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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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).

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    Summary
    EudraCT Number:2008-008713-20
    Sponsor's Protocol Code Number:BGC20-1531-04
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-02-02
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2008-008713-20
    A.3Full title of the trial
    EP4 receptor antagonism and PGE2 in a human headache model
    A.4.1Sponsor's protocol code numberBGC20-1531-04
    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 SponsorDanish Headache Center
    B.1.3.4CountryDenmark
    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 No
    D.2.1.1.1Trade name BGC20-1531
    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 nameBGC20-1531
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral 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 placeboCapsule*
    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
    PGE2 will induce headache in healthy subjects and BGC20-1531 or placebo will be used to block the developement of headache. In the future BGC20-1531 might be a possible anti-migraine drug.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Information not present in EudraCT
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is:
    • to investigate the blocking effects of two different single doses of the EP4 receptor antagonist, BGC20-1531, on PGE2-induced headache in healthy male and female subjects
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    • to investigate the blocking effects of two different single doses of BGC20-1531 on PGE2-induced drop in mean flow velocity in the middle cerebral artery (Vmean MCA), dilatation of superficial temporal artery (STA) and the radial artery (RA) in healthy subjects,
    • to investigate the effects of a single dose of BGC20-1531 on Vmean MCA and diameter of the STA and RA in healthy subjects.
    • to assess the pharmacokinetic/pharmacodynamic interactions of two different single doses of BGC20-1531.
    • to confirm the safety of single doses of BGC20-1531 in healthy subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Healthy trial subjects of either gender, 18–55 years of age.
    • Body Mass Index 21–29 kg/m2 [body mass index = body weight (kg) ÷ height (m)]2.
    • Fertile women must use reliable contraception; this does not apply to women who have had hysterectomies or to women 2 years post-menopause or longer. Reliable contraception is either an IUD + condom, birth control pills + condom, surgical sterilisation of the woman, or a depot gestagen.
    • Non-smokers or ex-smokers who have not smoked in the last 6 months (determined by urine cotinine < 500 ng/ml at screening).
    • No clinically significant out of range values in tests of serum biochemistry, hæmatology or urinalysis at screening (see Appendix 1).
    Negative urinary drugs of abuse screen at screening (see Appendix 1).
    • Negative HIV and hepatitis B and C results
    • Trial subjects must fulfil the inclusion criteria entirely, be willing and able to comply fully with the requirements of the study and be available to take part in the study.
    • Trial subjects must be found to be healthy in a physical examination before the study begins.
    • Trial subjects must sign the informed consent for participation in the study. Subjects will be informed about the nature, procedures, requirements, and restrictions of the trial. They will also be informed about risks, benefits/ compensation, and confidentiality (data protection), as well as about the voluntary nature of participation and whom to contact regarding questions or problems. Each subject willing to participate in the trial must sign and date an informed consent document, a copy of which will be given to the subject.
    E.4Principal exclusion criteria
    • Tension headache [32] more than once a month on average in the recent years.
    • All other primary forms of headache [32].
    • Painful or inflammatory diseases.
    • Raynaud’s phenomenon.
    • Systemic sclerosis or vasculitis.
    • Gastric ulcers or dyspepsia.
    • Gastrointestinal disease with possible influence on the uptake of medicine.
    • NSAID hypersensitivity.
    • Known allergy to the study drug constituents including lactose (incompatibility)
    • Intake of prescription or over-the-counter medicine within 14 days before the first study day. Daily intake of medicine of any kind except for an oral contraceptive.
    • Intake of any form of medicine later than 4 times the plasma half-life of the relevant substance (on the study day) apart from an oral contraceptive.
    • Vitamins, minerals and other nutritional supplements may be taken upon having notified the investigator of them.
    • Previous history with any relevant abnormal findings for kidney, liver, mental, neurological, respiratory, cardiovascular or gastrointestinal diseases.
    • Abnormal laboratory findings pointing to infectious, endocrinal, or other systemic diseases.
    • Trial subjects must not have abnormal ECG deviations within a period of 14 days before the first dose.
    • Pregnant or lactating women (negative urine HCG pregnancy test at screening)
    • Headache on the study day or within 24 hours before intake of the study medicine or placebo.
    • Trial subjects must not have clinically significant deviations in blood pressure or pulse within 14 days before the first dose.
    • Persons with systolic blood pressure elevation greater than 20 mmHg or pulse increased more than 20 beats per minute on changing from a supine to standing position.
    • Inclusion interview revealing medical history or clinical signs of:
    o hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg);
    o hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg).
    • Cardiovascular disease of any kind, including cerebrovascular disease.
    • Anamnestic or clinical signs of mental illness or substance abuse
    • Trial subjects not willing to limit alcohol intake to 2 units per day for 7 days before the first dose and to entirely abstain from alcohol consumption 2 days before the study days until the trial period is finished.
    • Trial subjects not willing to abstain from caffeine intake 2 days before the study and until the end of the study.
    • Incapacity to communicate properly with the investigator (due for example to speech difficulties, insufficient mental development, or reduced cerebral function).
    • Participation in a clinical study of a medicine without regulatory approval or marketing authorisation within 1 month before this trial.
    • Blood donation >500 ml within last 3 months.
    • Trial subjects subject to time changes and/or jet lag due to long distance travel or work in the night hours.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1
    Calculation of the number of trial subjects is based on the measurement of differences in pain intensity between treatments with reduction of pain in VRS at 5% significance limit with 90% power. It is assumed that each trial subject will show 20% variation in VRS. A 70% pain reduction will be considered to be of clinical significance.

    Phase 2
    Calculation of the sample size is based on detection of a difference between treatments in VMCA reduction at 5% significance (two-sided) with 80% power. It is assumed that each patient would show a 10% standard variation in VMCA. A true change in the dependent variables is considered 20%.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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 Yes
    F.3.2Patients No
    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 state14
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 14
    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 Decision2009-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-04-29
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