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    Summary
    EudraCT Number:2006-001230-41
    Sponsor's Protocol Code Number:F02207GE304
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-06-01
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-001230-41
    A.3Full title of the trial
    A EUROPEAN PHASE III, MULTICENTRE, DOUBLE-BLIND, RANDOMISED, MONOTHERAPY, 12-MONTH STUDY OF MILNACIPRAN FOR THE TREATMENT OF THE FIBROMYALGIA SYNDROME
    A.3.2Name or abbreviated title of the trial where available
    FMS European Long-Term Study
    A.4.1Sponsor's protocol code numberF02207GE304
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorPIERRE FABRE MEDICAMENT
    B.1.3.4CountryFrance
    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 nameMilnacipran 25mg
    D.3.2Product code F2207
    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.3.8INN - Proposed INNMilnacipran
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Fibromyalgia Syndrome
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10048439
    E.1.2Term Fibromyalgia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the long-term safety of milnacipran used for the tratment of FMS at doses of 100, 150 and 200 mg daily.
    E.2.2Secondary objectives of the trial
    To investigate the logn-term efficacy (including the durability of efficacy)of milnacipran in treating FMS over 12 months of exposure at doses of 100, 150 and 200 mg daily.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    In order to be eligible to participate in the study, the Patient must fulfil the following criteria: ﾕ Has completed the 3-month F02207 GE 3 02 study, ﾕ Is able to give and has given her/his informed consent, ﾕ Is able to perform the Screening Visit (V1) on the day of F02207 GE 3 02 last visit (V10), ﾕ Had a diagnosis of FMS according to the American College of Rheumatology (ACR) 1990 at entry of F02207 GE3 02 study, ﾕ Is a male or female patient between the ages of 18 and 71 years, ﾕ (for women) Is either postmenopausal (no menses for at least 1 year) or has a post-hysterectomy, -oophorectomy (bilateral), or -tubal ligation status or, if of childbearing potential, has a negative urine pregnancy test at inclusion (V2/D1), and is currently using a medically acceptable form of contraception (e.g., hormonal birth control, IUD, double barrier [male condom, female condom, diaphragm] or a barrier method plus a spermicidal agent [contraceptive foam, jelly, or cream]). The Patient should be advised to continue the contraception one month (or two months for Denmark) after the intake of the last dose of study treatment, ﾕ Has a BDI &#61603; 25 and BDI-item 9 &#61603;1 at Screening (V1/D-7) and Inclusion (V2/D1), ﾕ Is willing to carry on with withdrawal from CNS-active therapies commonly used for FMS, including anti-depressants, anti-convulsants, opioids whatever the route of administration, ﾕ Is willing to carry on with withdrawal from trigger point and tender point injections, acupuncture, and anaesthetics (ketamine).
    E.4Principal exclusion criteria
    Psychological/ Psychiatric Criteria ﾕ With a major depressive episode, significant risk of suicide (ﾓmoderateﾔ or ﾓhighﾔ) or generalised anxiety disorder (GAD) at inclusion (V2/D1) according to the MINI (modules A, C and O) performed by a trained staff at Inclusion (V2/D1), ﾕ With a positive urine drug screen for benzodiazepines, opiates and cannabis at Screening (V1), ﾕ With a history or behaviour that would, in the Investigatorﾒs opinion, prohibit compliance for the duration of the study. Somatic Criteria ﾕ With, within the past 6 months, a clinically significant cardiac disease on routine clinical examination (history, physical examination and ECG recording), or known congestive heart failure, myocardial infarction, clinically significant valvular heart disease (including patients with a prosthetic heart valve), and/or clinically significant cardiac rhythm or conduction abnormalities, and/or uncontrolled or unstable hypertension. ﾕ With pulmonary dysfunction or severe obstructive pulmonary disease that, in the Investigatorﾒs judgment, could interfere with the study participation and completion. ﾕ With evidence of active liver disease (levels of AST, ALT and/or alkaline phosphatase > 1.5 x the upper limit of the normal range for the laboratory performing the test) or with a clinically significant laboratory abnormality. ﾕ With renal impairment (Cockroft creatinine clearance < 60 ml/min: adjustment for patient gender, age and weight). ﾕ With suspected rheumatoid arthritis or any other systemic autoimmune disease. ﾕ With current systemic infection. ﾕ Epileptic ﾕ With active cancer, (except basal cell carcinoma), or patients currently undergoing therapy for cancer. ﾕ With a current life expectancy less than one year. ﾕ With sleep apnoea severe enough that, in the Investigatorﾒs opinion, would interfere with interpretation of changes in sleep habits. ﾕ With active peptic ulcer, inflammatory bowel disease. ﾕ With unstable endocrine disease, including unstable diabetes or thyroid disease. Disorders that have been stable under treatment for the preceding 6 months before inclusion will be acceptable. ﾕ (for men) With prostatic enlargement or other genito-urinary disorders, that might be at significant risk of dysuria and/or urinary retention when taking agents with noradrenaline re-uptake inhibition properties. ﾕ (for women) Pregnant or breastfeeding. Treatment-related Criteria ﾕ With a known hypersensitivity to milnacipran, ﾕ Has been receiving between screening and inclusion: ﾕ MAO-A or -B inhibitors, tricyclics, tetracyclics, SSRIs agents, NARIs agents, SNRIs agents or alpha-agonists, anticonvulsants (phenytoine), phytotherapy with anxiolytic or anti-drepressive properties (e.g., hypericum), dopamine agonists, cholinesterase inhibitors (pyridostigmine, ambemonium) or muscle relaxants, ﾕ phenytoin and phenobarbital, oral anticoagulants (warfarin), carbamazepine and levomepromazine, ﾕ epinephrine, norepinephrine (alpha and beta sympathomimetics), ﾕ SAMe, melatonine or DHEA, ﾕ digitalis (digoxin) preparations, ﾕ centrally-acting class III analgesics, ﾕ trigger point and tender point injections, acupuncture, and anaesthetics (ketamine) ﾕ Has been receiving statines, except if stable, within 4 weeks before inclusion, ﾕ Is receiving concomitant therapy with long-term systemic corticosteroids except if stable and at low doses (equivalent to 10 mg of cortisone).
    E.5 End points
    E.5.1Primary end point(s)
    Safety: Continuous adverse events report, - Vital signs, physical examination, weight at each scheduled and unscheduled visits, - ECG and clinical laboratory dat at Screening Visit, End-of-Escalation Visit (V3/W4), V7/W28 and V10/W52 or PW (end of target dose phase)visits Efficacy: - At each scheduled and unscheduled visit (from inclusion): - Last Week Pain VAS, last 24h Pain VAS, Current Pain VAS and Patien Global Impression of Change (PGIC), - Last week sleep quality VAS and last week ovarall fatigue VAS. At each scheduled visit: - Brief Pain Inventory Short Form (BPI-SF), State Trait Anxiety Inventory (STAI-S), - Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI), At W0, W28, Week 52 (or PW) and Week 56: - Multi-dimentional Fatigue Inventory (MFI), Health Status (SF36), Multiple Ability Self-Report Questionnaire (MASQ). Specific Baseline Characteristics: - A, C, O MINI modules at V2.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 years2
    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 years2
    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) Yes
    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 Information not present in EudraCT
    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 2007-06-01. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 420
    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 Decision2006-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-10-02
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