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    Clinical Trial Results:
    A Phase IIa: single ascending dose safety, tolerability and pharmacokinetic study of NicaPlant® in aneurysmal subarachnoid haemorrhage patients undergoing aneurysm clipping

    Summary
    EudraCT number
    		 2016-004521-17
    Trial protocol
    		 AT  
    Global end of trial date
    09 Jan 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Mar 2020
    First version publication date
    01 Mar 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BIT-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BIT Pharma GmbH
    Sponsor organisation address
    Leonhardstrasse 109, Graz, Austria, 8010
    Public contact
    Dr. Tiziana Adage, BIT Pharma GmbH, tiziana.adage@bit-pharma.com
    Scientific contact
    Dr. Tiziana Adage, BIT Pharma GmbH, tiziana.adage@bit-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
    01 Apr 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jan 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jan 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the safety and tolerability of single ascending doses (as number of implants/patient) of local nicardipine application via polymers (NicaPlant®).
    Protection of trial subjects
    A Data Safety Monitoring Board (DSMB) was set-up to monitor safety throughout the trial period. The DSMB performed dose escalation reviews between cohorts and prepared written reports advising the steering committee to progress to the next higher dose, to implement modifications or to terminate the study. The DSMB also performed interim meetings in case of the occurance of a SUSAR during the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 The comparator used in the clinical trial was nimodipine, of which 60 mg were administered every 4 hours. This treatment is the standard of care for patients suffering from an aneurysmal subarachnoid haemorrhage for prevention of ischemic neurological deficit following cerebral vasospasm.
    Actual start date of recruitment
    25 Apr 2018
    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
    Austria: 11
    Country: Number of subjects enrolled
    Germany: 3
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    12
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period of cohort 1: 12APR2018 - 28APR2018 (Austria) Recruitment period of cohort 2: 25MAY2018 - 27JUN2018 (Austria) Recruitment period of cohort 3: 19JUL2018 - 24SEP2018 (Austria and Germany) Recruitment period of cohort 4: 22OCT2018 - 20DEC2018 (Austria and Germany)

    Pre-assignment
    Screening details
    		 The screening period was between 0 and 48 hours after aneurysm rupture.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Subject, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control
    Arm description
    		 Control patients received 60 mg of orally administered nimodipine every 4 hours for 21 days. They did not receive the NicaPlant® implants.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Nimodipine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    60 mg every 4 hours for 21 days

    Arm title
    		 3 Implants
    Arm description
    		 3 Implants patients received 3 NicaPlant® implants at aneurysm clipping. They also received 60 mg of placebo-nimodipine every 4 hours for 21 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    NicaPlant®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Implantation
    Dosage and administration details
    3 NicaPlant® implants with 4 mg nicardipine load each. NicaPlant® is a biodegradable, rod shaped modified release formulation in implant form.

    Investigational medicinal product name
    Placebo-Nimodipine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    60 mg every 4 hours for 21 days

    Arm title
    		 6 Implants
    Arm description
    		 6 Implants patients received 6 NicaPlant® implants at aneurysm clipping. They also received 60 mg of placebo-nimodipine every 4 hours for 21 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    NicaPlant®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Implantation
    Dosage and administration details
    6 NicaPlant® implants with 4 mg nicardipine load each. NicaPlant® is a biodegradable, rod shaped modified release formulation in implant form.

    Investigational medicinal product name
    Placebo-Nimodipine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    60 mg every 4 hours for 21 days

    Arm title
    		 10 Implants
    Arm description
    		 10 Implants patients received 10 NicaPlant® implants at aneurysm clipping. They also received 60 mg of placebo-nimodipine every 4 hours for 21 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    NicaPlant®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Implantation
    Dosage and administration details
    10 NicaPlant® implants with 4 mg nicardipine load each. NicaPlant® is a biodegradable, rod shaped modified release formulation in implant form.

    Investigational medicinal product name
    Placebo-Nimodipine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    60 mg every 4 hours for 21 days

    Arm title
    		 13 Implants
    Arm description
    		 13 Implants patients received 13 NicaPlant® implants at aneurysm clipping. They also received 60 mg of placebo-nimodipine every 4 hours for 21 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    NicaPlant®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Implantation
    Dosage and administration details
    13 NicaPlant® implants with 4 mg nicardipine load each. NicaPlant® is a biodegradable, rod shaped modified release formulation in implant form.

    Investigational medicinal product name
    Placebo-Nimodipine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    60 mg every 4 hours for 21 days

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: No placebo implants were implanted due to ethical reasons. It was for this reason not possible to blind the surgeon/investigator of the trial. The trial was conducted as a single blinded trial, i.e. the subject was blinded. However, the trial was conducted maintaining the blinding as much as possible. Therefore, besides the subjects, also the monitor, data analyst, carers and assessor of DSA and CT were blinded.
    Number of subjects in period 1
    		Control 3 Implants 6 Implants 10 Implants 13 Implants
    Started
    4
    2
    2
    3
    3
    Completed
    4
    2
    2
    3
    3

    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
    		 14 14
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 12 12
        From 65-84 years
    		 2 2
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    Control
    Reporting group description
    		 Control patients received 60 mg of orally administered nimodipine every 4 hours for 21 days. They did not receive the NicaPlant® implants.

    Reporting group title
    3 Implants
    Reporting group description
    		 3 Implants patients received 3 NicaPlant® implants at aneurysm clipping. They also received 60 mg of placebo-nimodipine every 4 hours for 21 days.

    Reporting group title
    6 Implants
    Reporting group description
    		 6 Implants patients received 6 NicaPlant® implants at aneurysm clipping. They also received 60 mg of placebo-nimodipine every 4 hours for 21 days.

    Reporting group title
    10 Implants
    Reporting group description
    		 10 Implants patients received 10 NicaPlant® implants at aneurysm clipping. They also received 60 mg of placebo-nimodipine every 4 hours for 21 days.

    Reporting group title
    13 Implants
    Reporting group description
    		 13 Implants patients received 13 NicaPlant® implants at aneurysm clipping. They also received 60 mg of placebo-nimodipine every 4 hours for 21 days.

    Primary: Safety and tolerability of single ascending doses of NicaPlant® by drug related adverse event reporting

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    End point title
    		 Safety and tolerability of single ascending doses of NicaPlant® by drug related adverse event reporting [1]
    End point description
    End point type
    Primary
    End point timeframe
    continuouse over 21 days post-aneurysm rupture
    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: Due to the small number of patients in each treatment arm, the results were only descriptively summerized and no formal statistical analysis was done.
    End point values
    		 Control 3 Implants 6 Implants 10 Implants 13 Implants
    Number of subjects analysed
    4
    2
    2
    3
    3
    Units: drug related adverse events
        Drug related adverse events
    2
    0
    0
    1
    1
        Drug related serious adverse events
    0
    0
    0
    3
    2
    No statistical analyses for this end point

    Secondary: Pharmacokinetic parameter nicardipine in plasma

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    End point title
    		 Pharmacokinetic parameter nicardipine in plasma [2]
    End point description
    End point type
    Secondary
    End point timeframe
    21 days post implantation of NicaPlant®
    Notes
    [2] - 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: Pharmacokinetic samples were only analysed in the treatment arms. The control arm did not receive NicaPlant® of which the pharmacokinetic profile was analysed.
    End point values
    		 3 Implants 6 Implants 10 Implants 13 Implants
    Number of subjects analysed
    0 [3]
    0 [4]
    3
    3
    Units: Cmax (ng/mL)
        arithmetic mean (standard deviation)
    ( )
    ( )
    1.903 ( 0.51 )
    2.366 ( 1.372 )
    Attachments
    		 Plasma Nicardipine
    Plasma Nicardipine
    Notes
    [3] - Subject number too small.
    [4] - Subject number too small.
    No statistical analyses for this end point

    Secondary: Pharmacokinetic parameter nicardipine in cerebrospinal fluid

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    End point title
    		 Pharmacokinetic parameter nicardipine in cerebrospinal fluid [5]
    End point description
    Cmax of the individual participant of the arm with the highest Cmax
    End point type
    Secondary
    End point timeframe
    21 days post implantation of NicaPlant®
    Notes
    [5] - 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: Pharmacokinetic samples were only analysed in the treatment arms. The control arm did not receive NicaPlant® of which the pharmacokinetic profile was analysed.
    End point values
    		 3 Implants 6 Implants 10 Implants 13 Implants
    Number of subjects analysed
    1 [6]
    1 [7]
    1 [8]
    0 [9]
    Units: Cmax (ng/ml)
        number (not applicable)
    23.5
    207
    147
    Attachments
    		 CSF Nicardipine
    Notes
    [6] - Tmax = day 10 The concentration of the second participant in the arm was below the detection limit.
    [7] - Tmax = day 14 The Cmax of the second participant of the arm was 117 ng/mL (Tmax = day 6).
    [8] - Tmax = day 0 Only one participant in the arm had an EVD.
    [9] - 1 patient with samples. Values below det. limit probably due to loss of drug in op 1 day after admin
    No statistical analyses for this end point

    Other pre-specified: Incidence of moderate or severe cerebral angiographic vasospasm at 8±1 days after aneurysm rupture

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    End point title
    		 Incidence of moderate or severe cerebral angiographic vasospasm at 8±1 days after aneurysm rupture
    End point description
    Incidence of moderate or severe cerebral angiographic vasospasm assessed by digital subtraction angiography (DSA) or CT angiography (CTA) at 8±1 days after aneurysm rupture, at the discretion of the physician and according to the institutional protocol. DSA or CTA were only performed if medically indicated, where angiographic vasospasm was defined as a ≥33% reduction in diameter in at least one vessel segment by comparison to preoperative (pre NicaPlant® implantation) angiography. If the patient develops clinical or sonographic changes suggestive of vasospasm prior to day 8, an angiogram was performed to confirm the vasospasm and the angiographic measurement replaced the one scheduled at day 8±1.
    End point type
    Other pre-specified
    End point timeframe
    8±1 days after aneurysm rupture or earlier if the patient develops clinical or sonographic changes suggestive of vasospasm.
    End point values
    		 Control 3 Implants 6 Implants 10 Implants 13 Implants
    Number of subjects analysed
    4
    1 [10]
    2
    3
    3
    Units: moderate or severe vasospasm
        ≥33% to ≤66% lumen reduction
    0
    0
    0
    0
    1
        >66% lumen reduction
    2
    1
    0
    0
    0
    Notes
    [10] - One patient was not assessable because only a DSA of the left carotis interna (LCI) was available.
    No statistical analyses for this end point

    Other pre-specified: Incidence of vasospasm-related morbidity/mortality within 21 days post-aneurysm rupture

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    End point title
    		 Incidence of vasospasm-related morbidity/mortality within 21 days post-aneurysm rupture
    End point description
    End point type
    Other pre-specified
    End point timeframe
    within 21 days post-aneurysm rupture
    End point values
    		 Control 3 Implants 6 Implants 10 Implants 13 Implants
    Number of subjects analysed
    4
    2
    2
    3
    3
    Units: Vasospasm-related morbidity/mortality
        morbidity
    0
    1
    0
    1
    1
        mortality
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Need for anti-vasospasm rescue therapy within 21 days post-aneurysm rupture

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    End point title
    		 Need for anti-vasospasm rescue therapy within 21 days post-aneurysm rupture
    End point description
    End point type
    Other pre-specified
    End point timeframe
    within 21 days post-aneurysm rupture
    End point values
    		 Control 3 Implants 6 Implants 10 Implants 13 Implants
    Number of subjects analysed
    4
    2
    2
    3
    3
    Units: anti-vasospasm therapy
    2
    1
    0
    1
    1
    No statistical analyses for this end point

    Other pre-specified: Incidence of new cerebral infarcts at day 14±1 post-aneurysm rupture

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    End point title
    		 Incidence of new cerebral infarcts at day 14±1 post-aneurysm rupture
    End point description
    Incidence of new cerebral infarcts on CT scan performed at day 14±1 post-aneurysm rupture versus post-treatment (i.e. post clip ligation and NicaPlant Implantation) CT scan.
    End point type
    Other pre-specified
    End point timeframe
    at day 14±1 post-aneurysm rupture
    End point values
    		 Control 3 Implants 6 Implants 10 Implants 13 Implants
    Number of subjects analysed
    4
    2
    2
    3
    3
    Units: New cerebral infarcts
    1
    0
    1
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    25APR2018 - 08FEB2019
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Control
    Reporting group description
    		 Control patients received 60 mg of orally administered nimodipine every 4 hours for 21 days. They did not receive the NicaPlant implants.

    Reporting group title
    3 Implants
    Reporting group description
    		 3 Implants patients received 3 NicaPlant implants at clipping. They also received 60 mg of placebo-nimodipine every 4 hours for 21 days.

    Reporting group title
    6 Implants
    Reporting group description
    		 6 Implants patients received 6 NicaPlant implants at clipping. They also received 60 mg of placebo-nimodipine every 4 hours for 21 days.

    Reporting group title
    10 Implants
    Reporting group description
    		 10 Implants patients received 10 NicaPlant implants at clipping. They also received 60 mg of placebo-nimodipine every 4 hours for 21 days.

    Reporting group title
    13 Implants
    Reporting group description
    		 13 Implants patients received 13 NicaPlant implants at clipping. They also received 60 mg of placebo-nimodipine every 4 hours for 21 days.

    Serious adverse events
    		 Control 3 Implants 6 Implants 10 Implants 13 Implants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    2 / 3 (66.67%)
    1 / 3 (33.33%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Investigations
    CSF culture positive
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Cerebral artery occlusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral vasoconstriction
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haematoma
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracranial pressure increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory distress
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    2 / 3 (66.67%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Control 3 Implants 6 Implants 10 Implants 13 Implants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    2 / 2 (100.00%)
    2 / 2 (100.00%)
    2 / 3 (66.67%)
    3 / 3 (100.00%)
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    1
    0
    0
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Postoperative wound complication
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Surgical and medical procedures
    Gastrostomy
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    1
    1
    0
    0
    1
    Tracheostomy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Ventricular drainage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Diplopia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    Hydrocephalus
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Intracranial pressure increased
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    Cerebral vasoconstriction
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    1
    1
    1
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Thrombocytosis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    1
    1
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Hiccups
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Upper respiratory fungal infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    2 / 3 (66.67%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    Fungal infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Vaginal infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    CNS ventriculitis
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 2 (100.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Product issues
    Device failure
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    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.
    Due to the small number of patients in each treatment arm, the results were only descriptively summerized and no formal statistical analysis was done. CSF analysis was further limited because CSF samples were only taken of patients who had an EVD.
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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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