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    Summary
    EudraCT Number:2008-002560-34
    Sponsor's Protocol Code Number:F1J-US-HMFR(b)
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-07-29
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2008-002560-34
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of Duloxetine HCl in Patients with Central Neuropathic Pain Due to Multiple Sclerosis
    A.3.2Name or abbreviated title of the trial where available
    HMFR
    A.4.1Sponsor's protocol code numberF1J-US-HMFR(b)
    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 SponsorEli Lilly and Company
    B.1.3.4CountryUnited States
    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 Yes
    D.2.1.1.1Trade name Cymbalta
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly and Nederland B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDuloxetine
    D.3.2Product code LY248686
    D.3.4Pharmaceutical form Gastro-resistant 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 INNDULOXETINE
    D.3.9.1CAS number 116539594
    D.3.9.2Current sponsor codeLY248686
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 placeboGastro-resistant capsule, 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
    Central neuropathic pain due to Multiple sclerosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    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 efficacy of duloxetine 60 mg once daily (QD) compared with placebo on the reduction of central neuropathic pain severity as measured by the weekly mean of the daily 24-hour average pain scores in patients with central neuropathic pain due to MS assessed using an 11-point Likert scale and collected via daily patient diary at the end of 6 weeks of treatment.
    E.2.2Secondary objectives of the trial
    • To evaluate response to treatment with duloxetine versus placebo using 2
    response criteria, a 30% or 50% reduction, in the weekly 24-hour average pain scores described in the primary objective
    • To assess the efficacy of duloxetine versus placebo as measured by:PGI-Improvement scale,the weekly mean of the 24-hour worst, least, and night pain scores assessed using an 11-point Likert scale and collected via daily patient diary,BPI– Severity and Interference,CGI-Severity
    • To assess the impact of treatment with duloxetine versus
    placebo on patient-reported health outcomes, as measured by the MS-QOL-54
    • To assess the safety of duloxetine versus placebo treatment-emergent adverse events, discontinuation adverse events, solicited questioning of suicide-related events, and suicide risk as assessed the C-SSRS, laboratory assessments, and vital signs.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Protocol Addendum (1) 15 August 2008

    All patient enrolled in the clinical study F1J-US-HMFR will be invited to participate in
    this substudy. Patient participation in this substudy is optional. Eligible patients who
    choose to participate will consent to the collection and storage of blood for DNA
    extraction for research. DNA samples will be stored by the central laboratory located in the United States.
    Stored samples will retain the patient identifier and, therefore, will not be stored
    indefinitely. Samples will be stored for a maximum of 5 years after last patient visit for the study; any sample remaining at that time will be destroyed.
    Cells from stored samples will not be made to grow indefinitely in the laboratory
    (immortalized). In addition, the patient's entire genetic makeup will not be determined from the samples.
    The primary objective of this addendum is to collect and store sample(s) of whole blood for future research. The research on stored samples from this study will involve looking at genetic variants in DNA associated with pain in multiple sclerosis, depression, and treatment with duloxetine or other agents used to manage chronic pain. DNA samples may be analyzed for genetic variants (polymorphisms and/or single-nucleotide polymorphisms [SNPs]) that include, but are not limited to, the serotonin transporter (5-HTT), norepinephrine transporter (NET), adrenergic receptors, COMT and genes associated with drug metabolism and transport.

    Protocol Addendum (2) 4 December 2008 - Measurement of Plasma Levels of Brain-Derived Neurotrophic Factor (BDNF) Protocol Addendum

    All patient enrolled in the clinical study F1J-US-HMFR will be invited to participate in
    this substudy. Patient participation in this substudy is optional.
    The primary objective of this addendum is to collect plasma for assay of BDNF levels for research from subjects with central neuropathic pain due to MS treated with duloxetine or placebo and to determine via an exploratory secondary analysis whether pain reduction with study drug is correlated with changes in plasma levels of BDNF.
    The secondary objective is to evaluate via an exploratory secondary analysis the correlation between levels of BNDF and pain reduction with study drug in subjects with and without major depressive disorder.
    E.3Principal inclusion criteria
    [1] Present with central neuropathic pain due to MS based on the disease diagnostic criteria
    [2] Are male or female outpatients at least 18 years of age at the time of consent
    [3] Have a score of 4 or greater on the daily 24-hour average pain score (0-
    10) for at least 4 of the 7 days prior to Visit 2
    [4] Females must test negative for pregnancy at Visit 1. Females of childbearing potential must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study drug
    [5] Have an educational level and degree of understanding such that the patient can communicate intelligibly
    [6] Are judged to be reliable and agree to keep all appointments for clinic
    visits, tests, and procedures required by the protocol
    [7] Complete the daily diaries for at least 70% of the days between Visit 1 and Visit 2
    [8] Patients may continue other prescription and non-prescription analgesic
    medications as long as the dose has been stable for 1 month prior to
    Visit 1, and they agree to maintain that stable dose throughout the study. Patients will NOT be allowed to change doses of concomitant analgesics
    during the study
    [9] Diagnosis of MS at least 1 year prior to Visit 1 as determined by MacDonald or Poser criteria.
    [10] Clinical stability as determined by an absence of MS exacerbation or
    change in disease modifying therapy for the 3 months prior to Visit 1.
    [11] Daily central neuropathic pain due to MS present for a minimum of 3 months prior to Visit 1
    E.4Principal exclusion criteria
    [12] Are investigator site personnel directly affiliated with this study and/or their immediate families
    [13] Are Lilly employees
    [14] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
    [15] Are currently in a clinical trial of MS disease-modifying therapy
    [16] Have pain that cannot be clearly differentiated from causes other than MS
    [17] Have previously completed this study, withdrawn from any duloxetine study, or have been intolerant to previous duloxetine treatment. Note: Patients who have screen-failed for the reason of previous exposure to duloxetine may be reconsidered for this study.
    [18] Have previously demonstrated lack of response to an adequate trial of duloxetine per investigator opinion.
    [19] Are unwilling to comply with the use of a data collection device to directly record data from the patient. For those patients who do not have enough fine motor control to enter data directly into the device, a designated assistant may be used for data entry. The assistant must be the same person for all data entries. The designated assistant may not be site personnel or personnel affiliated with the study.
    [20] Any current or historical DSM-IV diagnosis of mania, bipolar disorder, psychosis, or schizoaffective disorder
    [21] History of DSM-IV-TR substance abuse or dependence within the 6
    months immediately prior to Visit 1, excluding nicotine and caffeine. For purposes of this study, prior or current use (at Visit 1) of dronabinol (Saltivex) for MS or MS pain will not be considered to meet the DSm-IV criteria for substance abuse. However, use of this medication may be subject to other restrictions (see concomitant medication list for excluded medications).
    [22] Are taking any excluded medications that cannot be discontinued at
    Visit 1 (see concomitant medication list for excluded medications).
    [23] Have had treatment with a MAOI within 14 days of randomization or
    the potential need to use an MAOI during the study or within 5 days of
    discontinuation of study drug
    [24] Have a positive urine drug screen for any substance of abuse or excluded
    medication
    [25] Are pregnant or breast-feeding
    [26] Have serious cardiovascular, hepatic, renal, respiratory, or hematologic
    illness, or other medical or psychiatric condition that, in the opinion of
    the investigator, would compromise participation or be likely to lead to
    hospitalization during the course of the study.
    [27] Have elective surgery planned during the trial.
    [28] Have a history of recurrent seizures other than febrile seizures.
    [29] Are judged clinically by the investigator or are identified by the C-SSRS or BDI-II question 9 to be at suicidal risk prior to starting study drug. Patients will need to be evaluated by the investigator and/or a psychiatrist if they exhibit suicidality as assessed by the C-SSRS or BDI-II question 9 at any time after randomization.
    [30] Have uncontrolled narrow-angle glaucoma.
    [31] Have acute liver injury or severe cirrhosis
    [32] Have known hypersensitivity to duloxetine or any of the inactive ingredients
    [33] Have frequent or severe allergic reactions to multiple medications
    [34] Current DSM-IV-TR Axis I alcohol or eating disorders or PTSD as determined either by patient history or by diagnosis using specific modules of the MINI
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure is the weekly mean of the 24-hour average pain severity assessed daily by each patient, via daily diary, using an 11-point Likert scale.
    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 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) 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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 months17
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months17
    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 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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 238
    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 Decision2008-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-02
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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