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    Summary
    EudraCT Number:2018-004534-15
    Sponsor's Protocol Code Number:LAT-NP-001
    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:2019-07-25
    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 number2018-004534-15
    A.3Full title of the trial
    A Phase IIa study of the efficacy and safety of oral LAT8881 in neuropathic pain
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    LAT881 in Neuropathic Pain
    A.3.2Name or abbreviated title of the trial where available
    LAT8881 in Neuropathic Pain
    A.4.1Sponsor's protocol code numberLAT-NP-001
    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 SponsorLateral Pharma 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 supportLateral Pharma Pty Ltd
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLateral Pharma Pty Ltd
    B.5.2Functional name of contact point
    B.5.3 Address:
    B.5.3.1Street Address14/114 William Street
    B.5.3.2Town/ cityMelbourne
    B.5.3.3Post code3000
    B.5.3.4CountryAustralia
    B.5.4Telephone number+61 438 020 177
    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 LAT8881 (previously known as AOD9604)
    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 codeLAT8881
    D.3.9.3Other descriptive nameTyr-hGH177-191
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    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 (NP), associated with either postherpetic neuralgia (PHN) or diabetic peripheral neuropathy (DPN)
    E.1.1.1Medical condition in easily understood language
    Nerve pain
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term 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 evaluate the efficacy (whether the drug works) of oral LAT8881 in neuropathic pain compared with placebo, when assessed by change in mean pain intensity scores from baseline to the end of four weeks treatment, based on an 11 point numeric pain rating scale (NPRS).
    E.2.2Secondary objectives of the trial
    • To investigate the effect of LAT8881 in NP compared with placebo at different timepoints (up to 6 hours) following a single dose and after 4 weeks treatment measured by the NPRS (PK subjects only)
    • To investigate the effect of LAT8881 on mean pain scores after 1, 2, 3 wks
    • To determine the proportion of responders to LAT8881
    • To investigate the maximum effect of LAT8881
    • To evaluate the effect of LAT8881 on functioning in subjects with NP
    • To evaluate the effect of LAT8881 on pain symptoms measured by SF-MPQ-2
    • To evaluate the effect of LAT8881 on symptoms measured by the NPSI
    • To evaluate the effect of LAT8881 on emotional functioning measured by the BDI-II
    • To evaluate the effect of LAT8881 on overall health and quality of life QoL measured by the PGIC scale
    • To determine the change from baseline in paracetamol rescue medication use during LAT8881 administration
    • To evaluate the safety and tolerability of LAT8881
    • To investigate the PK of LAT8881

    Exploratory obje
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Clinical diagnosis of post herpetic neuralgia, with pain persisting for at least 3 months after the onset of herpes zoster rash
    OR
    2. Clinical diagnosis of distal painful polyneuropathy due to Type I or Type II diabetes mellitus with:
    a) symmetrical, bilateral pain in the lower extremities for at least 3 months and
    b) diabetes under control for at least 3 months prior to randomisation, as indicated by a glycated haemoglobin level (HbA1c) of ≤ 11% (97 mmol/mol) and on a stable dose of insulin or oral diabetic medication for 3 months prior to screening, and
    c) no change in diabetic medication planned for the duration of the study
    3. Positive sensory symptoms (mechanical or thermal) associated with neuropathic pain, confirmed by:
    a) painDETECT questionnaire (PD-Q) and
    b) Clinical assessment, showing signs of neuropathic pain in either a dermatomal (PHN) or distal symmetrical distribution (DPN)
    4. Aged 18 to 75 years
    5. Subjects must be sufficiently competent in English to understand the purposes and risks of the study and able to give voluntary written informed consent to participate in the study
    6. Willing and able to comply with all study procedures
    7. Completion of at least five NPRS scores during the week preceding randomisation
    8. An average daily pain score on the NPRS of at least 4 and no more than 8 in the last five diary entries before randomisation
    9. No more than one score on the NPRS of 9 or more, and no more than one score of 2 or less, in the last five diary entries before randomisation
    10. Females of child bearing potential must have a negative pregnancy test at Visit 1 (Screening) and at Visit 2 (Day 1) prior to administration of IMP
    11. Female subjects must be:
    a) of non child-bearing potential [surgically sterilised or post–menopausal (12 months with no menses without alternative medical cause)] OR
    b) not pregnant, breast feeding or planning to become pregnant AND willing to comply with the medically acceptable contraceptive requirements of the study from Screening to at least 28 days after the last IMP administration
    E.4Principal exclusion criteria
    1. Presence of moderate to severe pain from other causes that may confound assessment or self-evaluation of NP.
    2. Subjects with both DPN and PHN
    3. Skin conditions in the affected area that could alter sensation or assessments
    4. History of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunological, neurological, ophthalmological, haematological or psychiatric disorder or any other condition, which in the opinion of the investigator or sponsor would jeopardise the safety of the subject or the validity of the study results
    5. Medical history of, or currently active, human immunodeficiency virus, hepatitis B or hepatitis C virus
    6. Clinically significant abnormal 12-lead electrocardiogram (ECG) at screening
    7. Immunocompromised state, or conditions known to be associated with an immunocompromised state
    8. Clinically significant or unstable medical or psychological condition that would compromise participation in the study
    9. Recent history of malignancy within 5 years preceding screening (except resected cervical or skin cancer [except melanoma]). Subjects who have had no evidence of disease in the last 5 years are eligible
    10. Active herpes zoster infection on screening
    11. Current alcohol abuse, illicit or illegal drug use
    12. Use of prohibited medication (see study medications)
    13. Previous treatment with LAT8881 (formerly identified as AOD9604) within the last 5 years
    14. Participation in an investigational trial within 60 days or 5 half-lives (whichever is longer) prior to screening
    15. History of significant hypersensitivity to LAT8881 or drugs of a similar pharmacological class (e.g. somatropin)
    16. Surgical or medical conditions which could significantly alter drug absorption, distribution, metabolism or excretion
    17. An employee of the sponsor or research site personnel directly affiliated with this study, whether biological or legally adopted, or their immediate family members, defined as a spouse, parent, sibling, or child
    18. Previous neurolytic or neurosurgical therapy for PHN or DPN
    19. PK subjects:
    a) Blood or plasma donation of more than 500 mL during the 3 months prior to randomisation
    b) History of fainting during phlebotomy
    E.5 End points
    E.5.1Primary end point(s)
    •Absolute change in mean pain score, using an 11 point NPRS, from baseline to the last week of each treatment period. Pain is recorded once daily in a subject diary, in the evening, and should reflect the subject’s average pain over the last 24 hours
    Baseline mean pain for each subject is defined as the mean of the last five available ratings of daily pain, recorded in each baseline period.
    End of treatment mean pain for each subject is defined as the mean of the last five available ratings of daily pain, recorded in the last 7 days of each 4 week treatment period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Last week of each treatment period
    E.5.2Secondary end point(s)
    • Change in NPRS score at 0.5, 1, 2, 4 and 6 hours after the first dose of IMP in each treatment period, compared with the score recorded no more than 60 minutes before the first dose of IMP in that treatment period (PK subjects only)
    • Change in NPRS score at 0.5, 1, 2, 4 and 6 hours after a single dose of IMP, following four weeks treatment with IMP in each treatment period, compared with the score recorded no more than 60 minutes before this dose (PK subjects only)
    • Change in mean pain scores from baseline after 1, 2 and 3 weeks of dosing with IMP in each treatment period, using an 11 point NPRS. Mean pain scores at weeks 1, 2 and 3 are defined as the mean of the last five available ratings of daily pain in the subject diary, recorded in the previous 7 days of treatment
    • 30% responder rate, based on the proportion of subjects achieving ≥ 30% reduction in mean NPRS from baseline to the end of 4 weeks treatment in each treatment period
    • 50% responder rate, based on the proportion of subjects achieving ≥ 50% reduction in mean NPRS from baseline to the end of 4 weeks treatment in each treatment period
    • Maximum change in mean NPRS from baseline after 1, 2, 3 or 4 weeks treatment in each treatment period
    • Change in functioning from baseline to the end of 4 weeks treatment in each treatment period, as assessed by the BPI interference scale
    • Change in pain characteristics and intensity from baseline to the end of 4 weeks treatment in each treatment period, as assessed by the SF-MPQ-2
    • Change in neuropathic pain symptoms from baseline to the end of 4 weeks treatment in each treatment period, as assessed by NPSI
    • Change in emotional functioning from baseline to the end of 4 weeks treatment in each treatment period, as assessed by the BDI-II
    • PGIC at the end of each four week treatment period
    • Paracetamol (rescue medication) use per week over each treatment period compared with the preceding baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Change in NPRS score:After first dose and following 4 wks treatment with IMP in each treatment period
    -Change in mean pain scores:After 1,2 and 3 wks of dosing with IMP in each treatment period
    -30% responder rate:end of 4 weeks treatment in each treatment period
    -50% responder rate:end of 4 weeks treatment in each treatment period
    -Maximum change in mean NPRS from baseline:end of 4 wks treatment in each treatment period
    -Change in functioning from baseline:end of 4 wks treatment in each treatment period
    -Change in pain characteristics and intensity from baseline:end of 4 wks treatment in each treatment period
    -Change in neuropathic pain symptoms from baseline:end of 4 wks treatment in each treatment period
    -PGIC:end of each four wk treatment period
    -Paracetamol use:use per wk
    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 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 Yes
    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 concerned2
    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 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
    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
    The end of the study is defined as the date of the data base lock for the final analysis.
    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 days1
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    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: 25
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 55
    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. After withdrawal patients will receive standard medical care according to individual needs.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-05-04
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