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    Summary
    EudraCT Number:2010-020679-21
    Sponsor's Protocol Code Number:CS/München 02
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-11-30
    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 - BfArM
    A.2EudraCT number2010-020679-21
    A.3Full title of the trial
    Growth hormone and gonadotropin deficiency after brain injury (traumatic brain injury, subarachnoidal hemorrhage, ischemic stroke): the effects of hormone replacement on cognition,quality of life and body composition
    A.3.2Name or abbreviated title of the trial where available
    IHGD/Testo Stud
    A.4.1Sponsor's protocol code numberCS/München 02
    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 SponsorMax-Planck-Institut für Psychiatrie
    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 5 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacia GmbH
    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 5 mg/ml
    D.3.4Pharmaceutical form Powder and solvent for 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 INNSOMATROPIN
    D.3.9.1CAS number 12629-01-5
    D.3.9.2Current sponsor coden.a.
    D.3.9.3Other descriptive namen.a.
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    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 Nebido 1000 mg Injektionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderBeyer Schering Pharma AG
    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 nameNebido Injektionslösung 1000 mg
    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 IMPIntramuscular use
    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) 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
    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 placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    hormonal deficiency after traumatic brain injury, subarachnoidal hemorrhage and ischemic stroke)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10022466
    E.1.2Term Insufficiency pituitary
    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 changes in QoL
    a) in patients with GH-treatment for 6 months before and after treatment and in comparison to control patients and
    b) in patients with testosterone-replacement for 18 weeks before and after treatment and in comparison to patients receiving placebo.
    E.2.2Secondary objectives of the trial
    To evaluate differences (Δ) in cognitve function in patients with GH-treatment after 6 months compared to untreated control patients.

    To evaluate differences (Δ) in cognitive function in patients with testosterone-treatment for 18 weeks compared to patients receiving placebo or 6 months GH-treatment.

    To evaluate differences (Δ) in body composition in patients with GH-treatment after 6 months compared to control patients.

    To evaluate differences (Δ) in body composition in patients with testosterone-treatment for 18 weeks compared to patients receiving placebo or receiving 6 months GH-treatment.

    To evaluate changes in degree of reorganization of brain activity in control patients and in patients with and without GH treatment after 6 months.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Study group 1:
    1) Adult patients between 18 and 65 years
    2) Female and male
    3) Stable phase after brain injury as judged by the neurologist after TBI, SAH or
    ischemic stroke before screening
    4) Stable substitution of other hormonal axes
    5) GH level < 6 ng/ml after stimulation with Insuline (ITT) or GH level below the
    cut-off in GHRH/arginine test using BMI-adjusted cut-off limits
    GHRH/arginine test should be done only in those patients with a
    contraindication for ITT (diabetes, uncontrolled seizures, heart pain) or in those
    patients who deny consent to ITT.
    6) Written informed consent by patient or a legally accepted representative

    Study group 2:
    1) Adult patients between 18 and 65 years
    2) Only males
    3) Prostate specific antigen (PSA) in normal range
    4) Stable phase after brain injury as judged by the neurologist after TBI , SAH or ischemic stroke before screening
    5) Stable substitution of other hormonal axes
    6) < 3.5 ng/ml testosterone (< 12.1 nmol/l)
    7) Written informed consent by patient or a legally accepted representative

    Study group 3:
    1) Adult patients between 18 and 65 years
    2) Female and male
    3) Stable phase after brain injury as judged by the neurologist after TBI, SAH or
    ischemic stroke before screening
    4) GH level < 6 ng/ml after stimulation with insuline (ITT) or GH level below the
    cut-off in GHRH/arginine test using BMI-adjusted cut-off limits
    GHRH/arginine test should be done only in those patients with a
    contraindication for ITT (diabetes, uncontrolled seizures, heart
    pain) or in those patients who deny consent to ITT.
    5) Written informed consent by patient or a legally accepted
    representative.
    E.4Principal exclusion criteria
    Study group 1 (GH-group)
    1. Pregnancy and lactation period (not applicable for male patients)
    2. Women of childbearing potential not using an adequate method of birth control
    (oral contraceptives and hormonal implants are not allowed).
    3. Men who are not willing to use an adequate method of birth control
    4. Previous or concomitant medication with GH
    5. Suspected or known hypersensitivity to GH
    6. Suspected or known drug or alcohol abuse
    7. Any condition which in the opinion of the investigator makes the patient
    unsuitable for inclusion
    8. Participation in another clinical trial with an investigational new drug
    9. Planned treatment or changes in established treatment with any other drug
    which might significantly influence the GH axis or the cognitive function (e.g.
    antidepressive treatment)
    10. Non-abiltiy to perform testing
    11. Presence of any other conditions listed in the contraindications or warnings in the
    local SPC of GH
    12. Onset of GH-deficiency before brain injury

    Study group 2 (testosterone/placebo group)
    1. Men who are not willing to use an adequate method of birth control
    2. Previous or concomitant medication with androgens or anabolic steroids within 12
    months of entry into the trial
    3. Suspected or known hypersensitivity to to the active substances or any of the
    excipients of Nebido® e.g. benzylbenzoate and castor oil
    4. Suspected or known drug or alcohol abuse
    5. Any condition which in the opinion of the investigator makes the patient
    unsuitable for inclusion
    6. Participation in another clinical trial with an investigational new drug
    7. Planned treatment or changes in established treatment with any other drug which
    might influence the gonadotrophic axis or the cognitive function (e.g.
    antidepressive treatment)
    8. Severe disturbances in articulation, visual faculty or hearing
    9. Presence of any other conditions listed in the contraindications or warnings in the l ocal SPC of testosterone (Nebido®)
    10. Onset of hormonal deficiency before brain injury
    11. Suspicion or known history of prostate or breast cancer or other hormone
    dependend neoplasia as well as history of malignancy within the last 5 years
    12. Abnormal finding on Digital Rectal Examination (DRE)
    13. Prostate specific antigen (PSA) level upper 4 ng/ml
    14. History of clinically significant post void residual urine (more than 150 ml) before
    brain injury
    15. Suspicion or known history of liver tumor
    16. Blood coagulation irregularities presenting an increased risk of bleeding after
    intramuscular injections including vitamin-K-antagonists or other strong
    anticoagulants
    17. Hypercalcemia accompanying malignant tumors
    18. Diagnosed sleep apnea
    19. Polycythemia
    20. Haematocrit level  50 % at entry to the study
    21. Concurrent use of dehydroepiandrosterone (DHEA), anabolic steroids,
    clomipramine, antiandrogens, estrogen, corticotrophics/ACTH, corticosteroids,
    oxyphenbutazone
    22. Uncontrolled thyroid disoders like diabetes mellitus (HbA1c  9 %) epilepsia,
    migraine, hypertension, coronary heart disease as well as hepatic, renal or cardiac
    insufficiency
    23. Patients requiring or undergoing fertility treatment
    24. Any condition which in the opinion of the investigator makes the patient
    unsuitable for inclusion e.g. chronic lung disease, chronic malabsorption disease
    25. Non-ability to perform cognitive testing
    26. Onset of androgen deficiency before brain injury

    Study group 3 (untreated control group)
    1. Previous or concomitant medication with androgens, growth hormone or anabolic
    steroids within 12 months of entry into the study
    2. Suspected or known drug or alcohol abuse
    3. Any condition which in the opinion of the investigator makes the patient
    unsuitable for inclusion
    4. Participation in another clinical trial with an investigational new drug
    5. Planned treatment or changes in established treatment with any other drug which
    might influence the gonadotrophic axis or the cognitive function (e.g.
    antidepressive treatment)
    6. Severe disturbances in articulation, visual faculty or hearing
    7. Non-ability to perform cognitive testing.
    E.5 End points
    E.5.1Primary end point(s)
    Changes (Δ) in score of SF-12, QoL-AGHDA, EQ-5 D, BDI, PSQI,
    QOLIBRI
    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 No
    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 No
    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
    group 1: open; group 2: double-blind, randomised, goup 3. open
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned2
    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
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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 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.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients after TBI, SAH or ischemic stroke often have legal representatives despite being able to give consent. Additional to the consent of the legal representative the patient has to give consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state68
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 68
    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)
    If the patient shows that the treatment was beneficial for his health, patients from group 2 may continue treatment on prescription according to the physicians advice because this is a registered indication. Patients from group 1 could continue on prescription if they have more than 1 pituitary deficiency according to current registration. Patients with isolated GH-deficiency can not continue the treatment. They will informed about that

    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 Decision2011-01-24
    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 StatusPrematurely Ended
    P.Date of the global end of the trial2015-03-31
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