinal
    A.4.1Sponsor's protocol code numberNSC18001
    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 SponsorPharmatrophix 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 supportPharmatrophix Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeuroScios GmbH
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressWillersdorferstrasse 7
    B.5.3.2Town/ citySt. Radegund
    B.5.3.3Post code8061
    B.5.3.4CountryAustria
    B.5.4Telephone number004331324044412
    B.5.5Fax number004331324044420
    B.5.6E-mailnhelmberg@neuroscios.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 nameLM11A-31-BHS
    D.3.2Product code LM11A-31-BHS
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLM11A-31-BHS
    D.3.9.2Current sponsor codeLM11A-31-BHS
    D.3.9.3Other descriptive nameLM11A-31-BHS
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Mild to moderate Alzheimer's disease
    Enfermedad de Alzheimer leve a moderada
    E.1.1.1Medical condition in easily understood language
    Mild to moderate Alzheimer's disease
    Enfermedad de Alzheimer leve a moderada
    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 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066571
    E.1.2Term Progression of Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the safety and tolerability of 600mg bid of LM11A-31-BHS (free base) administered for a period of 10 days in comparison to placebo.
    Safety will be assessed through adverse event reporting, clinical laboratory, ECG and a standard range of patient physical evaluations.
    Investigar la seguridad y tolerabilidad de 600 mg b.i.d. de LM11A-31-BHS administradas por vía oral a voluntarios ancianos sanos durante un período de 10 días en comparación con placebo.
    E.2.2Secondary objectives of the trial
    To investigate the systemic pharmacokinetics of 600 mg b.i.d. doses of LM11A-31-BHS administered orally for a period of 10 days in healthy elderly volunteers.
    To evaluate cerebrospinal fluid (CSF) levels of LM11A-31-BHS under the conditions of this trial.
    Investigar la farmacocinética sistémica de 600 mg b.i.d. de LM11A-31-BHS administradas por vía oral durante un período de 10 días en voluntarios ancianos sanos.
    Evaluar los niveles de líquido cefalorraquídeo (LCR) de LM11A-31-BHS bajo las condiciones de este ensayo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women (non-childbearing potential)
    2. Age 60-85 years
    3. Formal education for eight or more years
    4. Volunteers living at home or nursing home setting without continuous nursing care
    5. General health status acceptable for a participation in a 10-day clinical trial
    6. Stable pharmacological treatment of any other chronic condition for at least one month prior to screening
    7. No regular intake of prohibited medications as noted in Section 6.8.
    8. Signed informed consent by volunteer prior to the initiation of any study specific procedure
    1. Hombres y mujeres (en edad no fértil).
    2. Edad entre 60-85 años.
    3. Educación formal de 8 años o más.
    4. Voluntarios que vivan en su hogar o en una residencia de ancianos sin atención de enfermería continua.
    5. Estado de salud en general aceptable para participar en un ensayo clínico de 10 días.
    6. Tratamiento farmacológico estable de cualquier otra afección crónica durante al menos un mes antes de la valoración general.
    7. Que no tome regularmente alguno de los medicamentos prohibidos como se indica en la Section 6.8.
    8. Que el Consentimiento Informado esté firmado por el voluntario antes del inicio de cualquier procedimiento especifico del ensayo.
    E.4Principal exclusion criteria
    1. Failure to perform screening or baseline examinations
    2. Hospitalization or change of chronic concomitant medication one month prior to screening or during screening period
    3. A current DSM-IV diagnosis of active major depression, schizophrenia or bipolar disorder
    4. Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, and which may bias the assessment of the clinical or mental status of the volunteer or put the volunteer at special risk, such as:
    • chronic liver disease, liver function test abnormalities or other signs of hepatic insufficiency (ALT, AST, Gamma GT, alkaline phosphatase > 2.5 ULN)
    • Respiratory insufficiency
    • Renal insufficiency (serum creatinine > 2mg/dL) or creatinine clearance ≤ 30 mL/min according to Cockcroft-Gault formula). In case of creatinine clearance ≤ 30mL/min, an alternative verification of the renal function must be completed using Cystatin C analysis. In case of normal level of Cystatin C, the volunteer can be included.
    • Heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within six months before screening)
    • Bradycardia (heart beat < 50/min.) or tachycardia (heart beat > 95/min.)
    • Hypertension (<180/95) or hypotension requiring treatment with more than three drugs
    • AV block (type II / Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcF-interval (males >450 and females >470 msec)
    • Uncontrolled diabetes defined by HbA1c >8.5
    • Malignant tumors within the last five years except skin malignancies (other than melanoma) or indolent prostate cancer
    • Metastases
    • Dysphagia, or any inability to swallow capsules, any known malabsorption or malassimilation syndromes and any gastrointestinal condition which might affect drug absorption, as judged by the investigator.
    5. Disability that may prevent the volunteer from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc.)
    6. Contraindication to lumbar puncture
    7. Women who are fertile and of childbearing potential
    8. Chronic daily drug intake of ≥ 14 days or expected for ≥ 14 days:
    • Benzodiazepines, neuroleptics or major sedatives
    • Antiepileptics
    • Centrally active anti-hypertensive drugs (clonidine, l-methyl DOPA, guanidine, guanfacine, etc.)
    • Opioid containing analgesics
    9. Suspected or known drug or alcohol abuse, i.e., more than approximately 60 g alcohol (approximately 1 liter of beer or 0.5 liter of wine) per day indicated by elevated MCV significantly above normal value at screening in the absence of other etiology.
    10. Suspected or known allergy to any components of the study treatments
    11. Enrollment in another investigational study or intake of investigational drug within the previous three months
    12. Any condition, which, in the opinion of the Investigator, makes the volunteer unsuitable for inclusion
    1. Fallo de screening
    2. Hospitalización o cambio de medicamentos concomitantes crónicos un mes antes o durante el periodo de screening.
    3. Un diagnostico DSM-IV actual de depresión mayor activa, esquizofrenia o trastorno bipolar
    4. Enfermedad clínicamente significativa, avanzada o inestable que pueda interferir con las evaluaciones de variables primarias o secundarias y que puede sesgar la evaluación del estado clínico o mental del voluntario o poner al voluntario en un riesgo especial, como por ejemplo:
    • Enfermedades hepáticas crónicas, anomalías en las pruebas de función hepática u otros signos de insuficiencia hepática (ALT, AST, Gamma GT, fosfatasa alcalina > 2.5 ULN)
    • Insuficiencia respiratoria.
    • Insuficiencia renal (creatinina sérica > 2mg/dL) o aclaramiento de creatinina ≤ 30 mL/min según la fórmula de Cockcroft-Gault ). En caso de aclaramiento de creatinina ≤ 30mL/min, se debe completar una verificación alternativa de la función renal mediante el análisis de Cistatina-C. En caso de niveles normales de Citastina-C el voluntario podrá ser incluido.
    • Enfermedad cardíaca (infarto de miocardio, angina inestable, insuficiencia cardíaca, miocardiopatía dentro de los seis primeros meses previos a la valoración)
    • Bradicardia (latido del corazón < 50/min.) o taquicardia (latido del Corazón > 95/min.)
    • Hipertensión (<180/95) o hipotensión que requiera tratamiento con medicación de más de 3 fármacos.
    • Bloqueo AV (tipo II / Mobitz II y tipo III), síndrome de QT congénito prolongado, disfunción del nódulo sinusal o intervalo QTcF (hombres >450 y mujeres >470 mseg)
    • Diabetes no controlada definida HbA1c >8.5
    • Tumores malignos en los últimos cinco años, excepto neoplasias malignas ( que no sean melanoma) o cáncer de próstata indolente.
    • Metastasis
    • Disfagia o cualquier incapacidad para tragar cápsulas, síndrome de mala absorción o mala asimilación conocidos y cualquier condición gastrointestinal que pueda afectar la absorción del fármaco, según lo juzgue el investigador
    5. Discapacidad que puede evitar que el voluntario complete todos los requisitos del estudio (por ejemplo, ceguera, sordera, dificultad grave de lenguaje, etc)
    6. Contraindicación para la punción lumbar
    7. Mujeres en edad fértil
    8. Ingesta diaria crónica de medicamento ≥ 14 días o esperada para ≥ 14 días:
    • Benzodiazepinas, neurolépticos o sedantes importantes
    • Antiepilépticos
    • Medicamentos antihipertensivos centralmente activos (clonidina, l-methyl DOPA, guanidina, guanfacina, etc.)
    • Analgésicos que contienen opiáceos.
    9. Sospecha o abuso de drogas o de alcohol, es decir, más de 60 g alcohol (aproximadamente 1 litro de cerveza o 0,5 litro de vino) por día indicado por MCV elevado significativamente por encima del valor normal en la detección en ausencia de otra etiología.
    10. Sospecha de alergia a cualquier componente de los tratamientos del estudio.
    11. Estar participando en otro estudio de investigación o haber participado en algún ensayo clínico con medicamentos en los tres meses previos.
    12. Cualquier condición que, en opinión del investigador, haga que el voluntario no sea apto para su inclusión.
    E.5 End points
    E.5.1Primary end point(s)
    All safety evaluations will be summarized as interval or categorical summaries as appropriate. The overall incidence of adverse events, together with the top three most frequently reported adverse events, will be analyzed using a binary logistic model to demonstrate differences between the treatment groups and placebo.
    The end points include alls Adverse events (AEs), Serious adverse events (SAEs), Clinical Diagnostics, Vital signs (blood pressure, heart rate, respiratory rate, body temperature), ECG, Laboratory assessment (hematology, biochemistry, serology and urinalysis)
    Todas las evaluaciones de seguridad se resumirán en resúmenes por intervalos o por categorías, según corresponda. La incidencia general de eventos adversos, junto con los tres eventos adversos notificados con mayor frecuencia, se analizará utilizando un modelo logístico binario para demostrar diferencias entre los grupos de tratamiento y el placebo.
    Los signos vitales (presión arterial, frecuencia cardiaca, frecuencia respiratoria, temperatura corporal), ECG, evaluación de laboratorio (hematología, bioquímica, serología y otros), efectos adversos graves (EAE) Análisis de orina)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Changes between baseline and end of study visit (10days)
    Cambios entre el inicio y el final de la visita de estudio (10 dias)
    E.5.2Secondary end point(s)
    PK measurements: • AUC(0-t), AUC(0-∞), Cmax, Tmax, t1/2, ClF, Vd Safety in blood and CSF
    Medidas PK: • AUC (0-t), AUC (0-∞), Cmax, Tmax, t1 / 2, ClF, Vd Seguridad en sangre y LCR
    E.5.2.1Timepoint(s) of evaluation of this end point
    Changes between baseline and end of study visit (10days)
    Cambios entre el inicio y el final de la visita de estudio (10 dias)
    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 No
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial months0
    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 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    N/A
    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 Decision2018-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
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