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    Summary
    EudraCT Number:2006-006100-11
    Sponsor's Protocol Code Number:203818-503
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-28
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-006100-11
    A.3Full title of the trial
    A multicenter, multiple dose, double-blind, randomized, placebo-controlled, parallel group study of the safety and efficacy of AGN 203818 in female patients with fibromyalgia syndrome.
    A.4.1Sponsor's protocol code number203818-503
    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 SponsorAllergan Ltd
    B.1.3.4CountryUnited Kingdom
    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 nameAGN 203818
    D.3.2Product code 9697X
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN(+)-4-(S)-[1-(2,3-Dimethyl-phenyl)-ethyl]-1,3-dihydro-imidazole-2-thione
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeAGN 203818
    D.3.9.3Other descriptive name(S)-4-{2,3-Dimethylphentl)-ethyl}-2-thiono-1,3-dihydro-1H-imidazole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20 capsules to per bottle
    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.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.3.1Product nameAGN 203818
    D.3.2Product code 9784X
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN(+)-4-(S)-[1-(2,3-Dimethyl-phenyl)-ethyl]-1,3-dihydro-imidazole-2-thione
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeAGN 203818
    D.3.9.3Other descriptive name(S)-4-{2,3-Dimethylphentl)-ethyl}-2-thiono-1,3-dihydro-1H-imidazole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20 capsules to per bottle
    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.IMP: 3
    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 nameAGN 203818
    D.3.2Product code 9698X
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN(+)-4-(S)-[1-(2,3-Dimethyl-phenyl)-ethyl]-1,3-dihydro-imidazole-2-thione
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeAGN 203818
    D.3.9.3Other descriptive name(S)-4-{2,3-Dimethylphentl)-ethyl}-2-thiono-1,3-dihydro-1H-imidazole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20 capsules to per bottle
    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
    Fibromyalgia syndrome in female patients
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10016631
    E.1.2Term Fibromyalgia syndrome
    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 safety and efficacy of AGN 203818 oral capsules administered twice-daily as compared with placebo in female patients with fibromyalgia syndrome.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Written informed consent and data protection consent has been obtained.
    - Female patients 18 to 75.
    - Patient has fibromyalgia syndrome (FMS) as defined by the American College of Rheumatatology (1990) criteria.
    - FMS is the patient's primary painful condition.
    - Patient has pain associated with FMS defined according to the 11 point Likert scale.
    - WOCBP must have a negative pregnancy test at screening.
    - Patient is acceptable for enrollment as determined by the investigator from the screening procedures.
    - Patient must be able to understand and co-operate with the study requirements and instructions and be willing and able to complete all study visits.
    E.4Principal exclusion criteria
    - Anticipated change or recent initiation of pharmacological or non-pharmacological therapies for FMS.
    - Use of any prohibited medications prior to baseline visit.
    - Patient using herbal supplements and not on a stable and regular dose for at least 4 weeks prior to baseline.
    - Uncontrolled concurrent disease other than FMS.
    - Positive test for hepatitis B, hepatitis C or HIV virus antibodies at screening.
    - Thyroid function test results that are considered unacceptable.
    - Thyroidectomy or radio-iodine therapy for hyperthyroidism with 12 months of baseline.
    - History of rheumatoid arthritis, inflammatory arthritis, autoimmune disease associated with pain or other significant painful conditions that may confound the study.
    - Previous or current diagnosis of manic or hypomanic episode (bipolar disorder) or psychotic disorder, including current or lifetime diagnosis of these diagnostic categories identified by the Mini- International Neuropsychiatric Interview (MINI)
    - Current diagnosis of a major depressive episode, dysthymic disorder, or generalised anxiety disorder irrespective of whether the disorder is currently controlled by pharmacological treatment, including any of the above listed diagnostic categories or a moderate or high suicidal risk, identified by the MINI, or at risk of self-harm.
    - Score greater than or equal to 2 on question 9 (suicide) of the Beck Depression Inventory at baseline, or at risk of self-harm.
    - Clinically significant hypotension (including symptomatic orthostatic).
    - History of significant allergic condition including severe drug-related hypersensitivity (e.g. anaphylactic reaction)
    - Known allergy or sensitivity to any compound or chemical class related to AGN 203818 or its excipients.
    - Previously participated in an AGN 203818 study.
    - History of treatment for or evidence of alcohol or drug abuse within the past year or regular alcohol consumption exceeding an average of 2 units per day.
    - Current enrollment in another IP or device study.
    - WOCP who is not using a double-barrier method of contraception.
    - Pregnancy, nursing, or planning a pregnancy.
    - Anticipated need for surgery or hospitalisation during the study.
    - Currently applying for disability allowance or have ongoing litigation activities related to their medical condition.
    - A condition or situation which may put the patient at significant risk, may confound the study results or interfere significantly with participation.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy measurement:
    - Daily-average-pain score (11 Likert Scale) from the patient diary.

    Secondary efficacy measures:
    - Daily-worst-pain score (11 point Likert Scale) from the patient diary.
    - Incidence of responders by various percentages of reduction from baseline in mean daily-average-pain-score.
    - Short Form Brief Pain Inventory and Short Form McGill Pain questionnaire
    - Use of rescue medication for pain associated with FMS
    - 18 point Dolorimetry measurement to provide mean pressure pain threshold and tenderpoint count.
    - Fibromyalgia Impact Questionnaire.
    - Subject Global Impression of Change for FMS.
    - Medical Outcome Study Sleep scale and Jenkins Sleep Evaluation Questionnaire.
    - Daily-sleep-interference score (11 point Likert Scale).
    - Multidimensional Assessment of Fatigue and daily-fatigue-score (11 point Likert).
    - Beck Depression and Anxiety Inventory and Profile of Mood States.
    - SF-36 Health Surveys and Work Productivity and Activity Impairment Questionnaire.
    - For migraine sufferers a Subject Global assessment of Change for headache severity and frequency and duration.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Genotyping
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 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) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 160
    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)
    Standard treatment will be resumed
    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 Decision2007-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-10-27
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