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    Clinical Trial Results:
    Assessment of Neublastin-Induced Skin and Sensory Alterations and Headache in Healthy Subjects and Migraine Patients

    Summary
    EudraCT number
    		 2019-001771-36
    Trial protocol
    		 NL  
    Global end of trial date
    30 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Apr 2022
    First version publication date
    18 Apr 2022
    Other versions
    Summary report(s)
    		 Summary of M2. CHDR1755_CSR

    Trial information

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    Trial identification
    Sponsor protocol code
    CHDR1755
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centre for Human Drug Research
    Sponsor organisation address
    Zernikedreef 8, Leiden, Netherlands, 2333 CL
    Public contact
    Principal Investigator, Centre for Human Drug Research, +31 715246400, clintrials@chdr.nl
    Scientific contact
    Principal Investigator, Centre for Human Drug Research, +31 715246400, clintrials@chdr.nl
    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
    30 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Sep 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objectives 1. To assess pruritus and rash after administration of Neublastin or placebo in healthy subjects and migraine patients (Parts A and B) 2. To assess headache and other migraine-associated symptoms after administration of Neublastin or placebo in migraine patients (Part B)
    Protection of trial subjects
    To protect trial participants, the following safety measures were taken. Pre-dose and regular post-dose measurement of: - Adverse events - Vital signs (pulse rate, blood pressure, respiration rate) - Body temperature - ECG - Hematology blood sample - Chemistry blood sample - Urinalysis
    Background therapy
    		 Migraine treatment NSAIDS and/or triptans (Part B)
    Evidence for comparator
    		 A double-blinded and placebo-controlled design was deemed appropriate because of the pharmacodynamic assessments that were performed in this study. By blinding the study, bias arising from investigator’s knowledge about treatment assignment on interpretation of the data was avoided.
    Actual start date of recruitment
    16 Aug 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
    Netherlands: 48
    Worldwide total number of subjects
    48
    EEA total number of subjects
    48
    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)
    48
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment from July 2019- July 2020. Location: Netherlands

    Pre-assignment
    Screening details
    		 Healthy male or female subjects, 18-65 years of age (inclusive), without evidence of any active or chronic illness or any clinically significant abnormalities in laboratory test results, ECG and blood pressure.

    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
    The investigational drug and the matching placebo were visually indistinguishable and were packaged and administered in the same way. Treatment and placebo were labelled with the subject’s randomization number only.

    Arms
    Arm title
    		 Neublastin treatment
    Arm description
    		 Part A (n=36) • Cohort 1 (n=24): single intravenous administration of 150 μg/kg Neublastin (n=12) or placebo (n=12). • Cohort 2 (n=12): single intradermal administration of 5 μg (n=3), 20 μg (n=3) or 100 μg (n=6) Neublastin in the left or right leg and matching placebo in the opposite leg. All subjects in cohort 2 also received an ID dose of Neublastin in the flank or upper back area. Part B (n=12) • Single intravenous administration of 50 μg/kg (n=6) or 150 μg/kg (n=6) Neublastin and matching placebo.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Neublasting
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intradermal use, Intravenous use
    Dosage and administration details
    1.6 mg/ml solution for both IV infusion and ID injection.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intradermal use, Intravenous use
    Dosage and administration details
    0.9% sodium chloride solution.

    Number of subjects in period 1
    		Neublastin treatment
    Started
    48
    Completed
    48

    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
    		 48 48
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 48 48
    Gender categorical
    Units: Subjects
        Female
    		 33 33
        Male
    		 15 15

    End points

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    End points reporting groups
    Reporting group title
    Neublastin treatment
    Reporting group description
    		 Part A (n=36) • Cohort 1 (n=24): single intravenous administration of 150 μg/kg Neublastin (n=12) or placebo (n=12). • Cohort 2 (n=12): single intradermal administration of 5 μg (n=3), 20 μg (n=3) or 100 μg (n=6) Neublastin in the left or right leg and matching placebo in the opposite leg. All subjects in cohort 2 also received an ID dose of Neublastin in the flank or upper back area. Part B (n=12) • Single intravenous administration of 50 μg/kg (n=6) or 150 μg/kg (n=6) Neublastin and matching placebo.

    Primary: Assessment of pruritus and rash (Part A and B) and headache (Part B)

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    End point title
    		 Assessment of pruritus and rash (Part A and B) and headache (Part B) [1]
    End point description
    Part A and B: • The assessment of pruritus (incidence, intensity, severity and duration) in healthy subjects and migraine patients over a 28-day period after challenge with Neublastin or placebo (ID and IV) as measured by the Pruritus Assessment questionnaire and 5-D Pruritus Scale questionnaire. • The assessment of rash (incidence, area and severity, and qualitative assessments) in healthy subjects and migraine patients over a 28-day period after challenge with Neublastin or placebo (ID and IV) as measured by the Rash Assessment questionnaire, Eczema Area and Severity Index (EASI), patient-reported SCORing Atopic Dermatitis (PO-SCORAD) score, Erythema index and digital photography of rash. Part B: • The assessment of headache (incidence, severity, duration and incidence of migraine-associated symptoms) in migraine patients over a 28-day period after challenge with Neublastin or placebo (IV) as measured by the Headache Assessment questionnaire.
    End point type
    Primary
    End point timeframe
    28-day period
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: For endpoints and analyses see attached CSR summary.
    End point values
    		 Neublastin treatment
    Number of subjects analysed
    48
    Units: questionnaire
    48
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening (up to 28 days before dosing) until follow-up visits Day 28 (Part A) and Day 56 (Part B)
    Adverse event reporting additional description
    Adverse events were investigated by the investigator routinely on all study visits and AE intensity, relationship to study intervention, chronicity and eventual actions related to the AE were determined.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Neublastin treatment
    Reporting group description
    		 Part A (n=36) • Cohort 1 (n=24): single intravenous administration of 150 μg/kg Neublastin (n=12) or placebo (n=12). • Cohort 2 (n=12): single intradermal administration of 5 μg (n=3), 20 μg (n=3) or 100 μg (n=6) Neublastin in the left or right leg and matching placebo in the opposite leg. All subjects in cohort 2 also received an ID dose of Neublastin in the flank or upper back area. Part B (n=12) • Single intravenous administration of 50 μg/kg (n=6) or 150 μg/kg (n=6) Neublastin and matching placebo.

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Neublastin treatment Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax spontaneous
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Neublastin treatment Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 48 (50.00%)
    12 / 48 (25.00%)
    Nervous system disorders
    headache
         subjects affected / exposed
    14 / 48 (29.17%)
    12 / 48 (25.00%)
         occurrences all number
    17
    15
    Migraine
         subjects affected / exposed
    7 / 48 (14.58%)
    9 / 48 (18.75%)
         occurrences all number
    18
    11
    General disorders and administration site conditions
    Feeling hot
         subjects affected / exposed
    6 / 48 (12.50%)
    1 / 48 (2.08%)
         occurrences all number
    6
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    14 / 48 (29.17%)
    0 / 48 (0.00%)
         occurrences all number
    21
    0
    Rash pruritic
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Erythema
         subjects affected / exposed
    14 / 48 (29.17%)
    0 / 48 (0.00%)
         occurrences all number
    17
    0
    rash
         subjects affected / exposed
    3 / 48 (6.25%)
    0 / 48 (0.00%)
         occurrences all number
    3
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Sep 2019
    Change of dose.
    24 Dec 2019
    Change of dose.
    16 Jun 2020
    Restart of clinical study activities related to the COVID-19 pandemic.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    13 Mar 2020
    Covid-19 pandemic.
    26 Jun 2020

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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