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    Summary
    EudraCT Number:2014-003972-21
    Sponsor's Protocol Code Number:DS5565-A-U307
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-03
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2014-003972-21
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED SAFETY STUDY OF DS-5565 FOR TREATMENT OF PAIN DUE TO FIBROMYALGIA IN SUBJECTS WITH CHRONIC KIDNEY DISEASE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial which compares the safety of a not yet approved drug called DS-5565 versus placebo, in patients with pain related to fibromyalgia who also suffer from chronic kidney disease
    A.4.1Sponsor's protocol code numberDS5565-A-U307
    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, Inc.
    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 supportDaiichi Sankyo, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo, Inc.
    B.5.2Functional name of contact pointClinical Trial Information Contact
    B.5.3 Address:
    B.5.3.1Street Address399 Thornall Street
    B.5.3.2Town/ cityEdison
    B.5.3.3Post codeNJ 08837
    B.5.3.4CountryUnited States
    B.5.4Telephone number001732590 5000
    B.5.5Fax number001732906 5690
    B.5.6E-maileu_cta@dsi.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 number7.5
    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 placeboFilm-coated tablet
    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
    DS-5565 is being investigated for the treatment of pain associated with fibromyalgia (FM) in subjects with chronic kidney disease.
    E.1.1.1Medical condition in easily understood language
    Treatment of pain related to fibromyalgia in patients with kidney disease.
    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 19.1
    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 determine the safety and tolerability of subjects with FM and moderate to severe renal dysfunction during 13 weeks of renally adjusted dosing of DS-5565 compared to placebo.
    E.2.2Secondary objectives of the trial
    • To compare change in weekly average pain as assessed by average daily pain score (ADPS) from baseline measured at randomization to Week 13 in subjects receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the subject that best describes the worst pain over the previous 24 hours
    •To assess the effects of DS-5565 on patient global impression of change (PGIC) at Week 13/ET.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Able to give written informed consent
    3. Able to complete patient-reported questionnaires per the Investigator's judgment
    4. Estimated CrCl between 15-59 mL/min from serum creatinine by the central laboratory using the Cockcroft-Gault equation
    5. Fibromyalgia meeting American College of Rheumatology criteria for FM:
    a. Widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5, or WPI 3 to 6 and SS scale score ≥ 9,
    b. Pain in at least 11 of 18 specific tender point sites,
    c. Symptoms have been present at a similar level for at least 3 months, and
    d. The subject does not have a disorder that would otherwise explain the pain
    6. ADPS of ≥ 4 on the 11-point numeric rating scale (NRS) over the 7 days prior to randomization (based on completion of at least 4 daily pain assessments during the 7-day baseline period prior to randomization)
    7. Women of child bearing potential (WOCBP) must be using adequate methods of contraception (as detailed in Section 4.1.3) to avoid pregnancy during the study and for 4 weeks after study completion.
    E.4Principal exclusion criteria
    1. Need for ongoing use of concomitant chronic pain medications or any new non-pharmacological pain management techniques that may confound assessments of efficacy and/or safety, including neurolytic treatments (destruction of nerves by chemicals, heat, cold) or surgery, intrathecal pumps, spinal cord stimulators or psychological support
    within the previous year. Also excluded: topical capsaicin within 6 months; or systemic corticosteroids within 3 months of baseline period.
    2. Unable to undergo pre-study washout of prohibited concomitant medications
    3. Subjects with recent history (i.e., within 1 year prior to screening) of alcohol abuse or illicit drug use (cocaine, heroin, marijuana [including medical, prescribed], etc.)
    4. Use of any selective serotonin reuptake inhibitor (SSRI), unless the subject has been on a stable dose
    for ≥ 90 days prior to screening and is not anticipated to need any dose adjustment during the course of the study
    5. Subjects with severe or uncontrolled depression that, in the judgment of the Investigator, makes the subject inappropriate for entry into the study
    6. Significant neurological or psychiatric disorder unrelated to neuropathic pain
    7. Other severe pain (eg, sciatica, rheumatoid arthritis) that might impair the assessment of neuropathic
    pain
    8. CrCl ≥ 60 mL/min estimated from serum creatinine by the central laboratory using the Cockcroft-Gault
    equation.
    9. Subjects who are on hemodialysis or who require hemodialysis before the follow-up assessment;
    acute renal failure; history of kidney transplant
    10. Any history of a malignancy other than basal cell carcinoma within the past 5 years
    11. Clinically significant unstable neurologic, ophthalmologic, hepatobiliary, respiratory, or hematologic illness or unstable cardiovascular disease (eg, severe hypotension, uncontrolled cardiac arrhythmia, or myocardial infarction) within 12 months prior to screening
    12. Pregnancy or breast feeding or intent to become pregnant during the study period
    13. Known hypersensitivity to α2δ ligands or other components of the study medications. Note: Prior exposure to DS-5565 is allowed, as long as hypersensitivity to DS-5565 was not observed.
    14. Clinically significant ECG abnormalities at the Screening Visit
    15. Subjects who are at risk of suicide, as defined by their responses to
    the C-SSRS or in the opinion of the Investigator. Note: Subjects
    answering "yes" to any of the C-SSRS questions must be excluded. Such
    subjects should be referred immediately to a mental health professional
    for appropriate evaluation.
    16. Subjects with 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,
    or who answer "yes" to the suicidality question (current or past) on the
    Major Depressive Episode Module (Module A) or who answer "yes" to
    any question in the Suicidality Module (Module B) are excluded. Subjects
    with mild to moderate major depression or anxiety disorders are
    permitted to enroll provided that the investigator assesses the subject
    as clinically stable and appropriate for entry into the study.
    17. Subjects who are unlikely to comply with the protocol (eg, uncooperative attitude, inability to return for subsequent visits, and/or otherwise considered by the Investigator to be unlikely to complete the study)
    18. Subject is currently enrolled in, or it has been fewer than 30 days since ending, another investigational device or drug study or is receiving another investigational agent.
    19. Subjects who are employees or immediate family of employees of the study site, Sponsor, or contract research organization (CRO)
    20. Screening laboratory values outside the limits listed in the protocol
    E.5 End points
    E.5.1Primary end point(s)
    The primary safety objective is the safety and tolerability of renally adjusted doses of DS-5565 versus placebo.
    Specific safety endpoints assessed include:
    • All treatment-emergent adverse events (TEAEs)
    • Change in clinical laboratory evaluations from baseline measured at randomization to Week 13/ET for DS-5565 versus placebo
    • Change in neurological examinations from baseline to Week 13/ET for DS-5565 versus placebo
    • Change in electrocardiograms from baseline to Week 13/ET for DS-5565 versus placebo
    • Change in Columbia-Suicide Severity Rating Scale (C-SSRS) from baseline to Week 13/ET for DS-5565 versus placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final evaluation of the primary endpoint will be done at Week 13/ET.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints include:
    • Changes in ADPS from baseline measured at randomization to Week 13/ET for DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the subject that best describes the worst pain over the previous
    24 hours.
    • Proportion of subjects with improvement in overall status at Week 13/ET as assessed by PGIC for DS-5565 versus placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weekly ADPS is based on daily pain scores reported by the subject (from baseline to Week 13) that best describes his or her worst pain over the previous 24 hours.
    The final evaluation of the secondary endpoints will be done at Week 13/ET.
    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 Yes
    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 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 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 EEA47
    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
    Bulgaria
    Czech Republic
    France
    Germany
    Hungary
    Poland
    Romania
    Slovakia
    South Africa
    Spain
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 19
    F.4.2.2In the whole clinical trial 60
    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 Decision2015-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-06
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