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    Summary
    EudraCT Number:2014-003272-23
    Sponsor's Protocol Code Number:NUBE
    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:2014-09-09
    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 number2014-003272-23
    A.3Full title of the trial
    Prospective Pilot Study of the treatment of compression of median nerve neuropathy with Nucleo CMP Forte®.
    Estudio piloto prospectivo del tratamiento con Núcleo CMP forte en la neuropatia compresiva del nervio Mediano.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of Carpal tunnel syndrome symptoms with Nucleo CMP Forte
    Tratamiento de los síntomas del sindrome tunel carpiano con Núcleo CMP Forte.
    A.4.1Sponsor's protocol code numberNUBE
    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 SponsorDr. Jordi Montero Homs- Unidad de Neuromuscular- Servicio de Neurología- Hospital Universitario de Bellvitge
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPromotor
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitari de Bellvitge
    B.5.2Functional name of contact pointDr. Jordi Montero Homs
    B.5.3 Address:
    B.5.3.1Street AddressCalle Feixa Llarga, s/n
    B.5.3.2Town/ cityL'Hospitalet de Llobregat (Barcelona)
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.4Telephone number349326077112679
    B.5.5Fax number34932607882
    B.5.6E-mailjmonterohoms@bellvitgehospital.cat
    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 Yes
    D.2.1.1.1Trade name Núcleo CMP Forte ®
    D.2.1.1.2Name of the Marketing Authorisation holderFerrer Internacional s.a.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameNúcleo CMP Forte
    D.3.4Pharmaceutical form Capsule
    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 INNURIDINE MONOPHOSPHATE
    D.3.9.1CAS number 58-97-9
    D.3.9.3Other descriptive nameURIDINE MONOPHOSPHATE
    D.3.9.4EV Substance CodeSUB126222
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCYTIDINE 5'-MONOPHOSPHATE
    D.3.9.1CAS number 63-37-6
    D.3.9.3Other descriptive nameCYTIDINE 5'-MONOPHOSPHATE
    D.3.9.4EV Substance CodeSUB93372
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    Carpal Tunnel Syndrome (CTS)
    Síndrome del túnel carpiano (STC).
    E.1.1.1Medical condition in easily understood language
    Carpal Tunnel Syndrome: more frequently pathology due to chronic medium nerve compression.
    Síndrome del túnel carpiano (STC): patología más frecuente por compresión nerviosa crónica
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10052414
    E.1.2Term Unilateral carpal tunnel syndrome
    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 evaluate the treatment of symptoms with Nucleo CMP Forte in patients diagnosed with CTS, using pain escales and quantification of sensitive positive symptoms
    Evaluar la eficacia del tratamiento con Núcleo C.M.P. Forte en la sintomatología del paciente con STC. Para ello se utilizaran escalas de dolor y de cuantificación de síntomas sensitivos positivos.
    E.2.2Secondary objectives of the trial
    1) To evaluate the improvement of life quality measured by SF36 test.

    2) To evaluate the improvement of electrophysiologic parametes according to sensitive conduction in carpal tunnel, distal motor latency, as well as motor and sensory potential amplitude.

    3) To evaluate the safety of the treatment with CMP Forte in patients with pain due to CTS.
    1-Evaluar la mejora de la calidad de vida a través del test SF 36.

    2-Evaluar la mejora de los parámetros ectrofisiológicos a través de la velocidad de conducción sensitiva en canal del carpo, latencia motora distal, así como amplitud de potencial sensitivo y motor.

    3- Evaluar la seguridad del tratamiento CMP forte en el tratamiento del dolor en pacientes con STC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patients between 18 and 80 years old.

    2) Patients clinically and electrophysiological diagnosed with CTS, who won?t require a premature surgical procedure.

    3) Patients able to understand the study objective and able to give the Inform Consent.
    1. Pacientes de edad entre 18 años y 80 años.

    2. Pacientes con diagnostico clínico y electrofisiológico de STC en los que no se prevea tratamiento quirúrgico precoz.

    3. Pacientes con capacidad de comprender el objetivo del estudio y de dar el consentimiento informado.
    E.4Principal exclusion criteria
    1) Pregnant or breastfeeding woman.

    2) Patients with high probablility os not completing the study requirements according to the investigator criteria.

    3) Patients with dysphagia which won?t allow them to take the study medication.

    4) Patients diagnosed with neuropathy which is causing an axonal degeneration.

    5) Patients with a recent forearm trauma.

    6) Patients participating in antother Clinical Trial.
    1) Mujeres gestantes o lactantes.

    2) Pacientes que a criterio del investigador probablemente incumplan los requisitos del estudio.

    3) Pacientes con disfagia que impida la toma de la medicación de estudio.

    4) Pacientes con neuropatía de base que causa degeneración axonal.

    5) Pacientes con traumatismos recientes en antebrazo.

    6) Pacientes que están participando en otro ensayo clínico.
    E.5 End points
    E.5.1Primary end point(s)
    Pain intensity acoording visual analogical escale at 6 months of treatment and 30 days after finishing the last dose of study treatment.

    Positive sensitive symptomatolgy manifested as paresthesia and dysesthesia at 6 months of treatment according to the evaluation of Carpal Tunnel?s sign and Phalen?s sign.
    Intensidad del dolor según escala analógica visual a los 6 meses de tratamiento.

    Sintomatología sensitiva positiva en forma de parestesia y disestesia a los 6 meses de tratamiento evaluado según signo de Tinel y signo de Phalen en Medianos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 6 months of treatment and 30 days after completion of study treatment.
    Basal, 6 meses de tratamiento y 30 días a partir de la finalización del tratamiento de estudio.
    E.5.2Secondary end point(s)
    - Life quality at 6 months of treatment according to SF36 questionaire
    - Adverse events
    - Elecrophysiologic parameters: sensitive and motor medium nerve conduction. Segments stimulation. Evaluation of:
    -Amplitude; response produced by the stimulation of two points along the nerve. This response will depend on the number of nervous functional muscle fibers and the integrity of neuromuscular unions.
    - Latency: period of time of recording the estimulus
    - Nervous conduction velocity; stimulus transmission velocity on a specific nerve
    - Calidad de vida a los 6 meses del tratamiento según el cuestionario SF36.
    - Acontecimientos adversos
    - Parámetros del estudio electrofisiológico: Conducción nervio mediano sensitivo y motor. Estimulación realizada por segmentos. Valoración de:
    - Amplitud:
    Definición conceptual: Respuesta producida por la estimulación de dos puntos a lo largo del trayecto del nervio. Ésta dependerá del número de fibras nerviosas funcionales en el músculo, y de la integridad de la unión neuromuscular.
    - Latencia:
    Definición conceptual: Tiempo que tarda en registrarse el estímulo.
    - Velocidad de conducción nerviosa
    Definición conceptual: Velocidad a la que se trasmite el estímulo en un nervio determinado.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Especificados para cada objetivo secundario en la sección E.5.2.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Prospectivo
    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.8.3 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state50
    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)
    Ninguno
    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 Decision2014-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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