Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   43202   clinical trials with a EudraCT protocol, of which   7150   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Pilot trial of recombinant human growth hormone for remyelination in multiple sclerosis

    Summary
    EudraCT number
    2006-006465-16
    Trial protocol
    DE  
    Global end of trial date
    15 Mar 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Jul 2020
    First version publication date
    04 Jul 2020
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    rhGH in MS
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01541605
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University of Leipzig
    Sponsor organisation address
    Ritterstr. 26, Leipzig, Germany, 04109
    Public contact
    Prof. Dr. F. Then Bergh , Klinik und Poliklinik für Neurologie Universität Leipzig , ThenBerF@medizin.uni-leipzig.de
    Scientific contact
    Prof. Dr. F. Then Bergh , Klinik und Poliklinik für Neurologie Universität Leipzig , ThenBerF@medizin.uni-leipzig.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Nov 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To rule out an increase in inflammatory disease activity by s.c. rhGH as detected by monthly contrast-enhanced MRI: Primary outcome measure is the cumulative number of active (new or gadolinium-enhancing) lesions during the 12-week baseline period and the first 12 weeks of the treatment period.
    Protection of trial subjects
    There were two safety assessments earlon on in the trial: 1) Major increase in inflammatory disease activity by s.c. rhGH. An clinical safety assessment will be performed after four patients have completed week 12 of rhGH treatment. The study may be discontinued, if more than 2 out of the first four patients fulfill the following condition: The cumulative number of new active lesions during the treatment phase exceeds the maximum of 12 and is more than twice the cumulative number of new active lesions during the baseline period. 2) Significant increase in clinical disease activity. A second clinical safety assessment is planned when 15 patients have completed 24 weeks of rhGH treatment. The study may be discontinued if more than 30% of these patients display a clinically significant increase of the relapse rate or neurological disability inconsistent with prior disease history and not explained by other intervening variables. The patients were also closely watched for serious unexpected adverse drug reactions, serious unexpected interactions with immunomodulatory treatments for MS (interferon-beta, copolymer-1) / not justifiable toxicity
    Background therapy
    -
    Evidence for comparator
    Cross-over design; no active comparator.
    Actual start date of recruitment
    19 Jun 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 37
    Worldwide total number of subjects
    37
    EEA total number of subjects
    37
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    37
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Only subjects who met all inclusion criteria, but none of the exclusion criteria specified for the screening phase were enrolled.

    Period 1
    Period 1 title
    Screening
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    pre-treatment
    Arm description
    -
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    pre-treatment
    Started
    37
    Completed
    25
    Not completed
    12
         exclusion criteria for treatment phase
    12
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    Yes [1]
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    recombinant growth factor
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Recombinant human growth hormone (rhGH)
    Investigational medicinal product code
    H01AC01
    Other name
    Genotropin®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Then dosage was induividually adjusted to achieve an IGF-1 concentration in the upper quartile of the age-adjusted normal range.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Period 1 is the screening period. The screening period had a duration of 12 weeks, including regular visits and assessements. Data from the screening period was used as baseline data for the evaluation of trial endpoints. However, only patients eventually included into the treatment phase are analysed, and therefore baseline data is reported for patients who entered the second period only.
    Number of subjects in period 2 [2]
    recombinant growth factor
    Started
    25
    Completed
    22
    Not completed
    3
         Physician decision
    1
         Adverse event, non-fatal
    1
         Consent withdrawn by subject
    1
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Period 1 is the screening period. The screening period had a duration of 12 weeks, including regular visits and assessements. Data from the screening period was used as baseline data for the evaluation of trial endpoints. However, only patients eventually included into the treatment phase are analysed, and therefore baseline data is reported for patients who entered the second period only.

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Treatment
    Reporting group description
    -

    Reporting group values
    Treatment Total
    Number of subjects
    25 25
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    45.2 ± 10.0 -
    Gender categorical
    Units: Subjects
        Female
    10 10
        Male
    15 15
    Type of MS
    Units: Subjects
        relapsing-remitting
    23 23
        secondary progressive
    2 2
    Number of MS episodes in the last two years
    Units: Subjects
        No episodes
    9 9
        One episode
    7 7
        Two episodes
    1 1
        Three episodes
    4 4
        Five episodes
    2 2
        Seven episodes
    1 1
        Not available
    1 1
    Time since MS diagnosis
    Units: years
        median (full range (min-max))
    5 (0.3 to 35.4) -
    EDSS score
    Units: number
        arithmetic mean (standard deviation)
    3.4 ± 1.5 -

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    pre-treatment
    Reporting group description
    -
    Reporting group title
    recombinant growth factor
    Reporting group description
    -

    Primary: Ratio pre/post of number of active lesions on brain MRI

    Close Top of page
    End point title
    Ratio pre/post of number of active lesions on brain MRI [1]
    End point description
    Cumulative number of active (i.e. 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.
    End point type
    Primary
    End point timeframe
    24 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This is a single arm trial. Reporting of statistical analyses in this database require at least two arms, otherwise an error message occurs.
    End point values
    recombinant growth factor
    Number of subjects analysed
    25
    Units: ratio
        number (confidence interval 95%)
    1.82 (0.72 to 2.92)
    No statistical analyses for this end point

    Secondary: Change in VEP P100 latencies versus baseline

    Close Top of page
    End point title
    Change in VEP P100 latencies versus baseline
    End point description
    End point type
    Secondary
    End point timeframe
    Pre / Post difference
    End point values
    recombinant growth factor
    Number of subjects analysed
    24
    Units: ms
        number (confidence interval 95%)
    -2.2 (-8.3 to 3.8)
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded at every visit from visit 2 (-8 weeks) until the follow-up visit (week 36).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0?
    Reporting groups
    Reporting group title
    Safety set
    Reporting group description
    -

    Serious adverse events
    Safety set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 37 (8.11%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Hepatobiliary disorders
    Autoimmune hepatitis
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Non-alcoholic fatty liver
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Safety set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 37 (78.38%)
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    2 / 37 (5.41%)
         occurrences all number
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 37 (5.41%)
         occurrences all number
    2
    Investigations
    Glycosylated haemoglobin increased
         subjects affected / exposed
    8 / 37 (21.62%)
         occurrences all number
    8
    Blood potassium increased
         subjects affected / exposed
    3 / 37 (8.11%)
         occurrences all number
    4
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 37 (8.11%)
         occurrences all number
    3
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    3 / 37 (8.11%)
         occurrences all number
    3
    Hepatic enzyme increased
         subjects affected / exposed
    3 / 37 (8.11%)
         occurrences all number
    3
    Platelet count increased
         subjects affected / exposed
    2 / 37 (5.41%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 37 (10.81%)
         occurrences all number
    4
    Epistaxis
         subjects affected / exposed
    2 / 37 (5.41%)
         occurrences all number
    6
    Pharyngeal erythema
         subjects affected / exposed
    2 / 37 (5.41%)
         occurrences all number
    2
    Nervous system disorders
    Hypoaesthesia
         subjects affected / exposed
    2 / 37 (5.41%)
         occurrences all number
    3
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    4 / 37 (10.81%)
         occurrences all number
    5
    Influenza like illness
         subjects affected / exposed
    3 / 37 (8.11%)
         occurrences all number
    3
    Oedema peripheral
         subjects affected / exposed
    3 / 37 (8.11%)
         occurrences all number
    3
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    2 / 37 (5.41%)
         occurrences all number
    2
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    2 / 37 (5.41%)
         occurrences all number
    2
    Renal and urinary disorders
    Leukocyturia
         subjects affected / exposed
    3 / 37 (8.11%)
         occurrences all number
    5
    Proteinuria
         subjects affected / exposed
    2 / 37 (5.41%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    3 / 37 (8.11%)
         occurrences all number
    3
    Erythema
         subjects affected / exposed
    3 / 37 (8.11%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    3 / 37 (8.11%)
         occurrences all number
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    9 / 37 (24.32%)
         occurrences all number
    12
    Urinary tract infection
         subjects affected / exposed
    4 / 37 (10.81%)
         occurrences all number
    4

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Sep 2008
    Change in trial product
    31 Mar 2009
    Change in an inclusion criterion
    26 Nov 2009
    Change in selection criteria
    01 Jul 2010
    Safety laboratory values added
    16 Nov 2010
    Extension of trial period
    04 Oct 2011
    Change in trial flow chart
    10 Dec 2012
    Extension of trial period
    16 Dec 2014
    Extension of trial period

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA