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    Summary
    EudraCT Number:2014-004483-38
    Sponsor's Protocol Code Number:TMP001_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:2015-04-28
    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 number2014-004483-38
    A.3Full title of the trial
    TMP001 in relapsing-remitting multiple sclerosis: a multicentre open, baseline-controlled phase IIa clinical trial
    TMP001 bei schubförmig-remittierender Multipler Sklerose - eine multizentrische, offene, Baseline-kontrollierte Phase IIa Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TMP001 in relapsing-remitting multiple sclerosis: a multicentre open, baseline-controlled phase IIa clinical trial
    A.4.1Sponsor's protocol code numberTMP001_MS
    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 SponsorFraunhofer Gesellschaft for its Institute Fraunhofer Institute for Molecular Biology and Applied Ecology (IME)
    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 supportBundesministerium für Bildung und Forschung
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFraunhofer IME, Clinical Research
    B.5.2Functional name of contact pointProject group TMP
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Stern-Kai 7
    B.5.3.2Town/ cityFrankfurt a.M.
    B.5.3.3Post code60590
    B.5.3.4CountryGermany
    B.5.4Telephone number004969630180208
    B.5.5Fax number004969630180248
    B.5.6E-mailclinical.research@ime.fraunhofer.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 nameTarenflurbil
    D.3.2Product code TMP001
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTarenflurbil
    D.3.9.1CAS number 5104-49-4
    D.3.9.3Other descriptive nameFLURBIPROFEN
    D.3.9.4EV Substance CodeSUB07745MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) 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 No
    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
    Patients with defined diagnosis of relapsing-remitting multiple sclerosis and at least 1 documented relapse during the previous year OR at least 2 documented relapses during the previous 2 years.
    Patienten mit diagnostizierter schubförmig-remittierender Multipler Sklerose und mindestens einem dokumentierten Schub im vergangenen Jahr ODER mindestens zwei dokumentierten Schüben in den vergangenen zwei Jahren.
    E.1.1.1Medical condition in easily understood language
    Patients with defined diagnosis relapsing-remitting multiple sclerosis at least 1 documented relapse during the previous year OR at least 2 documented relapses during the previous 2 years.
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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).
    E.2.2Secondary objectives of the trial
    - Average total volume of CELs (in mm3) on brain MRI scans at week 12, 16, 20 and 24 compared to the average CEL volume on brain MRI at week -4 and baseline (BL)
    - New or enlarged T2-hyperintense lesions at week 24 as compared to BL
    - New T1-hypointense lesions at week 24 as compared to BL
    - Annualised relapse rate
    - EDSS at week 12 and 24 as compared to BL
    - Lipid profile at week 12 and 24 as compared to BL
    - Assessment of TMP001-concentrations
    - Pain questionnaire at BL, week 12 and week 24
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 18 to 55 years
    • Definite diagnosis of RRMS (according to revised McDonald criteria, Polman et al. 2011, Ann Neurol 69:292-302)
    • 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 the screening MRI scan at week -4
    • EDSS of 0 – 5 (inclusive) at screeing (week -4)
    • Women of childbearing potential (WOCBP) must use 2 adequate forms of contraception to avoid pregnancy throughout the trial (such as a double barrier method) and for up to 8 weeks after the last dose of TMP001 in such a manner that the risk of pregnancy is minimized
    • Written informed consent obtained prior to the initiation of any protocol-required procedures
    • Compliance to study procedure and study protocol
    E.4Principal exclusion criteria
    • History of chronic disease of the immune system other than MS or a known immunodeficiency syndrome
    • Clinically severe active infection (e.g., pneumonia, septicaemia) within the 1 month prior to Screening.
    • Diagnosis of neuromyelitis optica, clinically isolated syndrome, secondary progressive multiple sclerosis, or primary progressive multiple sclerosis
    • History of drug or alcohol abuse within 2 years of inclusion to the study
    • Relapse or corticosteroid treatment within 30 days before screening (week -4)
    • Interferon-beta, glatiramer acetate, teriflunomide, dimethyl fumarate or fingolimod therapy had to have been stopped 3 or more months before enrolment
    • Immunosuppressive medication such as azathioprine or methotrexate, Ciclosporin, cyclophosphamide, mycophenolate mofetil, mitoxantrone or cladribine at any time
    • Any previous therapy with alemtuzumab, ocrelizumab, ofatumumab, rituximab, belimumab, natalizumab, total body irradiation, or bone marrow transplantation
    • Any investigational drug or placebo within 12 weeks prior to enrolment OR > 5 half-lives prior to screening (week -4), whichever is longer
    • Women that are pregnant or currently breast feeding
    • Concurrent participation in other clinical trials
    • History of, or current diagnosis of, malignancy (including previously treated skin cancer other than successfully treated basal and squamous skin cancer with no evidence of recurrence within 5 years)
    • Inability to complete an MRI or contraindications for MRI, including but not limited to claustrophobia, presence of a pacemaker, cochlear implants, ferromagnetic devices or clips, intracranial vascular clips, insulin pumps, or nerve stimulators
    • Hypersensitivity to contrast agent (Gadolinium, resp. Gadopentetat-Dimeglumin)
    • Any reason in the discretion of the investigator regarding the safe participation of the patient in the study or for any other reason, the investigator considers the patient inappropriate for participation in the study.
    • White blood count (WBC) <3000 mm3 at screening (week -4)
    • Lymphocytes < 800 mm3 at screening (week -4)
    • Known renal insufficiency stage III or higher (eGFR ≤ 59ml/min/1.73 m2; according to the Kidney Disease Outcomes Quality Initiative (KDOQI))

    Exclusion criteria regarding the study medication:
    • Patients with known hypersensitivity to study medication
    • Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
    • Patients with a history of peptic ulcer disease and/or gastrointestinal bleeding
    • Chronic or acute renal, hepatic or metabolic disorder
    •Patients with a history of myocardial infarction, ischemic stroke or known heart failure
    •Patients with known thrombophilia or abnormal clinically significant coagulation parameter at screening (week -4)

    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint efficacy:
    - Average total number of contrast enhancing lesions (CELs) on brain MRI scans at week 12, 16, 20 and 24 as compared to the average total number of CELs on brain MRI scans at week -4 and week 0 (baseline)
    E.5.1.1Timepoint(s) of evaluation of this end point
    week -4, week 0 (baseline), 12, 16, 20, and 24
    E.5.2Secondary end point(s)
    Secondary endpoints efficacy:
    - Average total volume of CELs (in mm3) on brain MRI scans at week 12, 16, 20 and 24 as compared to the average CEL volume on brain MRI scans at week -4 and week 0 (baseline)
    - New or enlarged T2-hyperintense lesions at week 24 compared to baseline
    - New T1-hypointense lesions at week 24 as compared to baseline
    - annualised relapse rate
    - EDSS at week 12 and 24 as compared to baseline
    - Lipid profile at week 12 and 24 as compared to baseline
    - Assessment of TMP001-concentrations
    - Pain questionnaire at baseline, week 12 and week 24

    Main parameters of safety:
    - haematology, blood chemistry and urinanalysis every 4 weeks
    - intracellular cytokine profiles
    - incidence and severity of AEs
    E.5.2.1Timepoint(s) of evaluation of this end point
    week -4, week 0 (baseline), 12, 16, 20, and 24
    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 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 No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    baseline-controlled
    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
    baseline-controlled
    E.8.2.4Number of treatment arms in the trial1
    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 concerned5
    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 No
    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
    Time point of study closure at each site
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 55
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state55
    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)
    Treatment with TMP001 beyond the termination of the study is not planned. Treatment with TMP001 will be stopped for each patient by study end. The investigator will inform the patients about all available standard-of-care treatments and the decision is left to the patient’s and investigator’s discretion.
    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 Decision2015-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-20
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