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    Clinical Trial Results:
    TMP001 in relapsing-remitting multiple sclerosis: a multicentre open, baseline-controlled phase IIa clinical trial

    Summary
    EudraCT number
    		 2014-004483-38
    Trial protocol
    		 DE  
    Global end of trial date
    20 Apr 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jun 2022
    First version publication date
    13 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TMP001_MS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fraunhofer Gesellschaft for its Institute Fraunhofer Institute for Molecular Biology and Applied Ecology (IME) - now ITMP
    Sponsor organisation address
    Theodor-Stern-Kai 7, Frankfurt, Germany, 60596
    Public contact
    Project group TMP, Fraunhofer IME, Clinical Research, 0049 69630180208, clinical.research@ime.fraunhofer.de
    Scientific contact
    Project group TMP, Fraunhofer IME, Clinical Research, 0049 69630180208, clinical.research@ime.fraunhofer.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
    14 Apr 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Average total number of contrast enhancing lesions (CELs) on brain MRI scans at weeks 12, 16, 20, and 24 compared to the average total number of CELs on brain MRI scans at week -4 and baseline (BL).
    Protection of trial subjects
    Subjects were included after assessing adherence to inclusion and exclusion criteria. Safety lab was performed at each study visit: Haematology, blood chemistry, coagulation and urinalysis were done every 4 weeks, intracellular cytokine profiles were measured and incidence and severity of AEs assessed and documented
    Background therapy
    		 patients with relapses may be treated, e.g. with intravenous In case of relapses methylprednisolone 1000 mg per day for 3 to 5 days was allowed. The following concomitant medications were also allowed: • 4-aminopyridine if used per label and maintained on a stable regimen for at least 30 days prior to inclusion and throughout the study. • Medications used to treat MS symptoms such as spasticity, bladder impairment, pain, or depression. • Short courses of high-dose corticosteroids per local standard of care in the treatment of protocol-defined relapse of MS disease. • Corticosteroids that are administered by non-systemic routes (e.g., topical, inhaled)
    Evidence for comparator
    		 no comparator
    Actual start date of recruitment
    01 Jun 2015
    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: 4
    Worldwide total number of subjects
    4
    EEA total number of subjects
    4
    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)
    4
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patient with relapsing remitting Multiple Sclerosis (RRMS) were screened for eligibility and included in the study. Recruitment started 14.04.2016

    Pre-assignment
    Screening details
    		 Patients fulfilling inclusion criteria had a run-in phase for 28 days. Definite diagnosis of RRMS, at least 1 documented relapse during the previous year OR at least 2 documented relapses during the previous 2 years, at least one contrast-enhancing lesion (CEL) on screening MRI

    Period 1
    Period 1 title
    treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    No blinding required since all patient received study treatment in a baseline-controlled design

    Arms
    Arm title
    		 treatment
    Arm description
    		 all subjects received treatment: Patients with relapse-remitting multiple sclerosis (RRMS) were treated with TMP001 600mg twice daily over a treatment period of 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TMP001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    gelatin capsules, each containing 200 mg of the active drug substance, for oral administration at daily doses of up to 1200 mg in two divided doses over a period of 24 weeks

    Number of subjects in period 1
    		treatment
    Started
    4
    Completed
    2
    Not completed
    2
         Consent withdrawn by subject
    1
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    treatment period
    Reporting group description
    		 patient included after screening

    Reporting group values
    		 treatment period Total
    Number of subjects
    		 4 4
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 4 4
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 2 2
    height
    Units: meter
        arithmetic mean (standard deviation)
    		 1.755 ( 0.095 ) -
    Body mass index
    Units: kilogram(s)/cubic metre
        arithmetic mean (standard deviation)
    		 22.26 ( 1.84 ) -

    End points

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    End points reporting groups
    Reporting group title
    treatment
    Reporting group description
    		 all subjects received treatment: Patients with relapse-remitting multiple sclerosis (RRMS) were treated with TMP001 600mg twice daily over a treatment period of 24 weeks.

    Primary: number of CEL lesions at weeks 12, 16, 20 and 24

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    End point title
    		 number of CEL lesions at weeks 12, 16, 20 and 24 [1]
    End point description
    Average total number of contrast enhancing lesions (CELs) on brain MRI scans at weeks 12, 16, 20, and 24 as compared to the average total number of CELs on brain MRI scans at week -4 and baseline (BL)
    End point type
    Primary
    End point timeframe
    Baseline to week 12, 16, 20 and 24
    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: Since only a small number of patients could be enrolled statistical analysis was not feasible and was not done
    End point values
    		 treatment
    Number of subjects analysed
    0 [2]
    Units: number
        number (not applicable)
    Notes
    [2] - not enough patients were included no summary could have been or has been done
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    run-in phase until end of treatment in week 24
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    treatment
    Reporting group description
    		 all patients that received a minimum of one dose of treatment

    Serious adverse events
    		 treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    abdominal pain
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Bursitis
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jul 2015
    Protocol version 1.9 of 15.06.2015 Patient Information and Consent Form version 1.3 of 15.06.2015 Reasons: Additional information about an increased risk of cardiovascular side effects for NSAID Expanded inclusion and exclusion criteria Collection of coagulation status in the Safety Labor Change of a subinvestigator at an existing site
    17 Sep 2015
    Addition of new site
    19 Jan 2016
    Protocol version 2.0 of 14.01.2016 Protocol version 2.1 of 05.02.2016 Patient Information and Consent Form version 1.4 of 14.01.2016 Investigator’s Brochure (IB) version 05 of 08.12.2015 IMPD version 2.0 of 19.01.2016 Reasons: Specification of the used MRI protocol Sensitivity of MRI was increased to detect lesions with feeble contrast agent enhancing abilities Investigator’s Brochure (IB): Data from the phase I study with healthy volunteers were entered
    21 Mar 2016
    Addition of a new site
    07 Sep 2016
    Protocol version 3.0 of 03.08.2016 Patient Information and Consent Form version 2.0 of 03.08.2016 Patients Flyer version 1.1 of 18.08.2016 Reasons: Removal of brain MRIs on week 4 and week 8 New contact details
    07 Mar 2017
    Protocol version 4.0 of 02.03.2017 Investigator's brochure (IB) version 5.0 of 22.02.2017 Reasons: Extension of study duration until Q4/2017 Changes in the executive management of Fraunhofer IME Update Investigator's brochure (IB)

    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.
    only a small number of patients were enrolled in the study therefor no statistical analysis could be made. Since all efforts for enable and facilitate recruitment failed study was closed.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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