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    Summary
    EudraCT Number:2006-006465-16
    Sponsor's Protocol Code Number:rhGH in MS
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-05-03
    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 ConcernedGermany - BfArM
    A.2EudraCT number2006-006465-16
    A.3Full title of the trial
    Pilot trial of recombinant human growth hormone for remyelination in multiple sclerosis
    A.3.2Name or abbreviated title of the trial where available
    rhGH in MS
    A.4.1Sponsor's protocol code numberrhGH in MS
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Leipzig
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Genotropin
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacia GmbH / Pfizer
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameGenotropin
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNhuman recombinant growth hormone
    D.3.9.1CAS number 12629-01-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 to 12
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Multiple Sclerosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10063400
    E.1.2Term Secondary progressive multiple sclerosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To rule out a major increase in inflammatory disease activity by s.c. hGH using high-frequency contrast-enhanced brain MRI
    E.2.2Secondary objectives of the trial
    To demonstrate clinical safety of s.c. hGH in MS

    To provide initial data on therapeutic efficacy of hGH in MS (surrogate marker)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Imaging of human remyelination by non-conventional MRI:

    MRI examinations at screening, baseline, months 3 and 6 will include acquisition of short T2 relaxation sequences, MR spectroscopy, diffusion tensor imaging and magnetization transfer imaging. These quantitative, longitudinal data will be related to a) the process of relapsing and remitting focal inflammation, b) the evolution of VEP latencies, and c) the administration of s.c. rhGH.
    Correlation to the time course of inflammation will result in better understanding of the interplay of inflammation and remyelination, and to an improved estimation of the time point at which attempts at remyelination should be initiated. A correlation of improvements in VEP latency and MRI measures will support the value of the latter as an imaging procedure to evaluate clinical trials of remyelinating agents. Significant relations between hGH treatment and improvement in either of the variables (VEP or MRI) can be taken as supportive data in terms of remyelination induction by rhGH.
    E.3Principal inclusion criteria
    Age 18-55 years (included), female or male

    MS according to McDonald criteria, 2005 revision (Polman et al., 2005)

    Relapsing-remitting (RRMS) or secondary progressive (SPMS) course

    EDSS 0 – 5.5 (included)

    Time since resolution of the last relapse or dose of corticosteroid treatment at least six weeks

    Time since onset of a clinically manifest episode of optic neuritis at least one year

    Pathological prolongation of visual evoked potentials on at least one eye, documented to be stable for at least three months

    On screening MRI, at least three supratentorial lesions in T2/FLAIR

    All patients must give written consent for participation in the study prior to the screening
    E.4Principal exclusion criteria
    Primary progressive course of MS (PPMS)

    More than four Gd contrast enhancing lesions on screening MRI

    Ophthalmologic condition associated with impaired visual acuity, visual field cuts or other impairment of visual function, other than related to MS; glaucoma stable under regular treatment is acceptable

    Treatment with an immunosuppressive agent (azathioprine, mitoxanthrone, methotrexate), natalizumab or any monoclonal antibody within six months before start of rhGH treatment

    History of chronic disease of the immune system other than MS or of a known immunodeficiency syndrome

    Diabetes mellitus, pathological percentage of HbA1c at screening

    Patients with a history of malignancy or lymphoproliferative disorder, or current malignant tumor of any type or location

    Patients unable to undergo MRI scans, including claustrophobia or history of severe hypersensitivity to gadolinium

    Dementia/severe cognitive deficits

    Patients with thyroid diseases (unless an individual consultion with an endocrinologist justifies participation)

    Contraindication to the planned therapy (e. g. hypersensitivity to trial medication or one of its components)

    Ongoing drug abuse

    HIV positive

    Pregnant or nursing women

    Women with child bearing potential without effective contraception (a highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed).

    Expected low compliance

    Concomitant participation in other clinical trials

    Contraindication to the planned therapy as per Summary of Prescribing Information (Fachinformation): Suspected progression or reappearance of intra-cranial mass lesions; patients suffering from acute major disease, which resulted from experiencing complications after heart or abdominal surgery, after multiple accidental trauma or respiratory failure; Prader-Willi-Syndrome
    E.5 End points
    E.5.1Primary end point(s)
    Cumulative number of active (new or gadolinium-enhancing) lesions on brain MRI performed every four weeks during the 12-week baseline period and the first 12 weeks of the treatment period. That is, numbers of active lesions from week –8, week –4 and baseline will be compared to numbers of active lesions from week 4, week 8 and week 12.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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 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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    single cross-over, i.e. patients serve as their own control (baseline vs. treatment period)
    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 Information not present in EudraCT
    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
    last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-05-03. Yes
    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 state30
    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)
    After completion of the study, patients will be treated by their respective neurologist, according to published guidelines. Additional care at the trial site’s neuroimmunology clinic at regular intervals will be offered to all participants. All participants will be contacted directly if a phase-III-study will be performed or/and in case of positive results from a potential phase-III-study leading to approval of rhGH treatment.
    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 Decision2007-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-15
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