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    Clinical Trial Results:
    A Phase IIa study of the efficacy and safety of oral LAT8881 in neuropathic pain

    Summary
    EudraCT number
    2018-004534-15
    Trial protocol
    GB  
    Global end of trial date
    04 May 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Jun 2021
    First version publication date
    20 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LAT-NP-001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03865953
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Lateral Pharma Pty Ltd
    Sponsor organisation address
    Level 14, 114 William Street, MELBOURNE, Australia, 3000
    Public contact
    Research & Clinical Trials, Lateral Pharma Pty Ltd, info@lateral-pharma.com
    Scientific contact
    Research & Clinical Trials, Lateral Pharma Pty Ltd, info@lateral-pharma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 May 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    04 May 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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).
    Protection of trial subjects
    This study was conducted in compliance with the study protocol, the requirements and obligations of the International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), the World Medical Association Declaration of Helsinki and its amendments and all applicable local guidelines, laws and regulations.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    20 Mar 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 12
    Country: Number of subjects enrolled
    Australia: 41
    Worldwide total number of subjects
    53
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    31
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 8 sites in total, including Australia (6 sites) and the United Kingdom (2 sites). Enrolment commenced in March 2019 and concluded in February 2020.

    Pre-assignment
    Screening details
    One hundred and eight (108) subjects signed consent and underwent screening procedures, Fifty-three (53) subjects were eligible and randomized, 25 to LAT8881 then placebo (Group 1) and 28 to placebo then LAT8881 (Group 2) treatment groups.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    Only the staff involved in the generation of the randomisation schedule and labelling of clinical trial supplies had access to the randomisation code during study conduct

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    LAT8881 then Placebo
    Arm description
    Following a first baseline assessment of 7 days, 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period. After washout of 14 days, followed by a second baseline of 7 days, matching placebo 1 x 30 mg capsule taken by mouth, twice daily (morning and evening) during the second four-week treatment period.
    Arm type
    Experimental

    Investigational medicinal product name
    LAT8881
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    one LAT8881 capsule taken in the morning and one LAT8881 capsule taken in the evening

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    one placebo capsule taken in the morning and one placebo capsule taken in the evening

    Arm title
    Placebo then LAT8881
    Arm description
    Following a seven day initial baseline, matching placebo (containing excipients only) 1 x 30 mg capsule, taken by mouth, twice daily (morning and evening) during the four-week treatment period. After washout of 14 days, followed by a second baseline of seven days, 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the second four-week treatment period.
    Arm type
    Experimental

    Investigational medicinal product name
    LAT8881
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    one LAT8881 capsule taken in the morning and one LAT8881 capsule taken in the evening

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    one placebo capsule taken in the morning and one placebo capsule taken in the evening

    Number of subjects in period 1
    LAT8881 then Placebo Placebo then LAT8881
    Started
    25
    28
    Treatment Period 1
    25
    28
    Treatment Period 2
    23
    27
    Completed
    23
    25
    Not completed
    2
    3
         Protocol deviation
    -
    1
         Lost to follow-up
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    -

    Reporting group values
    Overall trial Total
    Number of subjects
    53 53
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    59.8 ± 10.13 -
    Gender categorical
    Units: Subjects
        Female
    22 22
        Male
    31 31
    Neuropathic Pain History
    Units: Subjects
        Postherpetic Neuralgia
    10 10
        Diabetic Peripheral Neuropathy
    43 43

    End points

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    End points reporting groups
    Reporting group title
    LAT8881 then Placebo
    Reporting group description
    Following a first baseline assessment of 7 days, 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period. After washout of 14 days, followed by a second baseline of 7 days, matching placebo 1 x 30 mg capsule taken by mouth, twice daily (morning and evening) during the second four-week treatment period.

    Reporting group title
    Placebo then LAT8881
    Reporting group description
    Following a seven day initial baseline, matching placebo (containing excipients only) 1 x 30 mg capsule, taken by mouth, twice daily (morning and evening) during the four-week treatment period. After washout of 14 days, followed by a second baseline of seven days, 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the second four-week treatment period.

    Subject analysis set title
    LAT8881
    Subject analysis set type
    Per protocol
    Subject analysis set description
    A per-protocol (PP) population was based on duration of investigational medical product (IMP) treatment and protocol deviations. This population excluded subjects with inadequate exposure to IMP or who had other major protocol deviations. Rules for this population were included in the SAP. The PP population was the primary population to analyse efficacy endpoints. Demographic and baseline characteristics of the PP population were also be presented.

    Subject analysis set title
    Placebo
    Subject analysis set type
    Per protocol
    Subject analysis set description
    A per-protocol (PP) population was based on duration of investigational medical product (IMP) treatment and protocol deviations. This population excluded subjects with inadequate exposure to IMP or who had other major protocol deviations. Rules for this population were included in the SAP. The PP population was the primary population to analyse efficacy endpoints. Demographic and baseline characteristics of the PP population were also be presented.

    Primary: Absolute change in mean pain score

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    End point title
    Absolute change in mean pain score
    End point description
    The 11-point numeric pain rating scale (NPRS) ranges from 0 (“no pain”) to 10 (“worst pain imaginable”). A larger negative number represents a greater reduction in pain. The efficacy of oral LAT8881 in neuropathic pain was compared with placebo, when assessed by change in mean pain intensity scores, using this 11 point numeric pain rating scale.
    End point type
    Primary
    End point timeframe
    from baseline to the last week of each treatment period (Week 4)
    End point values
    LAT8881 Placebo
    Number of subjects analysed
    23 [1]
    25 [2]
    Units: 0-11
        arithmetic mean (standard deviation)
    -0.87 ± 1.533
    -0.74 ± 2.090
    Notes
    [1] - 23 subjects completed the LAT-8881 to Placebo arm of the study.
    [2] - 25 subjects completed the Placebo-LAT8881 arm of the study
    Statistical analysis title
    Absolute Change in Mean Pain Score
    Statistical analysis description
    Subject numbers gave a 90% power to demonstrate a statistically significant difference in the mean change from baseline NPRS for the active treatment compared with placebo of at least 1 unit, with a two sided test at a 5% level of significance
    Comparison groups
    LAT8881 v Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    = 0.67
    Method
    Mixed models analysis
    Parameter type
    Mean difference (net)
    Point estimate
    -0.14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.76
         upper limit
    0.49
    Notes
    [3] - Analysis used a two-period two-treatment crossover design, with 23 subjects completing the LAT8881-Placebo arm and 25 subjects the Placebo-LAT8881 arm, therefore 48 subjects in total were analysed.

    Secondary: Change in NPRS Score After the First and Last Dose of LAT8881 and Placebo

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    End point title
    Change in NPRS Score After the First and Last Dose of LAT8881 and Placebo
    End point description
    To investigate the effect of oral LAT8881 in neuropathic pain compared with placebo, as measured by the numeric pain rating score (NPRS). The 11-point numeric pain rating scale ranges from 0 (“no pain”) to 10 (“worst pain imaginable”). A larger negative number represents a greater reduction in pain.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.5,1,2,4 and 6 hours after the first and last dose of LAT8881 and placebo
    End point values
    LAT8881 Placebo
    Number of subjects analysed
    14
    14
    Units: 0-11
    arithmetic mean (standard deviation)
        0.5 hours after first dose
    -0.1 ± 0.77
    -0.2 ± 1.53
        1 hour after first dose
    -0.4 ± 0.63
    -0.6 ± 1.95
        2 hours after first dose
    -0.1 ± 0.95
    -0.8 ± 2.26
        4 hours after first dose
    0.1 ± 1.07
    -0.6 ± 2.17
        6 hours after first dose
    0.0 ± 0.68
    -0.7 ± 1.77
        0.5 hours after last dose
    -0.6 ± 2.43
    -0.4 ± 0.84
        1 hour after last dose
    -0.5 ± 2.58
    -0.4 ± 1.02
        2 hours after last dose
    -0.8 ± 2.19
    -0.1 ± 0.77
        4 hours after last dose
    -0.5 ± 2.26
    -0.4 ± 0.93
        6 hours after last dose
    -0.7 ± 1.93
    -0.4 ± 0.84
    No statistical analyses for this end point

    Secondary: Change in Mean Pain Scores After 1, 2 and 3 Weeks of Treatment, Using NPRS

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    End point title
    Change in Mean Pain Scores After 1, 2 and 3 Weeks of Treatment, Using NPRS
    End point description
    To investigate the effect of oral LAT8881 on mean pain scores in neuropathic pain compared with placebo, as measured by the numeric pain rating scale (NPRS). The 11-point numeric pain rating scale ranges from 0 (“no pain”) to 10 (“worst pain imaginable”). A larger negative number represents a greater reduction in pain.
    End point type
    Secondary
    End point timeframe
    1,2 and 3 weeks
    End point values
    LAT8881 Placebo
    Number of subjects analysed
    49
    50
    Units: 0-11
    arithmetic mean (standard deviation)
        Week 1
    -0.50 ± 1.374
    -0.55 ± 1.268
        Week 2
    -0.73 ± 1.487
    -0.91 ± 1.623
        Week 3
    -0.84 ± 1.610
    -0.84 ± 1.884
    No statistical analyses for this end point

    Secondary: 30% Responder Rate in Oral LAT8881 Compared With Placebo, as Assessed by the Numeric Pain Rating Scale.

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    End point title
    30% Responder Rate in Oral LAT8881 Compared With Placebo, as Assessed by the Numeric Pain Rating Scale.
    End point description
    To determine the proportion of subjects with at least a 30% reduction in mean NPRS after 4 weeks treatment. The 11-point numeric pain rating scale (NPRS) ranges from 0 (“no pain”) to 10 (“worst pain imaginable”). A larger negative number represents a greater reduction in pain.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    LAT8881 Placebo
    Number of subjects analysed
    50
    50
    Units: Count of Participants
    20
    19
    No statistical analyses for this end point

    Secondary: 50% Responder Rate in Oral LAT8881 Compared With Placebo

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    End point title
    50% Responder Rate in Oral LAT8881 Compared With Placebo
    End point description
    To determine the proportion of subjects with at least a 50% reduction in mean the numeric pain rating scale (NPRS) after 4 weeks treatment. The 11-point numeric pain rating scale ranges from 0 (“no pain”) to 10 (“worst pain imaginable”). A larger negative number represents a greater reduction in pain.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    LAT8881 Placebo
    Number of subjects analysed
    50
    50
    Units: Count of Participants
    6
    9
    No statistical analyses for this end point

    Secondary: Maximum Change in Mean NPRS

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    End point title
    Maximum Change in Mean NPRS
    End point description
    To determine the maximum effects of oral LAT8881 in neuropathic pain, compared with placebo, as measured by the numeric pain rating scale (NPRS). The 11-point numeric pain rating scale ranges from 0 (“no pain”) to 10 (“worst pain imaginable”). A larger negative number represents a greater reduction in pain.
    End point type
    Secondary
    End point timeframe
    During the 4 week treatment period
    End point values
    LAT8881 Placebo
    Number of subjects analysed
    50
    50
    Units: 0-11
        arithmetic mean (standard deviation)
    -1.53 ± 1.372
    -1.55 ± 1.414
    No statistical analyses for this end point

    Secondary: Change in Functioning as Assessed by the Brief Pain Inventory Interference Scale (BPI)

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    End point title
    Change in Functioning as Assessed by the Brief Pain Inventory Interference Scale (BPI)
    End point description
    To evaluate the effects of oral LAT8881, compared with placebo, on functioning when measured by the Brief Pain Inventory Interference Scale (BPI). The BPI assesses the severity of pain and its impact on functioning. Patients are asked to assess the level of interference experienced across seven items; general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life, with a "0" meaning "no interference, and a "10", at the top end of the scale, meaning "complete interference". A reduction in mean score indicates a decrease in interference
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    LAT8881 Placebo
    Number of subjects analysed
    50
    50
    Units: 0-10
        arithmetic mean (standard deviation)
    -0.57 ± 1.833
    -1.12 ± 1.967
    No statistical analyses for this end point

    Secondary: Change in Pain Characteristics and Intensity, as Assessed by the Short Form McGill Pain Questionnaire (SF-MPQ-2)

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    End point title
    Change in Pain Characteristics and Intensity, as Assessed by the Short Form McGill Pain Questionnaire (SF-MPQ-2)
    End point description
    To evaluate the effect of oral LAT8881, compared with placebo, on pain symptoms in subjects with neuropathic pain, when measured by the Short Form McGill Pain Questionnaire (SF-MPQ-2). The SF-MPQ-2 contains 22 descriptors of pain and related symptoms, each scored from "0" (none) to "10" (worst possible). A larger negative number represents a greater reduction in pain.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    LAT8881 Placebo
    Number of subjects analysed
    50
    50
    Units: 0-11
        arithmetic mean (standard deviation)
    -0.66 ± 1.343
    -0.63 ± 1.701
    No statistical analyses for this end point

    Secondary: Change in Neuropathic Pain Symptoms, as Assessed by Neuropathic Pain Symptom Inventory (NPSI)

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    End point title
    Change in Neuropathic Pain Symptoms, as Assessed by Neuropathic Pain Symptom Inventory (NPSI)
    End point description
    The Neuropathic Pain Symptom Inventory (NPSI) contains ten items related to different pain descriptors (e.g. burning, squeezing, electric-shock, stabbing, tingling), allowing the assessment of the different dimensions of neuropathic pain, and two items related to the frequency and duration of pain. Each pain descriptor is rated on an 11-point numeric rating scale from 0 (no pain) to 10 (worst imaginable pain). Total pain intensity score is calculated by the sum of the 10 descriptors. A higher score indicates a higher pain intensity.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    LAT8881 Placebo
    Number of subjects analysed
    50
    50
    Units: 0-11
        arithmetic mean (standard deviation)
    -6.0 ± 14.52
    -7.4 ± 16.94
    No statistical analyses for this end point

    Secondary: Change in Emotional Functioning, as Assessed by the Beck Depression Inventory-II

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    End point title
    Change in Emotional Functioning, as Assessed by the Beck Depression Inventory-II
    End point description
    To evaluate the effect of oral LAT8881, compared with placebo, on emotional functioning when measured by the Beck Depression Inventory-II (BDI-II). The BDI-II consists of 21 items; each item is a list of four statements arranged in order of increasing severity about a particular symptom of depression. Each statement is scored from 0 to 3. Each of the 21 items is summed to give a single score for the BDI-II. Scores can range from 0 (no depression) to 63 (severe depression). An increase from baseline to the end of treatment indicates a deterioration.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    LAT8881 Placebo
    Number of subjects analysed
    50
    50
    Units: 0-63
        arithmetic mean (standard deviation)
    -1.1 ± 4.14
    -1.2 ± 7.98
    No statistical analyses for this end point

    Secondary: Patient Global Impression of Change Score

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    End point title
    Patient Global Impression of Change Score
    End point description
    The Patient Global Impression of Change (PGIC) is a a single-item rating by subjects of their improvement with treatment during a clinical trial. It asks the subject to rate their improvement with therapy on a 7-point scale, ranging from substantially worse ("0") to substantially improved ("7"), with no change ("4") as the mid-point. A score above 4 indicates an improvement.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    LAT8881 Placebo
    Number of subjects analysed
    50
    50
    Units: 0-7
        arithmetic mean (standard deviation)
    4.5 ± 1.23
    4.8 ± 1.33
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from the first dose of study treatment until the End of Study visit, maximum 93 days
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    LAT8881
    Reporting group description
    1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period

    Reporting group title
    Placebo
    Reporting group description
    1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period

    Serious adverse events
    LAT8881 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    LAT8881 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 51 (9.80%)
    6 / 51 (11.76%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 51 (3.92%)
    4 / 51 (7.84%)
         occurrences all number
    3
    4
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 51 (5.88%)
    3 / 51 (5.88%)
         occurrences all number
    4
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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