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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2016-001227-31
    Sponsor's Protocol Code Number:NISCI
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-06-06
    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 ConcernedGermany - PEI
    A.2EudraCT number2016-001227-31
    A.3Full title of the trial
    Antibodies against Nogo-A to enhance plasticity,
    regeneration and functional recovery after
    acute spinal cord injury
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Therapy to enhance plasticity, Regeneration and functional recovery after acute spinal cord injury
    A.4.1Sponsor's protocol code numberNISCI
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03935321
    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 SponsorUniversity Zurich, University Hospital Balgrist, Spinal Cord Injury Center
    B.1.3.4CountrySwitzerland
    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 supportEUROPEAN COMMISSION
    B.4.2CountryEuropean Union
    B.4.1Name of organisation providing supportNovartis Pharma
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportSwiss State Secretariat for Education
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportSchweizer Paraplegiker Stiftung
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportWings for Life Stiftung
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHeidelberg University Hospital
    B.5.2Functional name of contact pointSpinal Cord Injury Center
    B.5.3 Address:
    B.5.3.1Street AddressSchlierbacher Landstrasse 200a
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69118
    B.5.3.4CountryGermany
    B.5.4Telephone number+4962215626321
    B.5.5Fax number+4962215626345
    B.5.6E-mailnorbert.weidner@med.uni-heidelberg.de
    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 nameNG-101 / ATI355
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrathecal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.2Current sponsor codeNG-101 or ATI355
    D.3.9.3Other descriptive namehuman monoclonal antibody against the human Nogo-A protein
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number34
    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) 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 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 placeboConcentrate for solution for injection
    D.8.4Route of administration of the placeboIntrathecal 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
    E.1.1.1Medical condition in easily understood language
    Acute cervical spinal cord injury, patients who suffer from spinal cord injury within 4-28 days post-injury are eligible
    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 20.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10041552
    E.1.2Term Spinal cord injury
    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
    To evaluate efficacy of acute treatment (initiation of drug treatment within 4 - 28 days post-injury) with
    NG-101 by repeated intrathecal (i.t.) bolus injections on day 168.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of acute treatment (initiation of drug treatment
    within 4 - 28 days post--injury) with NG-101 by repeated intrathecal
    bolus injections (6 injections of 45 mg each over 4 weeks)
    - Adverse Events (Frequency, type, duration and intensity of AEs and
    SAEs)
    - Relationship of AE/SAE frequency and time and duration of study
    medication administration
    - Documented reasons for any unplanned study medication
    interruptions and/or withdrawal from the study
    - Vital signs (blood pressure, heart frequency, body temperature)
     -Muscle spasticity measured by the Modified Ashworth Scale
     - Effect on pain (neuropathic pain and non-neuropathic pain) assessed by SCI pain data set, allodynia questionnaire and SCIPI
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    3 Sub studies (work packages (WP)) according to the EU application (that are not relevant to laws regulating the use of medicinal products):
    -Biostatistics (sub study WP2)
    Objective: develop a statistical model for the conditional distribution
    of ordinal measurements in two-- armed randomized clinical trials.
    Based on this model, minimal clinically important differences shall be
    discussed, and methods for sample size estimation, statistical
    inference and subgroup analyses shall be developed. We plan to setup
    a statistical framework allowing future clinical trials using SCIM self
    care & mobility or UEMS as primary endpoints to be planned and
    analyzed with procedures taking the specific properties of these
    endpoints into account. Results shall be used to improve the power to
    discern treatment effects in future studies.
    -Proteomics analysis (sub study WP3)
    Important part of the current trial is the collection of high quality
    biological samples (Serum derived from blood samples and CSF
    collected during diagnostic and therapeutic interventions, respectively)
    of patients suffering from acute SCI. Serum and CSF samples obtained
    in the course of the study will undergo proteomics analyses in order to
    identify proteomics based biomarkers to enable or support prognosis
    and outcome of the patients. Afterwards, a systematic categorization of
    the proteomes will be performed with comprehensive bioinformatic tools.
    -Neuroimaging (sub study WP4)
    Baseline MRI data acquired at the cervical level and brain will be used
    to characterize the extent of the lesion and the subsequent de- and
    regenerative processes occuring remote from the cervical cord injury
    both treatment groups. For the longitudinal data acquired at three
    distinct time points (0, 3, and 6 months), routine postprocessing
    pipelines will be applied to assess differences between the rates of
    change of neurodegeneration between both groups and explore
    possible treatment effects.
    Specifically, these quantitative images will provide information on the
    spontaneous and potentially treatment altered rates of changes of
    atrophy (volumetry), de- and remyelination and iron accumulation in
    both groups.

    These sub-studies are included in the main protocol.
    E.3Principal inclusion criteria
    1. Male or female, 18 through 70 years of age
    2. Acute cervical spinal cord injury (SCI) (Neurological level of injury
    C1 ≤ lesion ≤ C8) with confirmed classification of ASIA impairment
    scale (AIS) A-D at screening and predicted upper
    extremities motor score (UEMS) recovery of less than 41/50
    (according to the URP prediction model)
    3. 4-28 days post-injury (i.e. initiation of bolus injection within 4-28
    days post-injury)
    4. Tetraplegic patients who are allowed to start treatment are those
    who either do not require mechanical ventilation or who do not
    completely depend on mechanical ventilation but show some
    degree of spontaneous ventilation. Only those modes of ventilation
    where the patient show active initiation of breathing are allowed
    (e.g. continuous positive airway pressure (CPAP))
    5. Hemodynamically and clinically stable according to the acute SCI
    condition at baseline
    6. For patients of childbearing potential , use of reliable means of contraception
    7. Written informed consent by patient before any study assessment
    is performed. If the patient is only able to consent orally a witness
    signs and confirms the patient’s consent,
    8. Cooperation and willingness to complete all aspects of the study
    9. Ability of subject to understand character and individual
    consequences of the study
    E.4Principal exclusion criteria
    1. Complete anatomical transection confirmed by magnetic resonance imaging (MRI).
    2. Trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds.
    3. Multiple levels of clinically relevant spinal cord lesions.
    4. Major brachial or lumbar plexus damage/trauma.
    5. Significant head trauma (e.g. cortical damage/lesion), or other injury that was, in the opinion of the investigator, sufficient to interfere with the assessment of the spinal cord function or otherwise compromise the validity of the patient's data.
    6. Other significant pre-existing or current severe systemic disease such as lung, liver (exception: history of uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency (including anamnestic known HIV) or kidney disease; or active malignancy or any other condition as determined by history or laboratory investigation that could cause a neurological deficit including syphilis, myelopathy, clinically relevant polyneuropathy, etc.
    7. History of or an acute episode of Guillain-Barre syndrome.
    8. History of recent (6 months) meningitis or meningoencephalitis.
    9. History of refractory epilepsy.
    10. Patients with uncontrolled bleeding diathesis and/or who require uninterrupted concomitant therapeutic anticoagulation (e.g. phenoprocoumon (Marcumar®), heparin/heparinoids and new oral anticoagulants) at a higher dose than for the prophylaxis of venous thromboembolism
    11. Presence of any unstable medical or psychiatric condition (defined by the Diagnostic and Statistical Manual of Mental Disorders, Edition 4 (DSM-IV)) that could reasonably have been expected tosubject the patient to unwarranted risk from participation in the study or result in a significant deterioration of the patient's clinical course.
    12. Drug dependence (as defined by DSM-IV) any time during the 6 month’s preceding study entry.
    13. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL).
    14. History of a life-threatening allergic or immune mediated reaction.
    15. Patients with the presence of infection around the location where the spinal needle insertions are planned for applying the intrathecal injections.
    16. Inability to communicate effectively with the neurological examiner such that the validity of the patient's data could be compromised.
    17. Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
    18. Patients who are unconscious, including those patients who are unconscious due to medication causing marked sedation.
    19. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure.
    E.5 End points
    E.5.1Primary end point(s)
    Upper extremity motor scores (UEMS) according to the International
    Standards for the Neurological Classification of Spinal Cord Injury
    (ISNCSCI)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy endpoint (UEMS recovery) will be analysed by the comparison of the mean of the
    control and treatment groups. Also the secondary efficacy endpoints will be analysed by comparing the
    means of outcomes between the control and treatment groups. The primary criterion is the UEMS recovery score at day 168.
    No interim analysis is planned.
    E.5.2Secondary end point(s)
    Effect on motor and sensory function according to the ISNCSCI protocol (ASIA impairment scale,
    ASIA lower extremities motor score (LEMS) and sensory scores (light touch (LT), pin prick (PP)).
     Effect on autonomic dysfunction (i.e. bladder function as measured by bladder diary, Qualiveen
    questionnaire, bladder function questionnaire)
     Effect on functioning evaluated by the Spinal Cord Independence Measure (SCIM-III).
     Effect on hand/upper limb function as assessed by the Graded and Redefined Assessment of
    Strength, Sensibility and Prehension (GRASSP) subscales.
     Effect on the Walking Index for Spinal Cord Injury (WISCI), 10 meter walk test (10mWT) and the 6‐
    minute walking test (6MWT).
     Effect on neurophysiological parameters (nerve conducting velocity, Somatosensory evoked
    potentials)
     To evaluate the pharmacokinetics (PK) and immunogenicity of NG-101.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the exact time points of evaluation refer to assessment schedule.
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity. One of the secondary outcome measures for this clinical trial is the assessment of the
    pharmacokinetic (PK) and immunogenicity of NG-101 based on serial samples. The concentrations
    of NG-101 in serum and CSF will be analyzed by validated enzyme-linked immunosorbent assay
    (ELISA) methods. Samples for analysis of anti-NG-101 immunogenicity (antibody detection) will be
    screened using an immunoassay and possibly go through other characterization assays.
    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 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 EEA9
    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
    Czech Republic
    Italy
    Spain
    Switzerland
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 132
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state95
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 132
    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
    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 Decision2018-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-19
    P. End of Trial
    P.End of Trial StatusOngoing
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