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    Clinical Trial Results:
    Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study Comparing EG-1962 to Standard of Care Oral Nimodipine in Adults with Aneurysmal Subarachnoid Hemorrhage

    Summary
    EudraCT number
    		 2015-005033-53
    Trial protocol
    		 DE   CZ   FI   DK   AT  
    Global end of trial date
    22 Jul 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Dec 2018
    First version publication date
    06 Dec 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EG-01-1962-03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02790632
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Edge Therapeutics, Inc.
    Sponsor organisation address
    300 Connell Dr, Ste 4000, Berkeley Heights, United States, 07922-2817
    Public contact
    Clinical Trial Information, Edge Therapeutics, Inc., 1 9083445257, cdandrea@edgetherapeutics.com
    Scientific contact
    Clinical Trial Information, Edge Therapeutics, Inc., 1 9083445257, cdandrea@edgetherapeutics.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 Sep 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jul 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the efficacy of intraventricular EG-1962 to standard of care oral nimodipine in subjects with aneurysmal subarachnoid hemmorhage (aSAH)
    Protection of trial subjects
    Subjects were treated in Intensive Care Units
    Background therapy
    		 -
    Evidence for comparator
    		 Oral nimodpine is the standard of care treatment for subjects with aSAH.
    Actual start date of recruitment
    20 Jun 2016
    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
    United States: 164
    Country: Number of subjects enrolled
    Hong Kong: 4
    Country: Number of subjects enrolled
    Australia: 5
    Country: Number of subjects enrolled
    New Zealand: 8
    Country: Number of subjects enrolled
    Singapore: 2
    Country: Number of subjects enrolled
    Canada: 31
    Country: Number of subjects enrolled
    Israel: 14
    Country: Number of subjects enrolled
    Austria: 4
    Country: Number of subjects enrolled
    Czech Republic: 6
    Country: Number of subjects enrolled
    Finland: 3
    Country: Number of subjects enrolled
    Germany: 41
    Worldwide total number of subjects
    282
    EEA total number of subjects
    54
    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)
    215
    From 65 to 84 years
    67
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with aneurysmal subarchnoid hemmorhage were recruited at sites located in the United States, Canada, Germany, Austria, Finland, Israel, Singapore, Hong Kong, Australia and New Zealand participated in this study. The study was open for recruitment from June 2016 to March 2018.

    Pre-assignment
    Screening details
    		 318 subjects were consented. 289 subjects were randomized.

    Period 1
    Period 1 title
    Randomization Phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Subject, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EG-1962
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Intraventricular nimodipine
    Investigational medicinal product code
    EG-1962
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intraventricular use
    Dosage and administration details
    A one-time infusion of EG-1962 was administered intraventricularly following repair of a ruptured saccular aneurysm.

    Investigational medicinal product name
    Placebo Capsules or Tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intraventricular use
    Dosage and administration details
    Subjects received up to 21 days of oral IP per standard of care

    Arm title
    		 Oral Nimodipine
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Oral Nimodipine Capsules or Tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received oral nimodipine up to 21 days per standard of care.

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraventricular use
    Dosage and administration details
    Subjects received a one time intraventricular injection of normal saline.

    Number of subjects in period 1
    		EG-1962 Oral Nimodipine
    Started
    138
    144
    Treated
    138
    144
    Completed
    121
    128
    Not completed
    17
    16
         Adverse event, serious fatal
    10
    15
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    6
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    EG-1962
    Reporting group description
    		 -

    Reporting group title
    Oral Nimodipine
    Reporting group description
    		 -

    Reporting group values
    		 EG-1962 Oral Nimodipine Total
    Number of subjects
    		 138 144 282
    Age categorical
    Units: Subjects
        Adults
    		 138 144 282
    Age continuous
    Units: years
        median (full range (min-max))
    		 55.7 (22 to 75) 56.5 (30 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 95 42 137
        Male
    		 43 102 145
    WFNS for randomization
    WFNS entered into IRT for stratification purposes
    Units: Subjects
        WFNS 1
    		 0 0 0
        WFNS 2
    		 69 69 138
        WFNS 3/4
    		 69 75 144

    End points

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    End points reporting groups
    Reporting group title
    EG-1962
    Reporting group description
    		 -

    Reporting group title
    Oral Nimodipine
    Reporting group description
    		 -

    Subject analysis set title
    GOSE Analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Favorable score is 6, 7 or 8.

    Primary: GOSE

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    End point title
    		 GOSE
    End point description
    Glasgow Coma Scale - Extended
    End point type
    Primary
    End point timeframe
    Day 90
    End point values
    		 EG-1962 Oral Nimodipine
    Number of subjects analysed
    135
    140
    Units: Number of subjects
    number (not applicable)
        1 - Death
    10
    15
        2 - Vegetative State
    2
    6
        3 - Lower Significant Disability
    28
    34
        4 - Upper Significant Disability
    21
    16
        5 - Lower Moderate Disability
    11
    11
        6 - Upper Moderate Disability
    27
    20
        7 - Lower Good Recovery
    14
    11
        8 - Upper Good Recovery
    23
    31
        Missing
    2
    0
    Statistical analysis title
    		 Analysis of GOSE Outcome
    Comparison groups
    EG-1962 v Oral Nimodipine
    Number of subjects included in analysis
    275
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7381 [1]
    Method
    		 Regression, Logistic
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Notes
    [1] - 2-sided p-value

    Secondary: MoCA

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    End point title
    		 MoCA
    End point description
    Montreal Cognitive Assessment
    End point type
    Secondary
    End point timeframe
    Day 90
    End point values
    		 EG-1962 Oral Nimodipine
    Number of subjects analysed
    104
    111
    Units: Number of subjects
    number (not applicable)
        Favorable (>= 26)
    46
    51
        Unfavorable (<26)
    58
    60
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs occurring after randomization up to the subject's final visit were recorded
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    EG-1962
    Reporting group description
    		 -

    Reporting group title
    Oral Nimodipine
    Reporting group description
    		 -

    Serious adverse events
    		 EG-1962 Oral Nimodipine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    63 / 138 (45.65%)
    69 / 144 (47.92%)
         number of deaths (all causes)
    10
    15
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Cerebral Ischaemia
    Additional description: Delayed Cerebral Ischemia
         subjects affected / exposed
    14 / 138 (10.14%)
    18 / 144 (12.50%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 19
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Hydrocephalus
         subjects affected / exposed
    17 / 138 (12.32%)
    12 / 144 (8.33%)
         occurrences causally related to treatment / all
    0 / 18
    2 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral vasoconstriction
    Additional description: cerebral vasospasm
         subjects affected / exposed
    8 / 138 (5.80%)
    18 / 144 (12.50%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    9 / 138 (6.52%)
    11 / 144 (7.64%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 12
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 EG-1962 Oral Nimodipine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    136 / 138 (98.55%)
    140 / 144 (97.22%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    10 / 138 (7.25%)
    10 / 144 (6.94%)
         occurrences all number
    10
    11
    Hypotension
         subjects affected / exposed
    9 / 138 (6.52%)
    14 / 144 (9.72%)
         occurrences all number
    11
    17
    Nervous system disorders
    Cerebral vasoconstriction
    Additional description: cerebral vasospasm
         subjects affected / exposed
    45 / 138 (32.61%)
    51 / 144 (35.42%)
         occurrences all number
    46
    55
    Hydrocephalus
         subjects affected / exposed
    19 / 138 (13.77%)
    19 / 144 (13.19%)
         occurrences all number
    21
    20
    Cerebral ischaemia
    Additional description: Delayed Cerebral Ischaemia
         subjects affected / exposed
    21 / 138 (15.22%)
    23 / 144 (15.97%)
         occurrences all number
    28
    38
    Intracranial Pressure Increased
         subjects affected / exposed
    24 / 138 (17.39%)
    20 / 144 (13.89%)
         occurrences all number
    25
    21
    Headache
         subjects affected / exposed
    20 / 138 (14.49%)
    14 / 144 (9.72%)
         occurrences all number
    23
    15
    Cerebral Infarction
         subjects affected / exposed
    9 / 138 (6.52%)
    9 / 144 (6.25%)
         occurrences all number
    11
    11
    Seizure
         subjects affected / exposed
    12 / 138 (8.70%)
    8 / 144 (5.56%)
         occurrences all number
    12
    8
    Cerebral Salt Wasting Syndrome
         subjects affected / exposed
    10 / 138 (7.25%)
    16 / 144 (11.11%)
         occurrences all number
    10
    16
    CNS Ventriculitis
         subjects affected / exposed
    8 / 138 (5.80%)
    4 / 144 (2.78%)
         occurrences all number
    8
    4
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    45 / 138 (32.61%)
    50 / 144 (34.72%)
         occurrences all number
    49
    56
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    8 / 138 (5.80%)
    14 / 144 (9.72%)
         occurrences all number
    8
    25
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    24 / 138 (17.39%)
    29 / 144 (20.14%)
         occurrences all number
    26
    30
    Nausea
         subjects affected / exposed
    10 / 138 (7.25%)
    11 / 144 (7.64%)
         occurrences all number
    11
    11
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    14 / 138 (10.14%)
    14 / 144 (9.72%)
         occurrences all number
    15
    14
    Agitation
         subjects affected / exposed
    13 / 138 (9.42%)
    11 / 144 (7.64%)
         occurrences all number
    13
    11
    Delirium
         subjects affected / exposed
    7 / 138 (5.07%)
    6 / 144 (4.17%)
         occurrences all number
    7
    6
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    9 / 138 (6.52%)
    10 / 144 (6.94%)
         occurrences all number
    9
    10
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    11 / 138 (7.97%)
    6 / 144 (4.17%)
         occurrences all number
    11
    6
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    37 / 138 (26.81%)
    34 / 144 (23.61%)
         occurrences all number
    42
    38
    Pneumonia
         subjects affected / exposed
    23 / 138 (16.67%)
    28 / 144 (19.44%)
         occurrences all number
    24
    29
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    24 / 138 (17.39%)
    27 / 144 (18.75%)
         occurrences all number
    24
    27
    Hypkalaemia
         subjects affected / exposed
    19 / 138 (13.77%)
    26 / 144 (18.06%)
         occurrences all number
    19
    29
    Hypomagnesaemia
         subjects affected / exposed
    9 / 138 (6.52%)
    8 / 144 (5.56%)
         occurrences all number
    9
    8

    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
    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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