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    EudraCT Number:2011-000977-29
    Sponsor's Protocol Code Number:EMA401-003
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-04-27
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedCzech Republic - SUKL
    A.2EudraCT number2011-000977-29
    A.3Full title of the trial
    A double-blind, placebo-controlled, randomised trial to prove the therapeutic concept and to determine the safety, tolerability and pharmacokinetic profile of EMA401 (angiotensin II type 2 receptor antagonist) administered orally in patients with postherpetic neuralgia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of oral EMA401 in the treatment of pain following shingles to see if EMA401 can reduce the level of pain.
    A.4.1Sponsor's protocol code numberEMA401-003
    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.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.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 pointInformation Desk
    B.5.3 Address:
    B.5.3.1Street AddressSouth Yarra Corporate Centre, Suite T18, Level 1, 122 Toorak Road
    B.5.3.2Town/ citySOUTH YARRA
    B.5.3.3Post codeVIC 3141
    B.5.4Telephone number+61 3 9938 1205
    B.5.5Fax number+613 9820 8262
    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 Sodium Salt
    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.3.9.2Current sponsor codeEMA401
    D.3.9.3Other descriptive namesodium salt of the parent carboxylic acid which is an angiotensin II type 2 (AT2) receptor antagonist
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    postherpetic neuralgia
    E.1.1.1Medical condition in easily understood language
    pain following shingles
    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 14.0
    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.1.3Condition 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 when administered orally, twice daily (100 mg b.i.d.), in patients with postherpetic neuralgia, as assessed by difference in mean pain intensity score compared to placebo.
    E.2.2Secondary objectives of the trial
    1. To evaluate the potential efficacy of EMA401 using several alternate endpoints (see efficacy parameters)
    2. To evaluate the safety and tolerability of EMA401 in patients with postherpetic neuralgia
    3. To evaluate the pharmacokinetics of EMA401 in patients with postherpetic neuralgia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Be able to give voluntary written informed consent to participate in the study.
    2.Be over 18 years of age.
    3.Be diagnosed as suffering from PHN defined as pain persisting for more than six months after onset of herpes zoster rash.
    4.Be diagnosed as suffering from moderate to severe pain across the Screening Period. The assessment of moderate and severe pain will be made using an algorithm proprietary to Spinifex Pharmaceuticals. The investigator will be informed immediately as to whether the patient is eligible or ineligible on entering all the relevant pain scores in the electronic data capture portal.
    5.Willing and be able to comply with all study procedures.
    6.For females, have a negative pregnancy test at the Screening visit (Visit 1) and at Visit 2 (Day 1) prior to administration of study medication.
    7.For females, be 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.
    For males: Agrees 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.
    Approved methods of contraception include:
    •Surgical sterilization (vasectomy at least six months prior to dosing)
    •Condom use by male partners of female patients or by male patients.
    •Birth control pills, diaphragm with vaginal spermicide, intra uterine device (IUD), contraceptive hormonal patches, implants or injections by female patients or female partners of male patients
    8.Be fluent in the language of the endpoint scales provided to patients in the study.
    E.4Principal exclusion criteria
    1.Be currently receiving any of the prohibited medications listed below and in Section 7.7.2 or have received within 30 days prior to the Screening visit (Visit 1) or is anticipated to receive after the start of the trial (i.e. on or after Visit 1) any new prescription systemic or topical medication for their PHN. Patients may be enrolled if stable on therapy for their PHN as specified in the permitted medications with restrictions below and in Section 7.7.1
    2.Have received an investigational drug within 30 days or 10 half-lives of the drug, whichever is longer, prior to the Screening visit (Visit 1) or have previously received EMA401.
    3.Known to be allergic to EMA401 or any of the excipients or who have a history of an allergic reaction to previous medication that required management by a health care professional.
    4.Have a clinically significant history of systemic allergic disease (e.g., urticaria, atopic dermatitis).
    5.Have a blood pressure, after resting for at least 5 minutes, outside a systolic blood pressure range of 100-150 mmHg or a diastolic blood pressure outside a range of 50-90 mmHg on two consecutive measurements (at least 10 minutes apart and completed within 20 minutes of the initial measurement).
    6.Have a pulse rate, after sitting for at least 5 minutes, greater than 100 beats per minute (bpm) or lower than 50 bpm, or 45 bpm if on beta blockers, on two consecutive measurements (at least 10 minutes apart and completed within 20 minutes of the initial measurement).
    7.Known to be diabetic.
    8.Consume more than four units of alcohol daily for a man or three units of alcohol for a woman (one unit = 300 mL beer, one glass of wine, one measure of spirits) or has a history of alcohol abuse/dependence.
    9.Have evidence of significant renal insufficiency, indicated by an estimated creatinine clearance using the Cockcroft-Gault formula of less than 50 mL/min at Screening (Visit 1).
    10.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 (Visit 1).
    11.Other than pain as a result of postherpetic neuralgia, have an active, uncontrolled medical condition (e.g., neurological, gastrointestinal, renal, hepatic, cardiovascular, pulmonary, metabolic, endocrine, haematological, genitourinary or other major disorder), or psychiatric illness (e.g., depression, schizophrenia), or any other significant clinical disorder or laboratory finding that in the opinion of the investigator, precludes participation in the study or may interfere with the study objectives.
    12.Other than pain as a result of postherpetic neuralgia, have had a clinically significant illness or operative procedure within 4 weeks of the Screening visit (Visit 1) (e.g. influenza, myocardial infarction).
    13. Have undergone neurolytic or neurosurgical therapy for postherpetic neuralgia.
    14.Have other moderate to severe pain condition that may confound the self-evaluation of pain due to postherpetic neuralgia.
    15.Have skin conditions in the affected area that in the investigator’s opinion could alter sensation.
    16.Have active herpes zoster upon physical examination at Screening (Visit 1) or during the study.
    17.Have hepatitis B (HBV), hepatitis C (HCV) or human immunodeficiency virus (HIV) infection as defined by being seropositive for hepatitis B surface antigen (HBsAg), HCV antibodies or HIV antibodies respectively.
    18.Have a history of at least one genital herpes outbreak.
    19.Are pregnant or lactating.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: Change in mean pain intensity score (using the 11-point numerical rating scale/Likert scale) between baseline and the last week of dosing (Day 22 to 28).
    E.5.1.1Timepoint(s) of evaluation of this end point
    A patient's daily pain intensity score across the preceding 24 hours will be recorded at a single timepoint in the evening prior to sleep. The daily pain intensity score will be used to calculate the mean pain intensity score at both baseline (consists of daily pain scores recorded over 7 consecutive days during the Screening Period) and across the last week (Day 22 to 28) of the Treatment Period.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    1.Onset and maintenance of effect as defined by pattern of change in the mean pain intensity score over the entire Treatment Period.
    2.Proportion of patients achieving a ≥30% reduction in mean pain intensity score compared to baseline (i.e. responder rate).
    Tertiary efficacy endpoints:
    1.Time to 30% decrease from baseline in mean pain intensity score
    2.Quality of Life assessed by the 7-Item Pain Interference aspect of the Brief Pain Inventory (BPI) and the complete Insomnia Severity Index (ISI) [at baseline (Day 1) and Day 28]
    3.Patient ratings assessed by Patient Global Impression of Change Scale (PGIC) [at Day 28]
    4.Description of some of the qualities of patients’ pain (e.g. throbbing, gnawing shooting) assessed by the modified version of the Short-Form McGill Pain Questionnaire (SF-MPQ-2) [at baseline (Day 1) and Day 28]
    5.Emotional and Psychological Functioning assessed by Depression Anxiety Positive Outlook Scale (DAPOS) and Pain Catastrophising Scale (PCS) [at baseline (Day 1) and Day 28]

    E.5.2.1Timepoint(s) of evaluation of this end point
    Over the entire Treatment Period.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    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. 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Czech Republic
    South Africa
    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
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F. of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F. of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F. of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F. of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F. of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F. of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 104
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 68
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 172
    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)
    Normal treatment of this 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 Decision2011-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-07-11
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