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    Summary
    EudraCT Number:2005-005985-35
    Sponsor's Protocol Code Number:1206.15
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-08-02
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2005-005985-35
    A.3Full title of the trial
    A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis.
    A.4.1Sponsor's protocol code number1206.15
    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 SponsorBoehringer Ingelheim Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsor
    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 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.3.2Product code BIRT 2584 XX
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 688756-00-5
    D.3.9.2Current sponsor codeBIRT 2584 XX
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    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 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.3.2Product code BIRT 2584 XX
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 688756-00-5
    D.3.9.2Current sponsor codeBIRT 2584 XX
    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) 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 Information not present in EudraCT
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing forms of Multiple Sclerosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting 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 evaluate the dose dependent effect BIRT 2584 XX tablets (100 mg, 300 mg, or 500 mg) administered orally once daily (compared to placebo tablets) for the treatment of patients with relapsing forms of Multiple Sclerosis.
    E.2.2Secondary objectives of the trial
    To characterise the PK of BIRT 2584 XX tablets (100 mg, 300 mg, or 500 mg) in patients with relapsing forms of Multiple Sclerosis in an exploratory fashion.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic sub study is part of this main protocol 1206.15
    E.3Principal inclusion criteria
    1. Male or female patients aged 18-55 years.
    2. Diagnosis of MS according to the revised McDonald criteria (R06-0788).
    3. Score of 0 5.5 on the Kurtzke EDSS at screening.
    4. Screening MRI must show at least three lesions on the T2 scan with a size of at least 3 mm (to be determined by Investigator and confirmed by the Central MRI evaluation).
    5. At least one clearly identified documented relapse, subsequent to diagnosis, within 12 months prior to screening, and disease duration from onset of relapse > 6 months
    or
    two documented relapses in the last 24 months
    or
    one documented relapse between 12 and 24 months before screening if there is > 1 documented enhancing lesion in a brain-spinal cord MRI performed within 2 months prior to screening.
    6. Clinically stable, and without relapse within 30 days of Visit 1. If a patient should experience a relapse between Visit 1 and Visit 2, they can be re-screened for inclusion in the trial once only.
    7. The patient or the patient’s legally acceptable representative must be able to give informed consent in accordance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and local legislation.
    8. Subject must be willing and able to comply with the protocol requirements for the duration of the study.
    E.4Principal exclusion criteria
    1. Clinically significant disease or medical condition other than MS or MS-related conditions that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied.
    2. Patients with non-relapsing, progressive MS.
    3. Patients with conditions that could interfere with the MRI or any other evaluation in this trial.
    4. Patients with a known allergy to gadolinium containing contrast agents
    5. Patients who have received methylprednisolone and or oral prednisone in the four weeks prior to Visit 1.
    6. Patients who have received Tysabri® (nataluzimab) or have received treatment with any VLA-4 antagonist at any time.
    7. Patients who are receiving, or who have received monoclonal antibodies within six months prior to Visit 1.
    8. Patients who are receiving, or who have received mitoxantrone or cladribine within 1 year prior to Visit 1.
    9. Patients who are receiving, or who have received beta-interferons, azathioprine, cyclophosphamide, methotrexate or copaxone within three months prior to Visit 1.
    10. Patients who have received total lymphoid irradiation at any time.
    11. Patients using treatments that could interfere with the primary endpoint of the trial.
    12. Patients on treatment with warfarin, paracetamol (acetaminophen), some non-steroidal anti-inflammatory drugs (NSAIDs), some antidepressants, medications known to induce or inhibit CYP3A/4, or any other concomitant medication where potential drug-drug interactions with BIRT 2584 XX could either result in decreased efficacy or an unacceptable benefit-risk assessment, and where replacement of that concomitant medication with a safe equivalent drug is not possible.
    13. Patients with active liver disease or history of any significant liver disease.
    14. Patients with serum creatinine and/or WBC count > 1.5 x ULN at screening (Repeat laboratory is allowed once between screening and randomisation prior to excluding the patient).
    15. Patients with ALT, AST and/or total bilirubin > 1.5xULN at screening. (Repeat laboratory is allowed once between screening and randomisation prior to excluding the patient).
    16. Patients with abnormal values of other laboratory parameters that would define a clinically significant disease as described in # 1 above.
    17. Patients with a history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C (or who have a positive test at screening ), or any serious infection (requiring hospitalisation or parenteral antibiotic therapy) in the past 3 months prior to screening.
    18. Patients with a history of malignancy in the past 5 years or suspicion of active malignant disease except treated cutaneous squamous cell or basal cell carcinoma.
    19. Patients with the following findings at the screening visit that could interfere with cardiac repolarisation :
    • marked baseline prolongation of QT/QTC interval as measured on ECG (e.g. QTC interval > 450ms);
    • history of additional risk factors for Torsade de pointe (e.g. heart failure, - hypokalemia, family history of long QT syndrome);
    • use of concomitant medications that prolong the QT/QTC interval.

    20. Patients with known relevant substance abuse, including alcohol or drug abuse. The intention of this criterion is to exclude patients who are considered to be at risk of not complying with or abusing the trial medication administration directives.
    21. Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women who:
    • are pregnant or nursing;
    • are of child bearing potential and not practicing an acceptable method of birth control, or does not plan to continue practising a acceptable method of birth control throughout the trial (Acceptable methods of birth control are intrauterine devices (IUD), surgical sterilisation, double barrier, or vasectomised partner, but not hormonal contraceptives );
    22. A negative serum pregnancy test at screening (Visit 1) and a negative urine test prior to randomisation (Visit 2) are required.
    23. Patients who have participated in another trial with an Investigational drug within the last 4 weeks or 5 half-lives (whichever is greater) preceding the screening visit.
    24. Patients with a known allergy to BIRT 2584 XX or to the excipients used for tablet formulation.
    25. Patients not willing or able to comply with the protocol requirements for the duration of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Cumulative number of newly active unique lesions on MRI scans from week 4 to 24 inclusive. Newly active unique lesions result from combining;
    Newly enhancing lesions on T1-weighted contrast enhanced scans

    and

    New and newly enlarging lesions on proton density/T2-weighted scans, but non-enhancing on T1-weighted scans
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of trial is defined as the last patient attending the last clinic visit (Visit 13). Visit 13 is 8 weeks after the last dose of study medication
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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) 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 216
    F.4.2.2In the whole clinical trial 320
    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)
    Patients will return to the treatment deemed appropriate by their physician. Due to the early phase of this study, there will be no provision for patients to continue on study 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 Decision2006-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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