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    Summary
    EudraCT Number:2013-005164-26
    Sponsor's Protocol Code Number:DS5565-A-E312
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-11-25
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2013-005164-26
    A.3Full title of the trial
    An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated with Fibromyalgia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 52 week clinical trial with the test compound DS-5565, in patients who suffer from pain related to fibromyalgia
    A.4.1Sponsor's protocol code numberDS5565-A-E312
    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 SponsorDaiichi Sankyo Development 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 supportDaiichi Sankyo Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo Development Ltd
    B.5.2Functional name of contact pointClinical Trial Application
    B.5.3 Address:
    B.5.3.1Street AddressChiltern Place, Chalfont Park
    B.5.3.2Town/ cityGerrards Cross, Buckinghamshire
    B.5.3.3Post codeSL9 0BG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441753482800
    B.5.5Fax number+441753899107
    B.5.6E-maileuregaffairs@dsd-eu.com
    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 nameDS-5565
    D.3.2Product code DS-5565
    D.3.4Pharmaceutical form Film-coated 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 INNMirogabalin
    D.3.9.2Current sponsor codeDS-5565
    D.3.9.3Other descriptive nameDS-5565
    D.3.9.4EV Substance CodeSUB60040
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    DS-5565 is being developed for the treatment of pain associated with fibromyalgia (FM).
    E.1.1.1Medical condition in easily understood language
    Treatment of pain related to fibromyalgia
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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
    To assess the long-term safety of DS-5565 in subjects with FM
    E.2.2Secondary objectives of the trial
    • To observe the effects of DS-5565 on average daily pain score (ADPS) and pain-associated average daily sleep interference score (ADSIS) (both recorded in a diary). Weekly ADPS is based on daily pain scores reported by the subject that best describes his or her worst pain over the previous 24 hours.
    • To observe the effects of DS-5565 on Patient Global Impression of Change (PGIC)
    • To observe the effects of DS-5565 on depression and anxiety as assessed by the Hospital Anxiety and Depression Scale (HADS)
    • To observe the effects of DS-5565 on subject quality of life as assessed by the EuroQoL Instrument 5 Domains (EQ-5D) and the Short Form 36 (SF-36).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who completed one of the preceding Phase 3 DS-5565 study (DS5565-A-E309, DS5565-A-E310, or DS5565-A-E311):
    1. Able to give written informed consent
    2. Completed participation (i.e. completed the End-of-Tapering visit) in a preceding study of DS-5565 in FM (DS5565-A-E309, DS5565-A-E310, or DS5565-A-E311)
    3. Women of child-bearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy during the study and for 4 weeks after study completion
    4. The subject must not have experienced any significant safety issues during the preceding study that, in the investigator’s judgment, would adversely impact the subject’s well-being in the long-term extension

    De Novo Subjects:
    5. Age ≥ 18 years
    6. Able to give written informed consent
    7. Able to complete subject-reported questionnaires per the investigator’s judgment
    8. At screening, subjects must meet the 1990 American College of Rheumatology (ACR) criteria for FM, i.e. widespread pain present for at least 3 months and pain in at least 11 of 18 specific tender point sites. In addition, the 2010 ACR criteria must be met:
    • Widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5, or WPI 3 to 6 and SS scale score ≥ 9
    • Symptoms have been present at a similar level for at least 3 months
    • The subject does not have a disorder that would otherwise explain the pain
    9. ADPS of ≥ 4 on the 11-point numeric rating scale (NRS) over the past 7 days prior to first dose (based on completion of at least 4 daily pain diaries during the 7-day baseline period)
    10. Subject must have documented evidence of a fundoscopic examination (with pupil dilation) or a scanning laser ophthalmoscopy examination within 12 months prior to screening or at screening
    11. Women of child-bearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy during the study and for 4 weeks after study completion
    E.4Principal exclusion criteria
    All Subjects:
    1. Clinically significant unstable neurologic, psychiatric, ophthalmologic, hepatobiliary, respiratory, or hematologic illness or unstable cardiovascular disease (e.g. severe hypotension, uncontrolled cardiac arrhythmia, or myocardial infarction) or any other concurrent disease during the preceding study (for rollover subjects) or within 12 months prior to screening (for de novo subjects) that in the opinion of the investigator would interfere with study participation or assessment of safety and tolerability
    2. Subjects who are at risk of suicide as defined by their responses to the Columbia-Suicide Severity Rating Scale (C-SSRS) or in the opinion of the investigator. Note: Subjects answering “yes” to any of the questions about active suicidal ideation/intent/behaviors occurring within the past 12 months must be excluded (C-SSRS Suicide Ideation section – Questions 3, 4, or 5; C-SSRS Suicidal Behavior section, any of the suicide behaviors questions). Such subjects should be referred immediately to a mental health professional for appropriate evaluation.
    3. Subjects who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the investigator to be unlikely to complete the study
    4. Subjects with severe or uncontrolled depression that, in the judgment of the investigator, makes the subject inappropriate for entry into the study
    5. Subjects with pain due to other conditions (e.g. diabetic peripheral neuropathic pain or post-herpetic neuralgia) that, in the opinion of the investigator, would confound assessment or self-evaluation of the pain associated with FM
    6. Subjects with pain due to any widespread inflammatory musculoskeletal disorder (e.g. rheumatoid arthritis, lupus) or widespread rheumatic disease other than FM.
    7. Abuse or dependence of prescription medications, street drugs, or alcohol within the last 1 year
    8. Any history of a malignancy other than basal cell carcinoma within the past 5 years
    9. A diagnosis of untreated sleep apnea or initiation of treatment for sleep apnea within the past 3 months
    10. Known hypersensitivity to α2δ ligands or other components of the study medications
    11. Pregnancy or breast-feeding, or intent to become pregnant during the study period
    12. Abnormal investigative tests (i.e. ECGs) and laboratory values judged by the investigator to be clinically significant at the End-of-Treatment visit (Visit 11, Week 13) in the preceding study (for rollover subjects) or at screening (for de novo subjects), with particular focus on:
    • Abnormal renal function defined as calculated CrCl < 60 mL/min determined by the central laboratory using the Cockcroft-Gault equation(4); blood urea nitrogen> 1.5 × ULN; serum creatinine > 1.6 mg/dL (> 141.4 μmol/L); or
    • Abnormal liver function defined as AST (SGOT) > 2.0 × ULN, ALT (SGPT) > 2.0 × ULN; alkaline phosphatase > 1.5 × ULN; total bilirubin> 1.2 × ULN. If a subject has total bilirubin > 1.2 ULN, unconjugated and conjugated bilirubin fractions should be analyzed and only subjects documented to have Gilbert’s syndrome may be enrolled; or
    • Creatine kinase> 3.0 × ULN;

    For De Novo Subjects Only:
    13. Unable to undergo pre-study washout of prohibited concomitant medications
    14. Current severe or uncontrolled major depressive disorder or anxiety disorders as assessed by the Mini-international Neuropsychiatric Interview (MINI) interview (Version 6.0) at screening are excluded, but mild to moderate major depression or anxiety disorders are permitted provided that the investigator assesses the patient as clinically stable and appropriate for entry into the study
    15. Any diagnosis of lifetime bipolar disorder or psychotic disorder
    16. Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study or is receiving other investigational agents
    17. Subject is an employee of the study center, an immediate family member* of an employee of the study center, or an employee of Daiichi Sankyo, INC Research, or any of the study vendors supporting this study. *(spouse, parent, child, or sibling, whether biological or legally adopted)
    E.5 End points
    E.5.1Primary end point(s)
    Long-term safety based on assessment of treatment-emergent adverse events (TEAEs), clinical laboratory evaluations, physical examinations, electrocardiograms (ECGs), the Columbia-Suicide Severity Rating Scale (C-SSRS), and the Physician Withdrawal Checklist (PWC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    from the screening/baseline visit to
    the end of treatment visit (ECGs) / end of the follow-up visit (TEAEs, C-SSRS, PWC) / early termination visit
    E.5.2Secondary end point(s)
    • Changes from baseline to scheduled timepoint in ADPS and ADSIS
    • Proportion of subjects with improvement in overall status at Week 52 as assessed by PGIC
    • Changes from baseline to Week 52 in HADS depression and anxiety scores
    • Changes in EQ-5D and SF-36 parameters from baseline to Week 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Changes from baseline to scheduled timepoint in ADPS and ADSIS:
    from baseline visit to end of treatment (Week 52)/early termination visit
    • Proportion of subjects with improvement in overall status at Week 52 as assessed by PGIC:
    at end of treatment (Week 52)/early termination visit
    • Changes from baseline to Week 52 in HADS depression and anxiety scores:
    from baseline visit to end of treatment (Week 52)/early termination visit
    • Changes in EQ-5D or SF-36 parameters from baseline to Week 52:
    from baseline visit to end of treatment (Week 52)/early termination visit
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA268
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belarus
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Croatia
    Czech Republic
    Denmark
    Estonia
    Finland
    France
    Georgia
    Germany
    Hungary
    India
    Israel
    Italy
    Latvia
    Lithuania
    Mexico
    Netherlands
    New Zealand
    Norway
    Poland
    Portugal
    Puerto Rico
    Romania
    Russian Federation
    Serbia
    Slovakia
    Slovenia
    South Africa
    Spain
    Sweden
    Switzerland
    Turkey
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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: 924
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 231
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 277
    F.4.2.2In the whole clinical trial 1155
    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)
    none
    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 Decision2015-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-19
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