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    Summary
    EudraCT Number:2006-001488-51
    Sponsor's Protocol Code Number:ADX10059-201
    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:2006-06-01
    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 number2006-001488-51
    A.3Full title of the trial
    A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY, TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF THE MGLUR5 NEGATIVE ALLOSTERIC MODULATOR ADX10059 IN THE ACUTE TREATMENT OF MIGRAINE
    A.4.1Sponsor's protocol code numberADX10059-201
    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 SponsorAddex Pharmaceuticals S.A.
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    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.3.1Product nameADX10059
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeADX10059
    D.3.9.3Other descriptive name(2-(3-Fluorophenylethynyl)-4,6-dimethyl-pyridin-3-yl)amine citrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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, hard
    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
    Migraine with or without aura
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10027599
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary study objective is to evaluate the efficacy of oral ADX10059 in the acute treatment of moderate or severe migraine headache pain.
    E.2.2Secondary objectives of the trial
    As secondary parameters, the safety and tolerability of an oral administration of ADX10059 when taken by migraine patients and its efficacy in treating the accompanying non-headache symptoms of migraine will be evaluated.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female and male patients aged 18 to 65 years.
    2. Diagnosis of migraine with or without aura according to IHS criteria 1.1 and 1.2.1
    3. Onset of migraine history prior to age 50 years
    4. Patients who have between 2 and 8 moderate or severe migraine headaches per month.
    5. Ability to communicate well with the study staff and to comply with the requirements of the entire study.
    6. Patients who have provided written informed consent to participate in this study.
    E.4Principal exclusion criteria
    1. Administration of any investigational drug up to 30 days before study entry or parallel participation in another study
    2. Patients with more than 15 headache days per month.
    3. Patients with known clinically significant allergy or known hypersensitivity to ADX10059 or lactose.
    4. Patients who have abnormal laboratory parameters at screening, in particular, liver or renal functions tests greater than twice the upper limit of normal or any other clinically significant biochemical or hematological abnormality as determined by the investigator.
    5. Patients with a history of a significant medical or psychiatric condition that may affect the safety of the patient or preclude adequate participation in the study.
    6. Patients who are pregnant or breast-feeding. Female patients who are of child bearing potential must be using adequate contraceptive methods (e.g. oral contraceptives, intra uterine device (IUD), double barrier method (e.g. spermicide plus condom or diaphragm plus spermicide) and intra muscular hormonal contraceptive).
    7. Patients using migraine prophylaxis must have been on stable doses of the prophylactic agent for least 12 weeks prior to study entry.
    8. Patients taking sodium valproate or valproic acid or patients who have taken either of these within the last 30 days.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    · Proportion of patients with initial moderate or severe (IHS Grade 2/3) pain who become pain free (IHS Grade 0) 2 hours after dosing.

    Secondary endpoints:

    · Proportion of patients pain free (Grade 0 headache) 30 min., 1, 1.5, 3, 4 and 24 hours post dosing.
    · Proportion of patients with Grade 1 or 0 headache (pain relief) 30 min., 1, 1.5, 2, 3, 4 and 24 hours post dosing.
    · Actual (wristwatch) time to pain free (Grade 0 headache) following dosing.
    · 24-hour headache recurrence defined as the proportion of patients with Grade 0 headache at 2 hours post dose with a return to Grade 2/3 headache or Grade 1 headache that requires rescue medication in the subsequent 22 hours.
    · Actual (wristwatch) time of headache recurrence.
    · Sustained pain free response (patients with Grade 0 headache at 2 hours and no headache recurrence within 24 hours post dosing).
    · Sustained headache response (patients with Grade 1/0 headache at 2 hours and no headache recurrence (Grade 2/3) within 24 hours post dosing.
    · Severity of functional impairment 30 min., 1, 1.5, 2, 3, 4 and 24 hours post dosing.
    · Presence of nausea, vomiting, photophobia and phonophobia at 30 min., 1, 1.5, 2, 3, 4 and 24 hours post dosing.
    · Proportions of patients using rescue medication.
    · Subjective evaluation of study medication by patient
    · Time to meaningful relief of the overall migraine attack.
    · Incidence and severity of adverse events.
    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 No
    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 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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    The end of the study is defined as the last visit of the last patient in the country where the last patient has his/her final visit.
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months5
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-06-01. Yes
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    There is no provision of further treatment after end of the trial. The patients will return to their physician and will be treated with standard therapy, if indicated.
    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 Decision2006-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-12-20
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