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    Summary
    EudraCT Number:2013-002521-27
    Sponsor's Protocol Code Number:8477-CL-0020
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-11-15
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-002521-27
    A.3Full title of the trial
    A Phase 2a Enriched Enrollment Randomized Withdrawal Study to Assess Analgesic Efficacy and Safety of ASP8477 in Subjects with Peripheral Neuropathic Pain
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effect on pain relief and safety of a new treatment (ASP8477) with a mock treatment (placebo) in subjects with Peripheral Neuropathic Pain
    A.3.2Name or abbreviated title of the trial where available
    MOBILE
    A.4.1Sponsor's protocol code number8477-CL-0020
    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 SponsorAstellas Pharma Europe B.V. (APEB)
    B.1.3.4CountryNetherlands
    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 supportAstellas Pharma Europe B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V.
    B.5.2Functional name of contact pointService Desk
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+3171545 50 50
    B.5.5Fax number+3171545 55 01
    B.5.6E-mailcontact@nl.astellas.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 ASP8477
    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 INNNot available
    D.3.9.2Current sponsor codeASP8477
    D.3.9.4EV Substance CodeSUB32086
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Peripheral Neuropathic Pain
    E.1.1.1Medical condition in easily understood language
    Pain in the skin caused by a disorder of the nerves
    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 16.1
    E.1.2Level PT
    E.1.2Classification code 10036376
    E.1.2Term Post herpetic neuralgia
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10012683
    E.1.2Term Diabetic peripheral neuropathy
    E.1.2System Organ Class 10029205 - Nervous system 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 analgesic efficacy of ASP8477 relative to placebo in subjects with peripheral neuropathic pain as determined by the change in the average daily pain intensity in responders.
    E.2.2Secondary objectives of the trial
    Key Secondary Objective
    - To assess analgesic efficacy of ASP8477 relative to placebo in subjects with peripheral neuropathic pain, as determined by the time to efficacy failure in responders.
    Other Secondary Objectives
    - To assess additional measures of efficacy of ASP8477.
    - To assess safety and tolerability of ASP8477 in responders and non-responders during the Single-Blind Period, and relative to placebo during the Double-Blind Randomized Withdrawal Period.
    - To assess pharmacokinetics of ASP8477 in responders and non-responders.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally
    authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
    2. Subject is a male or female subject, ≥ 18 years of age, at Screening.
    3. Subject has neuropathic pain resulting from PDPN or PHN per the investigator judgment.
    4. Subject taking chronic pain medications (with the exception of opioids and cannabinoids, which are not allowed) must be on a stable regimen for ≥ 1 month before Screening. This stable regimen cannot include PRN (occasional or as-needed) analgesia or PRN non-medication therapy.
    E.4Principal exclusion criteria
    1. Subject has significant pain (moderate or above) of an etiology other than PDPN or PHN (e.g., compression-related neuropathies [e.g., spinal stenosis, fibromyalgia or arthritis]), that may interfere with assessment of PDPN-, or PHN-related pain.
    2. Subject has a documented history of an adverse reaction (hives, rash, etc.) or a clinically significant intolerance to non-steroidal anti-inflammatory drugs (NSAIDs) or excipients of NSAIDs or ASP8477 medication.
    3. Subject has a history of drug or alcohol abuse within 2 years prior to Screening., and/or will not agree to limit alcohol consumption to socially acceptable levels during the study
    4. Subject is currently using protocol specified prohibited medications or non-medication therapies; including Over The Counter (OTC) products (refer to Concomitant Medication Restrictions or Requirements Section IV or Section 5.1.3 for details). A list of prohibited medications is provided in Appendix 12.1.
    E.5 End points
    E.5.1Primary end point(s)
    Change in mean of 24-hour average pain intensity, NPRS, from baseline of the Double-Blind Randomized Withdrawal Period to the last 3 days of the Double-Blind Randomized Withdrawal period in the responder population (≥ 30% decrease in mean average daily pain intensity at baseline of the Double-Blind Randomized Withdrawal Period versus baseline of the Single-Blind Period).
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline of the Double-Blind Randomized Withdrawal Period to the last 3 days of the Double-Blind Randomized Withdrawal Period.
    E.5.2Secondary end point(s)
    Key secondary efficacy endpoint:
    - Time to treatment failure, defined as time from randomization to the first of 3 consecutive days in which mean 24-hour pain intensity was ≥ 4, with at least a 30% increase in pain intensity relative to baseline of the Double-Blind Randomized Withdrawal Period in the responder population.
    Other secondary efficacy endpoints:
    - Responder rate to ASP8477 in the Single-Blind Period, defined as ≥ 30% reduction in pain intensity from average of last three days NPRS score in placebo run-in to the average of the NPRS score of the final three days in the Single-Blind Period
    - Patient Global Impression of Change (PGIC) for overall patient status at the EOT/ED Visit for all subjects.
    Pharmacokinetic endpoints:
    - Individual pre- and post-dose plasma concentrations of ASP8477
    E.5.2.1Timepoint(s) of evaluation of this end point
    -From randomization to the first of 3 consecutive days in which mean 24-hour pain intensity was ≥ 4
    -From baseline of the Single-Blind Period to the baseline of the Double-Blind Period
    -At EOT/ED 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 No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    EERW design with a single blind period followed by double-blind randomized withdrawal period
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 months3
    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 months3
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 Information not present in EudraCT
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    .
    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 Decision2014-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-02-13
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