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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43244   clinical trials with a EudraCT protocol, of which   7156   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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    EudraCT Number:2011-005377-23
    Sponsor's Protocol Code Number:SCI-GHD-201
    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:2012-05-21
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2011-005377-23
    A.3Full title of the trial
    A phase II, single-center, prospective, randomized, double-blind, parallel and placebo-controlled pilot clinical study to assess the efficacy and safety of NUTROPIN® in combination with intensive rehabilitation in adults with spinal cord injury (SCI) and growth hormone deficiency (GHD).
    Ensayo clínico piloto de fase II, unicéntrico, prospectivo, aleatorizado, doble ciego, paralelo y controlado con placebo para evaluar la eficacia y seguridad de NUTROPIN® en combinación con rehabilitación intensiva en adultos con lesión en la médula espinal (SCI) y deficiencia de la hormona de crecimiento (GHD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study for the assesment of the efficacy and safey of NUTROPIN® in patients with spinal cord injury (SCI) and growth hormone deficiency (GHD).
    Estudio para la evaluación de la eficacia y seguridad de NUTROPIN® en pacientes con lesión en la médula espinal (SCI) y deficiencia de la hormona de crecimiento (GHD)
    A.4.1Sponsor's protocol code numberSCI-GHD-201
    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 SponsorGuillem Cuatrecasas Cambra
    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 supportIpsen Pharma, S.A.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Step by Step
    B.5.2Functional name of contact pointJoan Romero Càlix
    B.5.3 Address:
    B.5.3.1Street AddressCarrer Dolors Aleu 19-21, 3° 3ª
    B.5.3.2Town/ cityL?Hospitalet de Llobregat
    B.5.3.3Post code08908
    B.5.4Telephone number34932231663
    B.5.5Fax number34932237321
    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. name NUTROPIN
    D. of the Marketing Authorisation holderIpsen Pharma
    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 nameNutropinAq 10 mg/2 ml (30 UI)
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSOMATROPIN
    D.3.9.1CAS number 12629-01-5
    D.3.9.4EV Substance CodeSUB10584MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number0.0125
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Spinal Cord Injury and Growth Hormone Deficiency
    Lesión medular espinal y deficiencia de la hormona de crecimiento
    E.1.1.1Medical condition in easily understood language
    Spinal Cord Injury and Growth Hormone Deficiency
    Lesión medular espinal y deficiencia de la hormona de crecimiento
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10041558
    E.1.2Term Spinal cord injury thoracic
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10041554
    E.1.2Term Spinal cord injury cervical
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy and safety of Nutropin® in combination with intensive rehabilitation compared to placebo with intensive rehabilitation in patients with Spinal Cord Injury
    Evaluar la eficacia y seguridad de Nutropin® asociado a rehabilitación intensiva comparado con placebo más rehabilitación intensiva en pacientes con lesión medular
    E.2.2Secondary objectives of the trial
    - to assess QoL and spasticity changes
    - to assess neurological motor and sensibility changes
    - to assess safety
    - evaluar los cambios en la QoL y en la espasticidad
    - evaluar los cambios neurológicos motores y los cambios en la sensibilidad
    - evaluar la seguridad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Men or women aged 18 to 50 years (inclusive)
    -Cervical or thoracic (dorsal) spine injuries (C5-T12)
    -Complete lesions (ASIA A) with SSEP and EMG evaluation
    -Stability of the recovery (at least 12 months since injury)
    -Maintenance of muscular structure (no more than 24 months since injury)
    -Partial (<10 ng/ml) or total (<5 ng/ml) GH deficiency (assessed by GH stimulation tests)
    -Signed informed consent
    -Hombres o mujeres entre 18 y 50 años de edad (inclusive)
    -Lesiones (C5-T12) cervicales o torácicas (dorsales)
    -Lesiones completas (ASIA A) con evaluaciones de SSEP y EMG
    -Estabilidad de la recuperación (al menos 12 meses desde la lesión)
    -Mantenimiento de la estructura muscular (no mayor a 24 meses desde la lesión)
    -Deficiencia parcial (<10 ng/ml) o total (<5 ng/ml) de la GH (hormona de crecimiento) (evaluado a través de pruebas de estimulación de la GH)
    - Firma del consentimiento informado
    E.4Principal exclusion criteria
    -Spinal cord injury of non-traumatic origin
    -Adverse effects or hypersensitivity to GH or its excipients
    -Lack of neurophysiological assessment/confirmation of SCI
    -Previous very intensive rehabilitation
    -Previous growth hormone therapy
    -Evidence of any active malignancy or cancer in the last 5 years
    -Acute illnesses at time of randomization
    - Pregnancy
    -Participation in another interventional study
    -Inability to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study
    -Lesión de la médula espinal de origen no traumático
    -Efectos adversos o hipersensibilidad conocida a la GH o sus excipientes
    - Falta de evaluación neurofisiológica/confirmación de SCI
    -Rehabilitación intensiva previa (la rehabilitación convencional no se considerará criterio de exclusión)
    -Terapia previa con hormona de crecimiento
    -Evidencia de neoplasia activa o cáncer en los últimos 5 años
    -Enfermedad grave al momento de la aleatorización
    -Participación en otro estudio no intervencional
    -Incapacidad para cumplir con los requerimientos del estudio o sujetos que, en la opinión del investigador, no deberían participar en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    Changes in Spinal Cord Independence Measure (SCIM) III score
    Cambios en el resultado de la escala Spinal Cord Independence Measure (SCIM) III
    E.5.1.1Timepoint(s) of evaluation of this end point
    SCIM III will be assesed 4 times in 6 months: at visit 1 (day1), visit 2(month 1), visit 3(month 3) and visit 4 (month 6)
    SCIM III se evaluará 4 veces en 6 meses: en la visita 1 (día 1), visita 2 (mes 1), visita 3 (mes 3) y visita 4 (mes 6)
    E.5.2Secondary end point(s)
    - Changes in quality of life: Nottingham Health Profile (NHP) score
    - Neurological motor changes: percentage of patients with selective muscle activity >1 spinal metamere below lesion.
    - Neurological profound and superficial sensory changes: percentage of patients with > 1 spinal metamere below lesion: Metamere neurological activity mapping (ASIA) at physical examination (Neurophysiology) confirmed by:
    a.Electromyogram with measurement of individualized motor units to measure efferent motoneurons activity (A? and C fibers).
    b.Somatosensory evoked potencials (SSEP) to measure direct posterior A? and A? fibers activity (Goll and Burdach posterior Fasciculae).
    -Changes in spasticity assessment: Modified Ashworth Score (MAS) (Rehabilitation)
    -Cambios en cuanto a la calidad de vida: resultados según el Perfil de Salud de Nottingham (NHP, Nottingham Health Profile)
    -Cambios motores neurológicos: porcentaje de pacientes con actividad muscular selectiva >1 metámera por debajo de la lesión medular
    -Cambios neurológicos en la sensibilidad superficial y profunda: porcentaje de pacientes con cambios en la sensibilidad superficial y profunda > 1 metámera por debajo de la lesión: mapeo de la actividad neurológica de la metámera (ASIA) durante el examen físico (neurofisiología) confirmado a través de:
    a.Electromiograma con medición de unidades motoras individuales para medir la actividad de la motoneurona eferente (fibras A? y C).
    b.Potenciales evocados somatosensitivos (SSEP) para medir la actividad de las fibras A? y A? posteriores directas (fascículos posteriores de Goll y Burdach).
    -Cambios en la evaluación de la espasticidad: escala de Ashworth Modificada (MAS) (Rehabilitación)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoint will be assesed during the study visits (Visit 0, 1, 2, 3 and 4)
    Los objetivos secundarios se evaluarán durante las visitas del estudio (visita 0, 1, 2, 3, y 4)
    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 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. 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 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 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
    The study ends with the last visit of the last patient participating in the trial.
    El estudio finaliza con la última visita del último paciente que participa en el ensayo.
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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: 20
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    Standard clinical practice
    Práctica clínica habitual
    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 Decision2012-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
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