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    Summary
    EudraCT Number:2013-004876-37
    Sponsor's Protocol Code Number:PL37-C03-2013
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-03-31
    Trial 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 ConcernedUK - MHRA
    A.2EudraCT number2013-004876-37
    A.3Full title of the trial
    A 4 week phase 2a, multicentre, randomised, double-blind, placebo-controlled add-on study into safety, tolerability and efficacy of 200 mg t.i.d. of PL37 in patients with peripheral neuropathic pain of diabetic origin treated with pregabalin or gabapentin.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the effectiveness and safety of PL37 in reducing pain intensity when given in addition to gabapentin or pregabalin in patients suffering from neuropathic pain of diabetic origin, for whom ongoing treatment with gabapentin or pregabalin does not provide complete or sufficient relief of their neuropathic pain.
    A.4.1Sponsor's protocol code numberPL37-C03-2013
    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 SponsorPharmaleads SA
    B.1.3.4CountryFrance
    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 supportPharmaleads SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmaleads SA
    B.5.2Functional name of contact pointMichel Wurm
    B.5.3 Address:
    B.5.3.1Street Address11 Rue Watt
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75013
    B.5.3.4CountryFrance
    B.5.4Telephone number00 331 44 06 70 04
    B.5.5Fax number00 331 44 06 60 99
    B.5.6E-mailmichel.wurm@pharmaleads.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 namePL37
    D.3.2Product code PL37
    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 INNN/A
    D.3.9.2Current sponsor codePL37
    D.3.9.3Other descriptive namePL37
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Neuropathic pain develops as a result of damage to, or dysfunction of, the system that normally signals pain. It may arise from a heterogeneous group of disorders that affect the peripheral and central nervous systems. People with neuropathic pain may experience altered pain sensation, areas of numbness or burning, and continuous or intermittent evoked or spontaneous pain. In this study, neuropathic pain of diabetic origin is being investigated.
    E.1.1.1Medical condition in easily understood language
    Neuropathic pain is pain that comes from problems with signals from the nerves. There are various causes. It is different to the common type of pain that is due to an injury, burn, pressure, etc.
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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 assess the efficacy of 200mg t.i.d. of PL37 + pregabalin or gabapentin compared to pregabalin or gabapentin plus placebo in the reduction of pain intensity in patients suffering from neuropathic pain of diabetic origin.
    E.2.2Secondary objectives of the trial
    To assess the safety/tolerability and efficacy of 200mg t.i.d. of PL37 + pregabalin or gabapentin compared to pregabalin or gabapentin plus placebo on:
    1. Clinical and biological safety profile including occurrence of Adverse Events, the potential changes in vital signs, ECG and biological parameters.
    2. Patient and clinician ratings of improvement and treatment satisfaction (Patient Global Impression of Change [PGIC] scale and the Clinical Global Impression of Change [CGIC, respectively])
    3. Changes in the nature of the patient’s subjective assessment of neuropathic pain (DN4 Questionnaire)
    4. Changes in the patient’s subjective assessment of diabetic neuropathic pain (Michigan Neuropathy Screening Instrument [MNSI]
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Willing and able to provide written informed consent prior to any study related procedures
    • Male or female, aged ≥18 years and ≤75 years
    • Willing to comply with all study procedures and be available for the duration of the study
    • Diagnosed (confirmed by pain specialist or endocrinologist) with peripheral neuropathic pain of diabetic origin
    • Neuropathic pain lasting for at least 3 months
    • Mean 24-hour average pain intensity score of 4 or higher, as calculated from a minimum of 5 NRS ratings recorded by the patient over the 7 days period after the screening and prior to the randomisation visit and also between the randomisation and the dispensing visit (this eligibility criterion will be provided by IVR system/ePRO diary)
    • Stable treatment with pregabalin or gabapentin for at least one month prior to screening visit
    • Adequately controlled diabetes (HbA1c ≤ 10% or 86 mmol/ml)
    • Women of reproductive potential must use highly effective contraception from screening to 1 week after end of study treatment. (A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1 percent per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomised partner
    • Men of reproductive potential must use condoms from screening to 1 week after end of study treatment
    • HADS Depression score ≤ 11
    • Stable dose of any allowed central nervous system (CNS) - acting medications for at least one month prior to screening visit
    E.4Principal exclusion criteria
    • Unstable angina, heart failure and significant pulmonary disease requiring home oxygen
    • Severe renal disease defined as eGFR < 30 mL/min/1,73m2 calculated by using either the CKD-EPI or MDRD equation
    • Liver disease or any liver function test > 2.5 x ULN
    • Other painful medical conditions that could interfere with study outcomes (rheumatoid arthritis, inflammatory bowel disease, mechanical lower back disorders)
    • Use of disallowed concomitant medications (systemic analgesic, opioids or anti-inflammatory medications [other than paracetamol] or capsaicin cream during two weeks prior to screening visit)
    • Recent (last 2 weeks) febrile illness that precludes or delays participation
    • Inability to swallow study medication
    • Pregnant females as determined by positive urine pregnancy at randomisation visit
    • Breastfeeding females
    • Known hypersensitivity or intolerance to components of the study product(s)
    • Treatment with another investigational drug or other intervention during the last 4 weeks prior to screening visit
    • History of drug/alcohol abuse
    • History of severe psychiatric disorder
    • Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject’s full compliance with or completion of the study
    E.5 End points
    E.5.1Primary end point(s)
    Change in weekly mean of the 24-hour average pain intensity, self-assessed using the NRS for pain, and reported daily in the ePRO diary from baseline to end of treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to end of treatment.
    E.5.2Secondary end point(s)
    Safety Endpoints:
    - Percentage of patients with treatment-emergent AEs
    - Change in ECG parameters from baseline
    - Change in Vital Sign parameters from baseline
    - Change in laboratory parameters from baseline

    Efficacy endpoints:
    - Proportion of patients who have "improved", "much improved" or "very much improved" relative to baseline on the Patient Global Impression of Change (PGIC) at end of treatment.
    - Proportion of patients who have "improved", "much improved" or "very much improved" relative to baseline on the Clinical Global Impression of Change (CGIC) at end of treatment.
    - Change in score of the patient’s subjective assessment of neuropathic pain from baseline to end of treatment, assessed by physician administered DN4 questionnaire,
    - Change in score of the patient’s subjective assessment of diabetic neuropathic pain from baseline to end of treatment, assessed by MNSI questionnaire.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to end 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 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 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    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 months4
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Cheshire and Merseyside Comprehensive Local Research Network
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-31
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-03-09
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