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    Summary
    EudraCT Number:2016-000281-39
    Sponsor's Protocol Code Number:CEMA401A2202
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-09
    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 ConcernedNorway - NOMA
    A.2EudraCT number2016-000281-39
    A.3Full title of the trial
    A double-blind, placebo-controlled, randomized trial to determine the safety and efficacy of EMA401 in reducing 24-hour average pain intensity score in patients with painful diabetic neuropathy (EMPADINE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy of EMA401 in patients with painful diabetic neuropathy (PDN)
    A.3.2Name or abbreviated title of the trial where available
    EMPADINE
    A.4.1Sponsor's protocol code numberCEMA401A2202
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Norge AS
    B.5.2Functional name of contact pointMedisinsk informasjon
    B.5.3 Address:
    B.5.3.1Street AddressPostboks 4284 Nydalen
    B.5.3.2Town/ cityOslo
    B.5.3.3Post codeN-0401
    B.5.3.4CountryNorway
    B.5.4Telephone number+47 23 05 20 00
    B.5.5Fax number+47 23 05 20 01
    B.5.6E-mailmedisinsk.informasjon@novartis.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.3.2Product code EMA401
    D.3.4Pharmaceutical form Capsule, hard
    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 INNOlodanrigan
    D.3.9.1CAS number 1316755-17-5
    D.3.9.2Current sponsor codeEMA401
    D.3.9.3Other descriptive nameEMA401
    D.3.9.4EV Substance CodeSUB185865
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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
    Painful Diabetic Neuropathy
    E.1.1.1Medical condition in easily understood language
    Painful Diabetic Neuropathy (complication of diabetes)
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10067547
    E.1.2Term Diabetic peripheral neuropathic pain
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of EMA401 vs. placebo in 24-hour average pain intensity score at Week 12, using an 11 point Numeric Rating Scale (NRS) by testing the superiority of EMA401 vs. placebo
    E.2.2Secondary objectives of the trial
    •Compare the efficacy of EMA401 vs placebo in NPSI total score by testing the superiority of EMA401 vs placebo
    •Evaluate the efficacy of EMA401 compared to placebo, as measured by the BPI-SF total score at Wk 12; as measured by the weekly mean of the 24-hour worst pain intensity score, using the NRS at Wk 12; on the PGIC at Wk 12
    •Evaluate the proportion of EMA401 patients achieving a ≥ 30% and a ≥ 50% reduction in weekly mean 24-hr average pain intensity score using the NRS vs placebo at Wk 12
    •Evaluate the effect of EMA401 vs placebo on the ISI at Wk 12
    •Evaluate the safety and tolerability of EMA401 vs placebo, as measured by treatment-emergent AEs, AEs leading to study drug discontinuation and SAEs
    •Evaluate the PK of EMA401 and exposure-response relationship for EMA401
    •Evaluate the proportion of patients who need rescue medication separately for the treatment epoch and treatment withdrawal epoch and the time to first intake of rescue medication during the treatment epoch
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • At the time of Screening, have documented diagnosis of Type I OR Type II diabetes mellitus (DM) with painful distal symmetrical sensorimotor neuropathy (for example ICD-10 code G63.2) of more than 6 months duration with any one or more of the following:
    - Neuropathic symptoms (e.g. numbness, non-painful paresthesias or tingling, non-painful sensory distortions or misinterpretations, etc.)
    - Decreased distal sensation (e.g. decreased vibration, pinprick sensation, light touch, etc.)
    • Be assessed as suffering from moderate to severe neuropathic pain across the Screening epoch.
    • A score of ≥ 4 on the Douleur Neuropathique en 4 Questions (DN4) questionnaire at Screening.

    Other protocol-defined inclusion criteria may apply.
    E.4Principal exclusion criteria
    • History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for patients participating in the study.
    • Major depressive episode within 6 months prior to Screening and/or a history of diagnosed recurrent major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) diagnostic criteria.
    • Have evidence of significant renal insufficiency or pre-existing liver condition.
    • Have platelets ≤ 100 x 109/L, or neutrophil count < 1.2 x 109/L (or equivalent), hemoglobin ≤ 100 g/L for women or hemoglobin ≤ 110 g/L for men.
    • Participants whose glycemic control has been unstable within 3 months immediately prior to screening (e.g., ketoacidosis requiring hospitalization, any recent episode of hypoglycemia requiring assistance through medical intervention, uncontrolled hyperglycemia).
    • Patients with any differential diagnosis of PDN including but not limited to other neuropathies (e.g. Vitamin B12 deficiency, Chronic Inflammatory Demyelinating Polyneuropathy), polyradiculopathies, central disorders (e.g. demyelinating disease), or rheumatological disease (e.g., foot arthritis, plantar fasciitis).
    • Patient is unwilling or unable to complete daily eDiary.

    Other protocol-defined exclusion criteria may apply.
    E.5 End points
    E.5.1Primary end point(s)
    Change in weekly mean 24-hour average pain score (using the 11 point NRS) from Baseline to Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Week 12
    E.5.2Secondary end point(s)
    • Change in Neuropathic Pain Symptom Inventory (NPSI) total score from Baseline to Week 12
    • Change in Brief Pain Inventory-Short Form (BPI-SF) interference total score from Baseline to Week 12
    • Change in weekly mean of the 24-hour worst pain score, using an 11-point Numeric Rating Scale (NRS), from Baseline to Week 12
    • Patient Global Impression of Change (PGIC) at Week 12
    • Proportion of patients meeting responder criteria from Baseline to Week 12
    • Change in Insomnia Severity Index (ISI) from Baseline to Week 12
    • Number and severity of treatment- emergent adverse events and the frequency of adverse events leading to discontinuation. Number of serious adverse events.
    • Plasma pharmacokinetics of EMA401 will be characterized by population non-linear mixed effects modeling techniques
    • Proportion of patients who need rescue medication separately for the double blind treatment epoch and treatment withdrawal epoch, the time to first intake of rescue medication during the double blind treatment epoch
    E.5.2.1Timepoint(s) of evaluation of this end point
    For full details, please refer to the schedule of assessments table in the protocol.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA74
    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
    Australia
    Austria
    Belgium
    Bulgaria
    Canada
    Denmark
    Finland
    France
    Germany
    Hungary
    Norway
    Poland
    Portugal
    Slovakia
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 325
    F.4.2.2In the whole clinical trial 400
    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)
    Not planned
    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 Decision2018-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-25
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