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    Summary
    EudraCT Number:2019-000702-30
    Sponsor's Protocol Code Number:18.021
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-08-23
    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 number2019-000702-30
    A.3Full title of the trial
    Fibromyalgia and Naltrexone: The FINAL study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fibromyalgia and Naltrexone: The FINAL study
    A.3.2Name or abbreviated title of the trial where available
    FINAL
    A.4.1Sponsor's protocol code number18.021
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOdense University Hospital
    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 supportUniversity of southern Denmark
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRegion of southern Denmark
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Danish Rheumatism Association
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOdense University Hospital
    B.5.2Functional name of contact pointPain centre
    B.5.3 Address:
    B.5.3.1Street AddressHeden 7-9
    B.5.3.2Town/ cityOdense
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    B.5.6E-mailkplesner@health.sdu.dk
    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 Naltrexone
    D.2.1.1.2Name of the Marketing Authorisation holderPOA Pharma Scandinavia AB
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNNaltrexone hydrochloride
    D.3.9.3Other descriptive nameNALTREXONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB14629MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboTablet
    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
    E.1.1.1Medical condition in easily understood language
    Fibromyalgia
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10048439
    E.1.2Term Fibromyalgia
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the trial is to investigate whether treatment with Low dose Naltrexone (LDN) has a superior effect compared with placebo on pain in female patients with fibromyalgia, evaluated after 12 weeks of treatment.
    E.2.2Secondary objectives of the trial
    Our key secondary efficacy objectives will be to compare the effect of drug LDN, relative to placebo, on (i) global assessment and on (ii) changes in pain, (iii) tenderness, (iv) fatigue, (v) sleep disturbance, (vi) depression, (vii) anxiety, (viii) cognition, (ix) stiffness, (x) physical function, (xi) quality of life and (xii) pain distribution from baseline to week 4, 8 and 12, in female patients with fibromyalgia. Furthermore, responder indices will be compared between the treatment groups.

    Among the exploratory secondary objectives are changes in muscle exhaustion, physical fitness, pain sensitivity, inhibition of pain, augmentation of pain, and pro- or anti-inflammatory cytokines.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Women aged 18-64 years
    - Understands and writes Danish
    - Fulfills the ACR1990 criteria for fibromyalgia
    - A minimum score of 4 in self-reported average pain during the last 7 days on a 0-10 NRS at baseline
    - All fertile women have to use safe anti conception
    E.4Principal exclusion criteria
    - Known allergy against naltrexonehydroclorid
    - Pregnancy or breastfeeding. A negative pregnancy test has to be available for all fertile subjects at baseline
    - Use of opioids or NSAIDs up to 4 weeks before inclusion in the trial
    - Abuse of alcohol or other substances
    - Inflammatory rheumatic diseases
    - Demyelinating diseases
    - Active cancer
    - Liver dysfunction (ALAT must not be elevated more than 2-fold over highest reference level)
    - Kidney dysfunction (GFR < 59 mL/min)
    - Psychotic diseases
    - History of suicide attempts
    - Suicide ideation – evaluated using PHQ-9 (Item 9 has to be answered “never”)
    E.5 End points
    E.5.1Primary end point(s)
    Average pain during the last 7 days. Change from baseline when assessed after 12 weeks of treatment with LDN or LDN-placebo.
    Assessed by asking the participants about the level of average pain during the last 7 days on a 11 point rating scale, ranging from 0-10 (0 = "no pain" and 10 = "unbearable pain") using the first item from the symptom part of the Fibromyalgia Impact Questionnaire Revised.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 12 weeks of treatment
    E.5.2Secondary end point(s)
    The secondary outcomes include 21 supportive measures that will be collected, analyzed and reported in the primary manuscript.

    For the following secondary outcomes, the between-group change at baseline compared to 4, 8 and 12 weeks of treatment is assessed:
    1. Global assessment. Assessed by Patient Global Impression of Change on a 1-7 Verbal Rating Scale.
    2. Impact of fibromyalgia. Assessed by the FIQR total score (22).
    3. Pain distribution. Assessed by the Widespread Pain Index (WPI) from the 2016 diagnostic criteria for fibromyalgia (23).
    4. Level of pain (assessment of pain intensity trajectory). Assessed by the FIQR "level of pain" question.
    5. Level of tenderness. Assessed subjectively by the FIQR "level of tenderness to touch" question and assessed objectively by measurement of pressure pain threshold, using a handheld algometer.
    6. Level of fatigue. Assessed by the FIQR "level of energy" question.
    7. Level of sleep disturbance. Assessed by the FIQR "quality of sleep" question.
    8. Level of depression. Assessed by the FIQR "level of depression" question.
    9. Level of anxiety. Assessed by the FIQR "level of anxiety" question.
    10. Level of cognition. Assessed by the FIQR "level of memory problems" question.
    11. Level of stiffness. Assessed by the FIQR "level of stiffness" question.
    12. Level of physical function. Assessed by the physical function domain of FIQR.
    13. Health-related quality of life – mobility. Assessed by the European Quality of Life 5 Dimensions (EQ-5D) mobility domain.
    14. Health-related quality of life - self-care. Assessed by the EQ-5D self-care domain.
    15. Health-related quality of life - usual activities. Assessed by the EQ-5D usual activities domain.
    16. Health-related quality of life - pain/discomfort. Assessed by the EQ-5D pain/discomfort domain.
    17. Health-related quality of life - anxiety/depression. Assessed by the EQ-5D anxiety/depression domain.
    18. Health-related quality of life – global. Assessed by European Quality of Life Visual Analogue Scale (EQ-VAS).

    Responder indices:
    19. Number of responders with a more than 15% improvement of the primary outcome.
    20. Number of responders with a more than 30% improvement of the primary outcome.
    21. Number of responders with a more than 50% improvement of the primary outcome.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 4, 8, and 12 weeks of treatment

    Responder indices after 12 weeks of treatment
    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.8.2.4Number of treatment arms in the trial2
    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 No
    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
    Last visit - last subject
    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 days0
    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.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state100
    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)
    Subjects are offered standard treatment for fibromyalgia after end of the trial
    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 Decision2019-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-12-27
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