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    Summary
    EudraCT Number:2018-004792-13
    Sponsor's Protocol Code Number:NFX88-2A-2018
    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:2019-04-12
    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 number2018-004792-13
    A.3Full title of the trial
    A randomized, double-blind, placebo controlled, parallel group,
    multicentric, phase IIa clinical trial to evaluate the safety,
    tolerability and therapeutic efficacy of daily oral treatment with
    NFX88 on neuropathic pain in patients with spinal cord injury.
    Ensayo clínico en fase IIa, aleatorizado, doble ciego, controlado con
    placebo, de grupos en paralelo y multicéntrico, para evaluar la
    seguridad, la tolerabilidad y la eficacia terapéutica del tratamiento
    diario oral con NFX88 sobre el dolor neuropático en pacientes con
    lesión de médula espinal.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the safety, tolerability and therapeutic efficacy of daily oral treatment with NFX88 in patients with neuropathic pain after spinal cord injury.
    Ensayo clínico para evaluar la seguridad, la tolerabilidad y la eficacia terapéutica del tratamiento diario oral de NFX88 en pacientes con dolor neuropático tras lesión de médula espinal.
    A.4.1Sponsor's protocol code numberNFX88-2A-2018
    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 SponsorNeurofix S.L.
    B.1.3.4CountrySpain
    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 supportNeurofix S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQualitecFarma S.L.
    B.5.2Functional name of contact pointÓscar Mesa del Castillo
    B.5.3 Address:
    B.5.3.1Street AddressMusgo 2, Edificio Europa II, 2ª planta, oficina H.
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28023
    B.5.3.4CountrySpain
    B.5.4Telephone number0034913728399400
    B.5.6E-mailclinical.trials@qualitecfarma.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 name2-OHOA
    D.3.2Product code NFX88
    D.3.4Pharmaceutical form Coated tablet
    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 INNNFX88
    D.3.9.2Current sponsor codeNFX88
    D.3.9.3Other descriptive name2-HYDROXYOLEIC ACID
    D.3.9.4EV Substance CodeSUB195753
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number350
    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 placeboCoated tablet
    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
    Neuropathic pain in spinal cord injury patients.
    Dolor neuropático en pacientes con lesión de médula espinal.
    E.1.1.1Medical condition in easily understood language
    Neuropathic pain in spinal cord injury patients.
    Dolor neuropático en pacientes con lesión de médula espinal.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the safety and tolerability of NFX88 in spinal cord injury patients with neuropathic pain over ninety-day treatment period.
    El objetivo principal del ensayo será evaluar la seguridad y la tolerabilidad de NFX88 en pacientes con lesión de médula espinal y dolor neuropático durante noventa días.
    E.2.2Secondary objectives of the trial
    The secondary objective is to explore the preliminary therapeutic efficacy associated with NFX88 through the analysis of validated measurement scales: VAS, PD-Q and PGIC.
    En el ensayo se explorará también la eficacia terapéutica preliminar de NFX88 mediante el análisis de escalas de medición validadas (EVA, PD-Q, PGIC).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients eligible for enrolment in the study must meet all the following inclusion criteria:
    1. Able and willing to provide written informed consent.
    2. Male or Female 18 to 65 years of age.
    3. Traumatic complete or incomplete spinal cord injury with C4-T12 level and more than three months since injury.
    4. Diagnosed of neuropathic pain with an average pain score = 4 measured using the VAS scale during the last week.
    5. Stable treatment, for at least 1 month, with pregabalin 150-300 mg/day, that should be maintained at the same dose for 90 days until the end of the study treatment.
    6. Normotensive patients defined as patients with blood pressure values between 90-160 for systolic pressure and 50-100 for diastolic pressure.
    7. Patients who have been treated with stable doses of neuroactive drugs (antidepressants, anticonvulsants, antispastic and similar medicines) at least during the last month, can also be recruited.
    8. Availability for the entire study period, absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; willingness to adhere to the protocol requirements, ability to cooperate adequately, to understand and follow the instructions of the physician or designee.
    9. Women who are not postmenopausal (at least 12 months) or surgically sterile must have a negative pregnancy test at screening and at the end of study and either abstain from sexual intercourse or use a highly effective method of birth control for the duration of the study and after 12 weeks after the last dose of study drug.
    10. For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm for the duration of the study and after 12 weeks from the last dose of study drug.
    Los pacientes elegibles para ser incluidos en el estudio deben
    cumplir todos los criterios de inclusión siguientes:
    1. Ser capaces y estar dispuestos a dar su consentimiento
    informado por escrito.
    2. Varones o mujeres de una edad comprendida entre 18 y 65
    años.
    3. Lesión de médula espinal traumática, completa o incompleta,
    con afectación de C4-T12 y más de tres meses transcurridos
    desde la lesión.
    4. Diagnosticados de dolor neuropático y con una puntuación
    promedio de dolor = 4 en la EVA (Escala Visual Analógica)
    durante la última semana.
    5. Tratamiento estable durante un mínimo de 1 mes con
    pregabalina en dosis de 150-300 mg/día, que debe mantenerse a
    la misma dosis durante 90 días hasta el final del tratamiento del
    estudio.
    6. Pacientes normotensos, definidos como pacientes con valores de
    presión arterial sistólica de 90-160 y valores de presión diastólica
    de 50-115.
    7. También pueden incluirse pacientes que hayan sido tratados con
    dosis estables de fármacos neuroactivos (antidepresivos,
    anticonvulsivos, antiespásticos y medicamentos similares) al
    menos durante el último mes.
    8. Disponibilidad durante todo el periodo del estudio; ausencia de
    problemas intelectuales que puedan limitar la validez del
    consentimiento para participar en el estudio o el cumplimiento
    de los requisitos del protocolo; voluntad de adherirse a los
    requisitos del protocolo; capacidad de cooperar adecuadamente
    y de entender y seguir las instrucciones del médico o la persona
    designada.
    9. Las mujeres que no sean posmenopáusicas (al menos 12
    meses) o que no hayan sido esterilizadas quirúrgicamente
    deberán presentar una prueba de embarazo negativa en la
    selección y al final del estudio, y abstenerse de mantener
    relaciones sexuales o utilizar un método anticonceptivo
    extremadamente eficaz durante todo el estudio y las 12 semanas
    posteriores a la última dosis de fármaco del estudio.
    10. Los varones deberán comprometerse a mantener la abstinencia
    o a utilizar medidas anticonceptivas, y a no donar esperma
    durante todo el estudio y las 12 semanas posteriores a la última
    dosis de fármaco del estudio.
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria must NOT be enrolled in the study:
    1. Patients treated with opiates (major and minor) and cannabinoids (synthetic, natural or
    analogous).
    2. Patients with blood pressure higher than those accepted in the inclusion criteria.
    3. History of alcohol, drug abuse within 6 months prior to screening.
    4. Psychiatric patients or those with moderate or severe cognitive impairment.
    5. Patient who is pregnant or lactating.
    6. Patient who shows evidence of significant liver or kidney disease, or any other
    conditions known to interfere with the absorption, distribution, metabolism or
    excretion of drugs or known to potentiate or predispose to undesired effects.
    7. Patient who has clinically significant diseases and/or infections captured in the medical
    history or evidence of clinically significant findings on physical examination and/or
    clinically significant ordinary laboratory evaluations (haematology, biochemistry, and
    urinalysis) or ECG.
    8. Patient who is currently participating in another clinical trial of an investigational drug
    or medical device within 90 days prior to screening.
    9. Inability to comply with study protocol.
    10. Patient unable to swallow 12 1-gram tablets.
    11. History of cancer except local basal or squamous cell carcinoma of the skin that has
    been excised.
    NO deberán incluirse en el estudio los pacientes que cumplan
    cualquiera de los siguientes criterios:
    1. Pacientes tratados con opiáceos (mayores y menores) y
    cannabinoides (sintéticos, naturales o análogos).
    2. Pacientes con presión arterial superior a la aceptada en los criterios de inclusión.
    3. Antecedentes de abuso de alcohol o drogas en los 6 meses
    previos a la selección.
    4. Pacientes psiquiátricos o con deterioro cognitivo moderado o
    grave.
    5. Pacientes embarazadas o lactantes.
    6. Pacientes con signos de enfermedad hepática o renal
    significativa, o con cualquier otra afección que interfiera con la
    absorción, la distribución, el metabolismo o la excreción de
    fármacos, o que se sepa que potencia o predispone a efectos no
    deseados.
    7. Pacientes que tengan enfermedades y/o infecciones clínicamente
    significativas registradas en la historia clínica, o que presenten
    hallazgos clínicamente significativos en la exploración física y/o
    en las evaluaciones de laboratorio habituales (hematología,
    bioquímica y análisis de orina) o el ECG.
    8. Pacientes que participen actualmente en otro ensayo clínico de
    un fármaco en investigación o un dispositivo médico, o que lo
    hayan hecho en los 90 días previos a la selección.
    9. Incapacidad de cumplir con el protocolo del estudio.
    10. Pacientes incapaces de tragar comprimidos.
    11. Antecedentes de cáncer excepto si se trata de un carcinoma
    basocelular o espinocelular de piel que ya ha sido extirpado.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability of NFX88 administered for ninety days will be evaluated by assessing the number, severity, and type of Adverse Event, including changes in vital signs, safety laboratory values (haematology, clinical chemistry and urinalysis), ECGs, and MAS (Modified Ashworth Scale) (e.g. to monitor spasticity worsening) and ASIA (e.g. to monitor neurological worsening) scores.
    Non-worsening of spasticity and motor score will be obtaining as the non-increase of the scales values MAS and ASIA, respectively, from the beginning to the end of the treatment.
    La seguridad y la tolerabilidad del NFX88 administrado durante noventa días se evaluarán evaluando el número, la gravedad y el tipo de acontecimiento adverso, incluidos los cambios en los signos vitales, los valores de laboratorio de seguridad (hematología, química clínica y análisis de orina), los ECG y las puntuaciones de las escalas MAS (Escala de Ashworth modificada) (por ejemplo, para controlar el empeoramiento de la espasticidad) y ASIA (por ejemplo, para controlar el empeoramiento neurológico).
    El no empeoramiento de la espasticidad y la puntuación motora se obtendrán como el no aumento de los valores de las escalas MAS y ASIA, respectivamente, desde el principio hasta el final del tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety and tolerability of NFX88 administered for 3 months will be assessed by the number, severity, and type of Adverse Events, including changes in:
    - Vital signs at Screening Visit (SV), Visit 1 (V1), Visit 2 (V2), Visit 3 (V3), End of Treatment Visit (EoT) or Withdrawal Visit (WV) and Follow-up/End of Study Visit (FU/EoS).
    - ECG at SV, V2, V3, EoT or WV and FU/EoS.
    - Clinical laboratory parameters (haematology, clinical chemistry and urinalysis) at SV, V2, V3, EoT or WV and FU/EoS.
    - Effect of NFX88 on spasticity score as determined by MAS at SV, V1, V2, V3, EoT or WV and FU/EoS.
    - Effect of NFX88 on sensory and motor function by ASIA scale at SV, V1, V2, V3, EoT or WV and FU/EoS.
    La seguridad y tolerabilidad de NFX88 administrados durante 3 meses se evaluarán por el número, gravedad y tipo de acontecimiento adverso, incluidos los cambios en:
    - Signos vitales en la visita de selección (SV), visita 1 (V1), visita 2 (V2), visita 3 (V3), visita de finalización del tratamiento (EoT) o visita de retirada del estudio (WV) y visita de seguimiento/finalización del estudio (FU/EoS).
    - ECG en SV, V2, V3, EoT o WV y FU/EoS.
    - Parámetros de laboratorio clínico (hematología, química clínica y análisis de orina) en SV, V2, V3, EoT o WV y FU/EoS.
    - Efecto de NFX88 en la puntuación de espasticidad según lo determinado por MAS en SV, V1, V2, V3, EoT o WV y FU/EoS.
    - Efecto del NFX88 en la función sensorial y motora mediante la escala ASIA en SV, V1, V2, V3, EoT o WV y FU/EoS.
    E.5.2Secondary end point(s)
    Efficacy of NFX88 treatment compared to placebo in pain improvement will be measured as:
    - Reduction from Visit 1 (V1) to End of Treatment Visit (EoT) in pain intensity in the VAS (Visual analogue scale) scale.
    - Reduction from Screening Visit (SV) to EoT in the likelihood of neuropathic pain in PD-Q (Pain-DETECT Questionnaire) scale.
    - Global improvement at EoT in patient’s condition according to the PGIC (Patient Global Impression of Change) scale.
    La eficacia del tratamiento con NFX88 en comparación con el placebo en la mejora del dolor se medirá como:
    - Reducción desde la visita 1 (V1) hasta la visita al final del tratamiento (EoT) en la intensidad del dolor en la escala VAS (escala analógica visual).
    - Reducción desde la visita de selección (SV) hasta la EoT en la probabilidad de dolor neuropático en la escala PD-Q.
    - Mejora global en la EoT de la condición del paciente según la escala PGIC (Patient Global Impression of Change).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The effect of NFX88 in changes of neuropathic pain reduction scales will be obtained from:
    - VAS at Screening Visit (SV), Visit 1 (V1), Visit 2 (V2), Visit 3 (V3), End of Treatment Visit (EoT) or Withdrawal Visit (WV) and Follow-up/End of Study Visit (FU/EoS).
    - PD-Q at SV, V1, V2, V3, EoT or WV and FU/EoS.
    - PGIC at V3, EoT or WV.
    El efecto de NFX88 en los cambios de las escalas de reducción del dolor neuropático se obtendrá de:
    - VAS en la visita de selección (SV), visita 1 (V1), visita 2 (V2), visita 3 (V3), visita de fin de tratamiento (EoT) o visita de retirada (WV) y en la visita de seguimiento/de fin de estudio (FU/EoS).
    - PD-Q en SV, V1, V2, V3, EoT o WV y FU/EoS.
    - PGIC en V3, EoT o WV.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 trial4
    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 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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    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: 60
    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 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 state60
    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)
    Principal Investigator discretion.
    A criterio del Investigador Principal
    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 Decision2019-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-18
    P. End of Trial
    P.End of Trial StatusOngoing
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