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    Summary
    EudraCT Number:2011-004033-13
    Sponsor's Protocol Code Number:EMA401-005
    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:2012-02-14
    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 number2011-004033-13
    A.3Full title of the trial
    A Phase 2 open label biomarker study of angiotensin II type 2 receptor antagonist EMA401 for the treatment of pain in patients with chemotherapy-induced peripheral neuropathy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of EMA401 and biomarkers in the treatment of pain due to nerve damage following chemotherapy.
    A.3.2Name or abbreviated title of the trial where available
    A study of EMA401 and biomarkers in the treatment of pain due to nerve damage following chemotherapy
    A.4.1Sponsor's protocol code numberEMA401-005
    A.5.4Other Identifiers
    Name:Australia New Zealand Clinical Trial RegistryNumber:ACTRN12611001092987
    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 SponsorSpinifex Pharmaceuticals Pty Ltd
    B.1.3.4CountryAustralia
    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 supportSpinifex Pharmaceuticals Pty Ltd
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSpinifex Pharmaceuticals Pty Ltd
    B.5.2Functional name of contact pointCEO & Managing Director
    B.5.3 Address:
    B.5.3.1Street AddressSuite T18, Level 1, 122 Toorak Rd
    B.5.3.2Town/ citySouth Yarra
    B.5.3.3Post code3141
    B.5.3.4CountryAustralia
    B.5.4Telephone number6139938 1205
    B.5.5Fax number6139820 8262
    B.5.6E-mailtom.mccarthy@spinifexpharma.com.au
    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 nameEMA401
    D.3.4Pharmaceutical form Capsule
    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.3.9.2Current sponsor codeEMA401
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chemotherapy induced peripheral neuropathy
    E.1.1.1Medical condition in easily understood language
    Pain and sensory loss due to nerve damage caused by cancer chemotherapy
    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 LLT
    E.1.2Classification code 10040039
    E.1.2Term Sensory peripheral neuropathy
    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 determine the efficacy of EMA401 100 mg orally twice daily for 28 days, in reducing spontaneous neuropathic pain, from baseline to Week 4, in patients with chemotherapy-induced peripheral neuropathy.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of EMA401 100 mg orally twice daily for 28 days in restoring nerve fibre phenotype in skin punch biopsies.

    - To evaluate the efficacy of EMA401 100 mg orally twice daily for 28 days in reducing evoked pain in patients with chemotherapy-induced peripheral neuropathy.

    - To evaluate the safety and tolerability of EMA401 100 mg orally twice daily for 28 days in patients with chemotherapy-induced peripheral neuropathy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Are able to give voluntary written informed consent to participate in the study.

    2. Are 18 to 80 years old inclusive.

    3. Have previously received taxane and/or platinum based chemotherapy for any type of cancer and are not expected to receive further chemotherapy for the study duration.

    4. Show signs and symptoms of sensory peripheral neuropathy of the lower limbs which have been clinically stable for at least 8 weeks prior to Screening.

    5. Have a history of spontaneous pain in the lower limbs for at least 8 weeks prior to Screening.

    6. Have an average evening Numerical Pain Rating Scale (NPRS) score of ≥4 for spontaneous pain in the lower limbs across seven consecutive days during the Screening period.

    7. Are female of non-child-bearing potential (i.e. either surgically sterilised or one year post-menopausal), or if of child-bearing potential, must have used adequate contraceptive precautions for 30 days prior to Screening, and must agree to use two approved methods of contraception for the duration of the study and for one month after administration of the last dose of study medication
    OR
    Are male and agree to use two approved methods of contraception for the duration of the study and until one month after administration of the last dose of the study medication.

    8. Are able to read and understand English.

    9. Have a telephone.
    E.4Principal exclusion criteria
    1. Are pregnant or breast-feeding.

    2. Do not and cannot comply with the protocol concomitant medication restrictions.

    3. Have participated in an investigational medical product study within the 3 months prior to Day 1.

    4. Exposure to more than 3 new chemical entities within the 12 months prior to Day 1.

    5. Have previously received EMA401.

    6. Are known to be allergic to EMA401 or any of the excipients.

    7. Have a history or evidence of any other clinical neuropathy.

    8. Have any other pain condition or injury that may confound the self-evaluation of pain due to peripheral neuropathy.

    9. Have any history of clinically significant cardiac arrhythmias or the presence of clinically significant abnormalities on electrocardiogram (ECG) at screening.

    10. Resting supine blood pressure > 165/95mmHg.

    11. Have a resting pulse rate >100 or <50 beats per minute (bpm) on two consecutive measurements at least 10 minutes apart.

    12. Have a calculated creatinine clearance (using Cockroft and Gault formula) of less than 50 mL/min at Screening.

    13. Have serum aspartate transaminase (AST), gamma glutamyl transaminase (GGT) or alanine transaminase (ALT) levels greater than 3.0 x the upper limit of normal or have total bilirubin concentrations greater than 2.0 x the upper limit of normal at Screening.

    14. History of or current hepatitis B (HBV), hepatitis C (HCV) or human immunodeficiency virus (HIV) infection.

    15. Other than the condition under study, have a history of or current active medical condition including allergic, skin, cardiovascular, psychiatric disease, drug or alcohol abuse, or laboratory finding, that in the opinion of the investigator precludes participation in the study, or may interfere with the study objectives / results.

    16. Patients with pacemaker or implanted brain or cord stimulators.
    E.5 End points
    E.5.1Primary end point(s)
    Change in mean spontaneous pain intensity score using the NRPS score between baseline and the last week of dosing (Days 22 to 28). The mean pain intensity score will be calculated using the daily evening scores for the 7 consecutive days of each period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 29
    E.5.2Secondary end point(s)
    Efficacy
    - Changes in lateral calf skin biopsy nerve and growth factor markers from pre-treatment to Day 29.

    - Change in area of evoked pain from baseline to Day 29, using brush, monofilaments, pin prick, thermal thresholds, and CHEPS.

    - Change in evoked pain intensity NPRS score from baseline to Day 29.

    - Patient ratings assessed by PGIC at Day 29.

    - Description of some of the qualities of patients’ pain (e.g. throbbing, gnawing shooting) assessed by the modified version of the SF-MPQ-2 at baseline and Day 29.

    Safety
    - Incidence and severity of AEs, and changes and findings in laboratory parameters, physical and neurological examinations, vital signs, and ECG.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 29
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.3 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    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 months9
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days14
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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.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)
    EMA401 will not be made available to patients after the end of the study as the efficacy and safety of EMA401 has not been established in this patient population.
    Patients will return to their usual care after their trial participation ends.
    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 Decision2012-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-21
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