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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled Single-Ascending Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of GWP42003-P in Conjunction with Hypothermia in Neonates with Moderate or Severe Hypoxic Ischemic Encephalopathy

    Summary
    EudraCT number
    		 2016-000936-17
    Trial protocol
    		 GB   ES   PL  
    Global end of trial date
    01 Jun 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2022
    First version publication date
    16 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GWEP1560
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GW Research Ltd
    Sponsor organisation address
    Sovereign House, Vision Park, Histon, Cambridge, United Kingdom, CB24 9BZ
    Public contact
    Clinical Trial Disclosure & Transparency, GW Research Ltd, +1 215-832-3750, ClinicalTrialDisclosure@JazzPharma.com
    Scientific contact
    Clinical Trial Disclosure & Transparency, GW Research Ltd, +1 215-832-3750, ClinicalTrialDisclosure@JazzPharma.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
    01 Jun 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of a single-ascending intravenous (IV) dose of GWP42003-P compared with placebo in neonates (minimum of 36 weeks plus 0 days gestational age) who are undergoing whole-body hypothermia (standard of care) for the treatment of NHIE.
    Protection of trial subjects
    This study was conducted in accordance with the protocol and consensus ethical principles derived from international guidelines including the Declaration of Helsinki, Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice, and other applicable laws and regulations. The protocol, protocol amendments, informed consent form, Investigator's Brochure, and other relevant documents were reviewed and approved by the Institutional Review Board/Independent Ethics Committee prior to study initiation.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Jan 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    United Kingdom: 8
    Worldwide total number of subjects
    13
    EEA total number of subjects
    5
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    1
    Newborns (0-27 days)
    12
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 13 patients who met all inclusion criteria and no exclusion criteria were randomized to receive a single dose of GWP42003-P (0.1 mg/kg, 0.3 mg/kg, or 1.0 mg/kg) at 8 clinic centers in Poland, Spain, and United Kingdom.

    Pre-assignment
    Screening details
    		 Eligible patients were randomized to receive a single IV dose of GWP42003-P or placebo as soon as possible after the required core temperature for whole-body hypothermia had been achieved and within 18 hours of birth.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GWP42003-P 0.1 mg/kg
    Arm description
    		 Patients with neonatal hypoxic-ischemic encephalopathy (NHIE) who received whole-body hypothermia as standard of care were randomized to receive a single intravenous (IV) dose of GWP42003-P 0.1 mg/kg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GWP42003-P
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    GWP42003-P was administered as a single 15-minute IV infusion using an infusion pump as soon as possible after the required core temperature for whole-body hypothermia had been achieved and within 18 hours of birth.

    Arm title
    		 GWP42003-P 0.3 mg/kg
    Arm description
    		 Patients with neonatal hypoxic-ischemic encephalopathy (NHIE) who received whole-body hypothermia as standard of care were randomized to receive a single intravenous (IV) dose of GWP42003-P 0.3 mg/kg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GWP42003-P
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    GWP42003-P was administered as a single 15-minute IV infusion using an infusion pump as soon as possible after the required core temperature for whole-body hypothermia had been achieved and within 18 hours of birth.

    Arm title
    		 GWP42003-P 1.0 mg/kg
    Arm description
    		 Patients with neonatal hypoxic-ischemic encephalopathy (NHIE) who received whole-body hypothermia as standard of care were randomized to receive a single intravenous (IV) dose of GWP42003-P 1.0 mg/kg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GWP42003-P
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    GWP42003-P was administered as a single 15-minute IV infusion using an infusion pump as soon as possible after the required core temperature for whole-body hypothermia had been achieved and within 18 hours of birth.

    Arm title
    		 Pooled Placebo
    Arm description
    		 All patients with neonatal hypoxic-ischemic encephalopathy (NHIE) who received whole-body hypothermia as standard of care were randomized to receive a single intravenous (IV) dose of placebo-matched treatment.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo was administered as a single 15-minute IV infusion using an infusion pump as soon as possible after the required core temperature for whole-body hypothermia had been achieved and within 18 hours of birth.

    Number of subjects in period 1
    		GWP42003-P 0.1 mg/kg GWP42003-P 0.3 mg/kg GWP42003-P 1.0 mg/kg Pooled Placebo
    Started
    3
    3
    3
    4
    Completed
    3
    2
    3
    3
    Not completed
    0
    1
    0
    1
         Lost to follow-up
    -
    1
    -
    -
         Sponsor decision
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GWP42003-P 0.1 mg/kg
    Reporting group description
    		 Patients with neonatal hypoxic-ischemic encephalopathy (NHIE) who received whole-body hypothermia as standard of care were randomized to receive a single intravenous (IV) dose of GWP42003-P 0.1 mg/kg.

    Reporting group title
    GWP42003-P 0.3 mg/kg
    Reporting group description
    		 Patients with neonatal hypoxic-ischemic encephalopathy (NHIE) who received whole-body hypothermia as standard of care were randomized to receive a single intravenous (IV) dose of GWP42003-P 0.3 mg/kg.

    Reporting group title
    GWP42003-P 1.0 mg/kg
    Reporting group description
    		 Patients with neonatal hypoxic-ischemic encephalopathy (NHIE) who received whole-body hypothermia as standard of care were randomized to receive a single intravenous (IV) dose of GWP42003-P 1.0 mg/kg.

    Reporting group title
    Pooled Placebo
    Reporting group description
    		 All patients with neonatal hypoxic-ischemic encephalopathy (NHIE) who received whole-body hypothermia as standard of care were randomized to receive a single intravenous (IV) dose of placebo-matched treatment.

    Reporting group values
    		 GWP42003-P 0.1 mg/kg GWP42003-P 0.3 mg/kg GWP42003-P 1.0 mg/kg Pooled Placebo Total
    Number of subjects
    		 3 3 3 4 13
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 1 0 0 0 1
        Newborns (0-27 days)
    		 2 3 3 4 12
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Age at randomization (hours)
    Units: hours
        arithmetic mean (standard deviation)
    		 9.44 ± 1.11 8.68 ± 0.91 10.23 ± 3.98 10.86 ± 0.75 -
    Gender categorical
    Units: Subjects
        Female
    		 0 1 3 2 6
        Male
    		 3 2 0 2 7

    End points

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    End points reporting groups
    Reporting group title
    GWP42003-P 0.1 mg/kg
    Reporting group description
    		 Patients with neonatal hypoxic-ischemic encephalopathy (NHIE) who received whole-body hypothermia as standard of care were randomized to receive a single intravenous (IV) dose of GWP42003-P 0.1 mg/kg.

    Reporting group title
    GWP42003-P 0.3 mg/kg
    Reporting group description
    		 Patients with neonatal hypoxic-ischemic encephalopathy (NHIE) who received whole-body hypothermia as standard of care were randomized to receive a single intravenous (IV) dose of GWP42003-P 0.3 mg/kg.

    Reporting group title
    GWP42003-P 1.0 mg/kg
    Reporting group description
    		 Patients with neonatal hypoxic-ischemic encephalopathy (NHIE) who received whole-body hypothermia as standard of care were randomized to receive a single intravenous (IV) dose of GWP42003-P 1.0 mg/kg.

    Reporting group title
    Pooled Placebo
    Reporting group description
    		 All patients with neonatal hypoxic-ischemic encephalopathy (NHIE) who received whole-body hypothermia as standard of care were randomized to receive a single intravenous (IV) dose of placebo-matched treatment.

    Primary: An Overview of Safety Summary in Neonatal Patients Who Received GWP42003-P or Matching Placebo

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    End point title
    		 An Overview of Safety Summary in Neonatal Patients Who Received GWP42003-P or Matching Placebo [1]
    End point description
    An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Serious AEs are any AE that: results in death, is life threatening, or places the patient at immediate risk of death from the event as it occurred, requires or prolongs hospitalization, causes persistent or significant disability or incapacity, or results in congenital anomalies or birth defects.
    End point type
    Primary
    End point timeframe
    Consent (screening) up to and including the post-trial follow-up visit at Day 30
    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: No statistical analyses for this endpoint.
    End point values
    		 GWP42003-P 0.1 mg/kg GWP42003-P 0.3 mg/kg GWP42003-P 1.0 mg/kg Pooled Placebo
    Number of subjects analysed
    3
    3
    3
    4
    Units: Number of AEs
    number (not applicable)
        Any AE
    12
    7
    9
    16
        Mild AE
    4
    6
    7
    13
        Moderate AE
    7
    0
    2
    3
        Severe AE
    1
    1
    0
    0
        Study-drug related AE
    1
    0
    1
    2
        AEs that led to study withdrawal
    0
    0
    0
    0
        Serious AE
    0
    1
    0
    0
    No statistical analyses for this end point

    Primary: Mortality Rate in Neonatal Patients Who Received GWP42003-P or Matching Placebo

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    End point title
    		 Mortality Rate in Neonatal Patients Who Received GWP42003-P or Matching Placebo [2]
    End point description
    Mortality was defined as death due to any cause.
    End point type
    Primary
    End point timeframe
    Randomization up to Day 30
    Notes
    [2] - 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: No statistical analyses for this endpoint.
    End point values
    		 GWP42003-P 0.1 mg/kg GWP42003-P 0.3 mg/kg GWP42003-P 1.0 mg/kg Pooled Placebo
    Number of subjects analysed
    3
    3
    3
    4
    Units: Number of patients
    number (not applicable)
        Death
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Change From Baseline to Day 10 in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase in Neonatal Patients Who Received GWP42003-P or Matching Placebo

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    End point title
    		 Change From Baseline to Day 10 in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase in Neonatal Patients Who Received GWP42003-P or Matching Placebo [3]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline up to Day 10
    Notes
    [3] - 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: No statistical analyses for this endpoint.
    End point values
    		 GWP42003-P 0.1 mg/kg GWP42003-P 0.3 mg/kg GWP42003-P 1.0 mg/kg Pooled Placebo
    Number of subjects analysed
    2 [4]
    1 [5]
    1 [6]
    1 [7]
    Units: Units/liter
    median (full range (min-max))
        Alkaline phosphatase
    31.0 (31.0 to 31.0)
    -2.0 (-2.0 to -2.0)
    0 (0 to 0)
    0 (0 to 0)
        Alanine aminotransferase
    -15.0 (-21.0 to -9.0)
    -103.0 (-103.0 to -103.0)
    -65.0 (-65.0 to -65.0)
    11.0 (11.0 to 11.0)
        Aspartate aminotransferase
    -139.0 (-139.0 to -139.0)
    0 (0 to 0)
    -122.0 (-122.0 to -122.0)
    0 (0 to 0)
    Notes
    [4] - Alkaline phosphatase n=1; ALT n= 2; AST n=1
    [5] - Alkaline phosphatase n=1; ALT n= 1; AST n=0 If 0 (0,0) is reported, it indicates missing values.
    [6] - Alkaline phosphatase n=0; ALT n= 1; AST n=1 If 0 (0,0) is reported, it indicates missing values.
    [7] - Alk phos n=1; ALT n= 1; AST n=0 0 (0,0) indicates missing values, except Alk phos where 0 is value
    No statistical analyses for this end point

    Primary: Change From Baseline to Day 10 in Total Bilirubin and Creatinine in Neonatal Patients Who Received GWP42003-P or Matching Placebo

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    End point title
    		 Change From Baseline to Day 10 in Total Bilirubin and Creatinine in Neonatal Patients Who Received GWP42003-P or Matching Placebo [8]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline up to Day 10
    Notes
    [8] - 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: No statistical analyses for this endpoint.
    End point values
    		 GWP42003-P 0.1 mg/kg GWP42003-P 0.3 mg/kg GWP42003-P 1.0 mg/kg Pooled Placebo
    Number of subjects analysed
    2 [9]
    1 [10]
    0 [11]
    1
    Units: micromole/liter
    median (full range (min-max))
        Total bilirubin
    16.0 (8.0 to 24.0)
    0 (0 to 0)
    ( to )
    168.0 (168.0 to 168.0)
        Creatinine
    -27.0 (-27.0 to -27.0)
    -31.0 (-31.0 to -31.0)
    ( to )
    -2.0 (-2.0 to -2.0)
    Notes
    [9] - Total bilirubin n=2; Creatinine n=1
    [10] - Total bilirubin n=0; Creatinine n=1 If 0 (0,0) is reported, it indicates missing values.
    [11] - Total bilirubin and creatinine were not assessed in this group.
    No statistical analyses for this end point

    Primary: Change From Baseline to Day 10 in pH in Neonatal Patients Who Received GWP42003-P or Matching Placebo

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    End point title
    		 Change From Baseline to Day 10 in pH in Neonatal Patients Who Received GWP42003-P or Matching Placebo [12]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline up to Day 10
    Notes
    [12] - 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: No statistical analyses for this endpoint.
    End point values
    		 GWP42003-P 0.1 mg/kg GWP42003-P 0.3 mg/kg GWP42003-P 1.0 mg/kg Pooled Placebo
    Number of subjects analysed
    2
    0 [13]
    0 [14]
    0 [15]
    Units: logarithmic units
        median (full range (min-max))
    0.180 (0.080 to 0.280)
    ( to )
    ( to )
    ( to )
    Notes
    [13] - pH was not assessed in this group.
    [14] - pH was not assessed in this group.
    [15] - pH was not assessed in this group.
    No statistical analyses for this end point

    Primary: Change From Baseline to Day 10 in Hemoglobin in Neonatal Patients Who Received GWP42003-P or Matching Placebo

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    End point title
    		 Change From Baseline to Day 10 in Hemoglobin in Neonatal Patients Who Received GWP42003-P or Matching Placebo [16]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline up to Day 10
    Notes
    [16] - 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: No statistical analyses for this endpoint.
    End point values
    		 GWP42003-P 0.1 mg/kg GWP42003-P 0.3 mg/kg GWP42003-P 1.0 mg/kg Pooled Placebo
    Number of subjects analysed
    2
    0 [17]
    1
    1
    Units: g/L
        median (full range (min-max))
    -77.5 (-130.0 to -25.0)
    ( to )
    -10.0 (-10.0 to -10.0)
    -9.0 (-9.0 to -9.0)
    Notes
    [17] - Hemoglobin was not assessed in this group.
    No statistical analyses for this end point

    Primary: Change From Baseline to Day 10 in Platelets and Leukocytes in Neonatal Patients Who Received GWP42003-P or Matching Placebo

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    End point title
    		 Change From Baseline to Day 10 in Platelets and Leukocytes in Neonatal Patients Who Received GWP42003-P or Matching Placebo [18]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline up to Day 10
    Notes
    [18] - 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: No statistical analyses for this endpoint.
    End point values
    		 GWP42003-P 0.1 mg/kg GWP42003-P 0.3 mg/kg GWP42003-P 1.0 mg/kg Pooled Placebo
    Number of subjects analysed
    2
    0 [19]
    1
    1
    Units: 10^9/liter
    median (full range (min-max))
        Platelets
    -84.0 (-85.0 to -83.0)
    ( to )
    46.0 (46.0 to 46.0)
    24.0 (24.0 to 24.0)
        Leukocytes
    -8.2 (-16.1 to -0.3)
    ( to )
    -12.6 (-12.6 to -12.6)
    -11.8 (-11.8 to -11.8)
    Notes
    [19] - Platelets and leukocytes were not assessed in this group.
    No statistical analyses for this end point

    Primary: Median Diastolic and Systolic Blood Pressure Levels in Neonatal Patients Who Received GWP42003-P or Matching Placebo

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    End point title
    		 Median Diastolic and Systolic Blood Pressure Levels in Neonatal Patients Who Received GWP42003-P or Matching Placebo [20]
    End point description
    End point type
    Primary
    End point timeframe
    1 hour after birth up to Visit 7 (discharge from NICU)
    Notes
    [20] - 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: No statistical analyses for this endpoint.
    End point values
    		 GWP42003-P 0.1 mg/kg GWP42003-P 0.3 mg/kg GWP42003-P 1.0 mg/kg Pooled Placebo
    Number of subjects analysed
    3 [21]
    3 [22]
    3 [23]
    4 [24]
    Units: mmHg
    median (full range (min-max))
        Diastolic: 1 hour after birth
    29.5 (26 to 33)
    32.0 (30 to 50)
    0 (0 to 0)
    37.5 (32 to 43)
        Diastolic: 8 hours after birth
    47.0 (40 to 49)
    39.0 (35 to 43)
    46.0 (46 to 46)
    35.0 (33 to 37)
        Diastolic: 12 hours after birth
    40.0 (36 to 54)
    46.0 (40 to 50)
    39.0 (31 to 47)
    37.5 (36 to 47)
        Diastolic: 24 hours after birth
    41.0 (30 to 52)
    36.5 (25 to 48)
    40.0 (34 to 42)
    31.0 (20 to 34)
        Diastolic: 36 hours after birth
    41.0 (30 to 52)
    47.0 (44 to 51)
    40.0 (36 to 47)
    34.0 (32 to 37)
        Diastolic: 48 hours after birth
    44.0 (36 to 52)
    46.0 (43 to 48)
    41.0 (35 to 44)
    36.5 (30 to 48)
        Diastolic:60 hours after birth
    42.0 (39 to 48)
    41.0 (38 to 64)
    37.0 (34 to 41)
    45.0 (35 to 54)
        Diastolic: 72 hours after birth
    46.0 (30 to 48)
    49.0 (32 to 66)
    43.0 (40 to 46)
    36.0 (16 to 56)
        Diastolic: 96 hours after birth
    42.5 (42 to 43)
    42.0 (38 to 46)
    28.0 (26 to 42)
    33.0 (30 to 41)
        Diastolic: 108 hours after birth
    47.0 (45 to 49)
    51.0 (27 to 53)
    40.0 (33 to 51)
    40.5 (29 to 48)
        Diastolic: 120 hours after birth
    44.0 (44 to 44)
    46.0 (46 to 46)
    56.0 (56 to 56)
    59.0 (59 to 59)
        Diastolic: Visit 7 (Discharge from NICU)
    44.0 (39 to 45)
    51.0 (51 to 51)
    43.0 (39 to 55)
    48.0 (48 to 48)
        Systolic: 1 hour after birth
    63.0 (56 to 70)
    69.0 (62 to 88)
    0 (0 to 0)
    63.0 (61 to 65)
        Systolic: 8 hours after birth
    65.0 (61 to 79)
    70.0 (62 to 78)
    74.0 (74 to 74)
    65.0 (59 to 71)
        Systolic: 12 hours after birth
    53.0 (52 to 79)
    70.0 (66 to 70)
    68.0 (60 to 76)
    66.0 (63 to 75)
        Systolic: 24 hours after birth
    56.5 (42 to 71)
    57.5 (54 to 61)
    54.0 (53 to 66)
    51.0 (50 to 52)
        Systolic: 36 hours after birth
    61.0 (50 to 72)
    63.0 (60 to 74)
    66.0 (61 to 73)
    57.0 (45 to 64)
        Systolic: 48 hours after birth
    60.5 (50 to 71)
    62.0 (59 to 71)
    70.0 (53 to 73)
    61.5 (59 to 62)
        Systolic: 60 hours after birth
    67.0 (55 to 72)
    60.0 (54 to 80)
    63.0 (53 to 64)
    71.5 (61 to 79)
        Systolic: 72 hours after birth
    55.0 (46 to 76)
    67.0 (55 to 79)
    69.5 (66 to 73)
    72.5 (62 to 82)
        Systolic: 96 hours after birth
    63.0 (52 to 74)
    74.0 (72 to 75)
    71.0 (56 to 74)
    64.0 (57 to 70)
        Systolic: 108 hours after birth
    73.0 (70 to 76)
    77.0 (67 to 82)
    68.0 (62 to 78)
    67.0 (58 to 72)
        Systolic: 120 hours after birth
    77.0 (77 to 77)
    72.0 (72 to 72)
    71.0 (71 to 71)
    90.0 (90 to 90)
        Systolic: Visit 7 (Discharge from NICU)
    85.0 (80 to 86)
    81.0 (81 to 81)
    80.0 (64 to 92)
    84.0 (84 to 84)
    Notes
    [21] - N's varied by timepoint
    [22] - N's varied by timepoint
    [23] - N's varied by timepoint If 0 (0,0) is reported, it indicates missing values.
    [24] - N's varied by timepoint
    No statistical analyses for this end point

    Primary: Median Pulse Rate in Neonatal Patients Who Received GWP42003-P or Matching Placebo

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    End point title
    		 Median Pulse Rate in Neonatal Patients Who Received GWP42003-P or Matching Placebo [25]
    End point description
    End point type
    Primary
    End point timeframe
    1 hour after birth up to Visit 7 (discharge from NICU)
    Notes
    [25] - 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: No statistical analyses for this endpoint.
    End point values
    		 GWP42003-P 0.1 mg/kg GWP42003-P 0.3 mg/kg GWP42003-P 1.0 mg/kg Pooled Placebo
    Number of subjects analysed
    3 [26]
    3 [27]
    3 [28]
    4 [29]
    Units: beats/minute
    median (full range (min-max))
        1 hour after birth
    139.0 (111 to 140)
    142.0 (132 to 152)
    130.0 (130 to 130)
    100.0 (100 to 136)
        8 hours after birth
    89.0 (84 to 150)
    109.0 (96 to 113)
    99.0 (92 to 106)
    115.5 (101 to 130)
        12 hours after birth
    107.0 (93 to 140)
    101.0 (98 to 116)
    111.0 (80 to 167)
    97.0 (89 to 99)
        24 hours after birth
    109.5 (89 to 130)
    101.0 (101 to 101)
    107.0 (72 to 141)
    101.0 (90 to 111)
        36 hours after birth
    92.0 (92 to 120)
    110.0 (99 to 132)
    109.0 (71 to 147)
    102.5 (85 to 123)
        48 hours after birth
    100.0 (94 to 140)
    122.0 (99 to 132)
    99.0 (80 to 137)
    104.0 (101 to 121)
        60 hours after birth
    100.0 (90 to 107)
    108.0 (107 to 116)
    88.0 (78 to 111)
    97.5 (87 to 125)
        72 hours after birth
    111.0 (89 to 120)
    101.0 (99 to 111)
    92.0 (85 to 107)
    98.0 (68 to 128)
        96 hours after birth
    132.0 (128 to 140)
    137.0 (128 to 145)
    133.0 (119 to 161)
    130.0 (122 to 144)
        108 hours after birth
    128.0 (120 to 140)
    124.0 (123 to 143)
    126.0 (118 to 138)
    135.5 (131 to 138)
        120 hours after birth
    128.0 (128 to 128)
    134.0 (134 to 134)
    126.0 (111 to 141)
    109.0 (95 to 123)
        Visit 7 (Discharge after NICU)
    137.0 (118 to 154)
    132.0 (126 to 138)
    117.0 (107 to 142)
    128.0 (128 to 144)
    Notes
    [26] - N's varied by timepoint
    [27] - N's varied by timepoint
    [28] - N's varied by timepoint
    [29] - N's varied by timepoint
    No statistical analyses for this end point

    Primary: Median Oxygen Saturation in Neonatal Patients Who Received GWP42003-P or Matching Placebo

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    End point title
    		 Median Oxygen Saturation in Neonatal Patients Who Received GWP42003-P or Matching Placebo [30]
    End point description
    End point type
    Primary
    End point timeframe
    1 hour after birth up to Visit 7 (discharge from NICU)
    Notes
    [30] - 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: No statistical analyses for this endpoint.
    End point values
    		 GWP42003-P 0.1 mg/kg GWP42003-P 0.3 mg/kg GWP42003-P 1.0 mg/kg Pooled Placebo
    Number of subjects analysed
    3 [31]
    3 [32]
    3 [33]
    4 [34]
    Units: percentage of oxygen saturation
    median (full range (min-max))
        1 hour after birth
    96.0 (90 to 98)
    100.0 (90 to 100)
    95.0 (95 to 95)
    97.0 (89 to 100)
        8 hours after birth
    99.0 (94 to 100)
    98.0 (95 to 100)
    100.0 (100 to 100)
    95.5 (95 to 96)
        12 hours after birth
    97.0 (94 to 100)
    97.0 (94 to 98)
    97.0 (93 to 98)
    98.0 (94 to 100)
        24 hours after birth
    94.0 (90 to 98)
    100.0 (100 to 100)
    100.0 (98 to 100)
    99.0 (97 to 100)
        36 hours after birth
    100.0 (100 to 100)
    99.0 (93 to 100)
    100.0 (95 to 100)
    97.5 (95 to 100)
        48 hours after birth
    100.0 (90 to 100)
    100.0 (100 to 100)
    99.0 (98 to 100)
    98.5 (91 to 99)
        60 hours after birth
    99.0 (96 to 100)
    100.0 (97 to 100)
    98.0 (97 to 100)
    98.0 (94 to 99)
        72 hours after birth
    96.0 (96 to 100)
    100.0 (96 to 100)
    100.0 (99 to 100)
    98.5 (95 to 100)
        96 hours after birth
    99.0 (98 to 100)
    100.0 (97 to 100)
    97.0 (97 to 100)
    95.5 (95 to 100)
        108 hours after birth
    99.0 (91 to 100)
    100.0 (99 to 100)
    98.0 (98 to 98)
    97.0 (96 to 98)
        120 hours after birth
    100.0 (100 to 100)
    100.0 (100 to 100)
    98.0 (97 to 99)
    94.5 (93 to 96)
        Visit 7 (Discharge from NICU)
    100.0 (98 to 100)
    0 (0 to 0)
    100.0 (99 to 100)
    97.0 (95 to 99)
    Notes
    [31] - N's varied by timepoint
    [32] - N's varied by timepoint If 0 (0,0) is reported, it indicates missing values.
    [33] - N's varied by timepoint
    [34] - N's varied by timepoint
    No statistical analyses for this end point

    Primary: Change From Baseline to Day 10 in Calcium in Neonatal Patients Who Received GWP42003-P or Matching Placebo

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    End point title
    		 Change From Baseline to Day 10 in Calcium in Neonatal Patients Who Received GWP42003-P or Matching Placebo [35]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline up to Day 10
    Notes
    [35] - 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: No statistical analyses for this endpoint.
    End point values
    		 GWP42003-P 0.1 mg/kg GWP42003-P 0.3 mg/kg GWP42003-P 1.0 mg/kg Pooled Placebo
    Number of subjects analysed
    1
    0 [36]
    0 [37]
    0 [38]
    Units: millimole/liter
    median (full range (min-max))
        Calcium
    0.86 (0.86 to 0.86)
    ( to )
    ( to )
    ( to )
    Notes
    [36] - Calcium was not assessed in the group.
    [37] - Calcium was not assessed in this group.
    [38] - Calcium was not assessed in this group.
    No statistical analyses for this end point

    Primary: Median Cardiorespiratory Values in Neonatal Patients Who Received GWP42003-P or Matching Placebo

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    End point title
    		 Median Cardiorespiratory Values in Neonatal Patients Who Received GWP42003-P or Matching Placebo [39]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline up to 96–120 hours postnatal
    Notes
    [39] - 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: No statistical analyses for this endpoint.
    End point values
    		 GWP42003-P 0.1 mg/kg GWP42003-P 0.3 mg/kg GWP42003-P 1.0 mg/kg Pooled Placebo
    Number of subjects analysed
    3 [40]
    3 [41]
    3 [42]
    4 [43]
    Units: Age (hours)
    median (full range (min-max))
        Age at initiation of whole-body hypothermia
    2.45 (0.70 to 3.63)
    2.42 (1.25 to 3.18)
    0.50 (0.33 to 4.78)
    0.85 (0.08 to 1.17)
        Age at hypothermia established
    3.28 (1.98 to 4.88)
    3.08 (1.58 to 3.68)
    3.78 (2.50 to 4.78)
    2.90 (0.17 to 5.00)
        Age at deviations outside acceptable hypothermia
    39.90 (21.42 to 58.38)
    19.18 (19.18 to 19.18)
    11.53 (11.53 to 11.53)
    0 (0 to 0)
        Age at reinitiation of rewarming
    75.28 (72.92 to 75.63)
    75.18 (73.58 to 75.25)
    76.53 (74.75 to 76.78)
    77.36 (73.57 to 80.67)
        Age at normothermia achieved
    83.38 (83.28 to 83.92)
    85.18 (82.75 to 86.58)
    83.53 (82.50 to 86.25)
    83.36 (80.07 to 87.67)
    Notes
    [40] - N=2 for Age at deviations outside the acceptable hypothermic range start
    [41] - N=1 for Age at deviations outside the acceptable hypothermic range start
    [42] - N=1 for Age at deviations outside the acceptable hypothermic range start
    [43] - N=0; Age at deviations outside acceptable hypothermic range start 0 (0,0) indicates missing values
    No statistical analyses for this end point

    Primary: Number of Patients With Whole-Body Hypothermia Deviations in Neonatal Patients Who Received GWP42003-P or Matching Placebo

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    End point title
    		 Number of Patients With Whole-Body Hypothermia Deviations in Neonatal Patients Who Received GWP42003-P or Matching Placebo [44]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline up to 96–120 hours postnatal
    Notes
    [44] - 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: No statistical analyses for this endpoint.
    End point values
    		 GWP42003-P 0.1 mg/kg GWP42003-P 0.3 mg/kg GWP42003-P 1.0 mg/kg Pooled Placebo
    Number of subjects analysed
    3
    3
    3
    4
    Units: Number of patients
    number (not applicable)
        Patients with whole-body hypothermia deviations
    2
    1
    1
    0
    No statistical analyses for this end point

    Secondary: Mean Whole Blood Concentration of Cannibidiol in Neonatal Patients Who Received GWP42300-P

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    End point title
    		 Mean Whole Blood Concentration of Cannibidiol in Neonatal Patients Who Received GWP42300-P [45]
    End point description
    Whole blood concentrations of cannibidiol were assessed from blood samples at end of infusion and at 1, 2, 4, and 8 hours after end of infusion.
    End point type
    Secondary
    End point timeframe
    End of infusion up to 8 hours after end of infusion
    Notes
    [45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses for this endpoint.
    End point values
    		 GWP42003-P 0.1 mg/kg GWP42003-P 0.3 mg/kg GWP42003-P 1.0 mg/kg
    Number of subjects analysed
    3 [46]
    3 [47]
    3 [48]
    Units: ng/mL
    arithmetic mean (standard deviation)
        End of infusion
    46.77 ± 21.21
    114.67 ± 11.59
    456.00 ± 118.90
        1 hour after end of infusion
    11.07 ± 5.67
    22.75 ± 2.62
    94.95 ± 9.97
        2 hours after end of infusion
    7.50 ± 3.35
    16.65 ± 0.35
    65.67 ± 20.74
        4 hours after end of infusion
    4.74 ± 1.87
    6.44 ± 2.77
    40.55 ± 6.44
        8 hours after end of infusion
    1.80 ± 0.38
    2.47 ± 1.33
    12.65 ± 4.18
    Notes
    [46] - n=3, except at 4 hours after end of infusion where n=2
    [47] - n=3, except at 1, 2, 4, and 8 hours after end of infusion where n=2
    [48] - n=3, except at 1 and 4 hours after end of infusion where n=2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events were collected from baseline through Day 30.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    GWP42003-P 0.1 mg/kg
    Reporting group description
    		 Patients with neonatal hypoxic-ischemic encephalopathy (NHIE) who received whole-body hypothermia as standard of care were randomized to receive a single intravenous (IV) dose of GWP42003-P 0.1 mg/kg.

    Reporting group title
    GWP42003-P 0.3 mg/kg
    Reporting group description
    		 Patients with neonatal hypoxic-ischemic encephalopathy (NHIE) who received whole-body hypothermia as standard of care were randomized to receive a single intravenous (IV) dose of GWP42003-P 0.3 mg/kg.

    Reporting group title
    GWP42003-P 1.0 mg/kg
    Reporting group description
    		 Patients with neonatal hypoxic-ischemic encephalopathy (NHIE) who received whole-body hypothermia as standard of care were randomized to receive a single intravenous (IV) dose of GWP42003-P 1.0 mg/kg.

    Reporting group title
    Pooled Placebo
    Reporting group description
    		 All patients with neonatal hypoxic-ischemic encephalopathy (NHIE) who received whole-body hypothermia as standard of care were randomized to receive a single intravenous (IV) dose of placebo-matched treatment.

    Serious adverse events
    		 GWP42003-P 0.1 mg/kg GWP42003-P 0.3 mg/kg GWP42003-P 1.0 mg/kg Pooled Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Nervous system disorders
    Brain stem infarction
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GWP42003-P 0.1 mg/kg GWP42003-P 0.3 mg/kg GWP42003-P 1.0 mg/kg Pooled Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    4 / 4 (100.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    0
    General disorders and administration site conditions
    Hyperthermia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Medical device site reaction
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    2
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Apnoea
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Atelectasis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Pulmonary haemorrhage
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    0
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    1
    Coagulation test abnormal
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Respiratory rate increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Brain stem infarction
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Grimacing
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Neonatal oversedation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Seizure
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tremor
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Coagulopathy
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Eye disorders
    Eyelid oedema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    0
    0
    2
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Renal and urinary disorders
    Oliguria
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sepsis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Feeding intolerance
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Hypocalcaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0

    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.
    This trial ended prematurely. Based on the collective data from the first 3 cohorts, the Data Safety Monitoring Committee determined the 3 mg/kg dose for Cohort 4 would not be required.
    For support, Contact us.
    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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