Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35342   clinical trials with a EudraCT protocol, of which   5785   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Multi-center, Open-label, Non-controlled Study To Evaluate The Efficacy And Safety Of Lorazepam Intravenously Administered In Subjects With Status Epilepticus Or Repetitive Status Epilepticus

    Summary
    EudraCT number
    2017-000125-13
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    22 Aug 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Feb 2017
    First version publication date
    16 Feb 2017
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    B3541002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02239380
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer Inc., Pfizer ClinicalTrials.gov Call Center, 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Nov 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of lorazepam intravenously administered in subjects with Status Epilepticus (SE).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    25 Nov 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 26
    Worldwide total number of subjects
    26
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    4
    Children (2-11 years)
    10
    Adolescents (12-17 years)
    3
    Adults (18-64 years)
    9
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    This study was conducted from 25 November 2014 to 22 August 2016 in Japan.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Lorazepam
    Arm description
    Subjects aged between 3 months to below 16 years received single intravenous dose (Dose 1) of 0.05 milligram per kilogram (mg/kg) of Lorazepam (up to a maximum dose of 4 mg) on Day 1. Subjects aged above 16 years received single intravenous dose of 4 mg of lorazepam. Subjects whose seizures continued or recurred within 10 minutes following the initial dose, an additional dose (Dose 2) of 4 mg (for subjects above 16 years of age) or 0.05 mg/kg dose (subjects between 3 months to below 16 years of age) was administered accordingly. Subjects were followed up to 7 days after last dose of study drug administration.
    Arm type
    Experimental

    Investigational medicinal product name
    Lorazepam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects aged between 3 months to below 16 years received single dose of 0.05 mg/kg of Lorazepam on Day 1. Subjects aged above 16 years received single dose of 4 mg of Lorazepam on Day 1.

    Number of subjects in period 1
    Lorazepam
    Started
    26
    Completed
    26

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Lorazepam
    Reporting group description
    Subjects aged between 3 months to below 16 years received single intravenous dose (Dose 1) of 0.05 milligram per kilogram (mg/kg) of Lorazepam (up to a maximum dose of 4 mg) on Day 1. Subjects aged above 16 years received single intravenous dose of 4 mg of lorazepam. Subjects whose seizures continued or recurred within 10 minutes following the initial dose, an additional dose (Dose 2) of 4 mg (for subjects above 16 years of age) or 0.05 mg/kg dose (subjects between 3 months to below 16 years of age) was administered accordingly. Subjects were followed up to 7 days after last dose of study drug administration.

    Reporting group values
    Lorazepam Total
    Number of subjects
    26 26
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    4 4
        Children (2-11 years)
    10 10
        Adolescents (12-17 years)
    3 3
        Adults (18-64 years)
    9 9
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    14 ± 12.9 -
    Gender, Male/Female
    Units: Subjects
        Female
    10 10
        Male
    16 16

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Lorazepam
    Reporting group description
    Subjects aged between 3 months to below 16 years received single intravenous dose (Dose 1) of 0.05 milligram per kilogram (mg/kg) of Lorazepam (up to a maximum dose of 4 mg) on Day 1. Subjects aged above 16 years received single intravenous dose of 4 mg of lorazepam. Subjects whose seizures continued or recurred within 10 minutes following the initial dose, an additional dose (Dose 2) of 4 mg (for subjects above 16 years of age) or 0.05 mg/kg dose (subjects between 3 months to below 16 years of age) was administered accordingly. Subjects were followed up to 7 days after last dose of study drug administration.

    Primary: Percentage of Subjects Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug

    Close Top of page
    End point title
    Percentage of Subjects Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug [1]
    End point description
    Subjects with clinical benefit were defined as subjects whose initial seizure stopped within 10 minutes after initial dose (Dose 1) and who continued seizure-free for at least 30 minutes after the completion of initial dose (Dose 1). Full analysis set (FAS) included all subjects who received at least 1 dose of study drug, excluded those subjects whose status epilepticus (SE) or repetitive SE/cluster seizure was determined on the electroencephalography (EEG).
    End point type
    Primary
    End point timeframe
    30 minutes post Dose 1
    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 analysis was planned for this primary endpoing
    End point values
    Lorazepam
    Number of subjects analysed
    25
    Units: percentage of subjects
        number (confidence interval 95%)
    48 (27.8 to 68.7)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug

    Close Top of page
    End point title
    Percentage of Subjects Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug
    End point description
    Percentage of subjects whose initial seizure stopped within 10 minutes after the administration of study drug (either Dose 1 or 2 [in 10 to 30 minutes from the initial dose]) and who continued seizure-free for at least 30 minutes were analyzed and reported in this endpoint. FAS included all subjects who received at least 1 dose of study drug, excluded those subjects whose SE or repetitive SE/cluster seizure was determined on the EEG.
    End point type
    Secondary
    End point timeframe
    30 minutes post Dose 1 or 2
    End point values
    Lorazepam
    Number of subjects analysed
    25
    Units: percentage of subjects
        number (confidence interval 95%)
    64 (42.5 to 82)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Seizure Free Interval of At Least 12 Hours After Administration (Either Initial or Any Dose) of Study Drug

    Close Top of page
    End point title
    Percentage of Subjects Who Achieved Seizure Free Interval of At Least 12 Hours After Administration (Either Initial or Any Dose) of Study Drug
    End point description
    Percentage of subjects whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to be seizure-free for at least 12 hours post-dose were analyzed and reported in this endpoint. FAS included all subjects who received at least 1 dose of study drug, excluded those subjects whose SE or repetitive SE/cluster seizure was determined on the EEG.
    End point type
    Secondary
    End point timeframe
    12 hour post Dose 1; 12 hour post Dose 1 or 2
    End point values
    Lorazepam
    Number of subjects analysed
    25
    Units: percentage of subjects
    number (not applicable)
        Post Dose 1
    32
        Post Dose 1 or 2
    44
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Seizure Free Interval of At Least 24 Hours After Administration (Either Initial or Any Dose) of Study Drug

    Close Top of page
    End point title
    Percentage of Subjects Who Achieved Seizure Free Interval of At Least 24 Hours After Administration (Either Initial or Any Dose) of Study Drug
    End point description
    Percentage of subjects whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to be seizure-free for at least 24 hours post-dose were analyzed and reported in this endpoint. FAS included all subjects who received at least 1 dose of study drug, excluded those subjects whose SE or repetitive SE/cluster seizure was determined on the EEG.
    End point type
    Secondary
    End point timeframe
    24 hour post Dose 1; 24 hour post Dose 1 or 2
    End point values
    Lorazepam
    Number of subjects analysed
    25
    Units: percentage of subjects
    number (not applicable)
        Post Dose 1
    24
        Post Dose 1 or 2
    32
    No statistical analyses for this end point

    Secondary: Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug

    Close Top of page
    End point title
    Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug
    End point description
    Time to resolution (in minutes) was defined as the duration between the administration of study drug until the seizure resolved without receiving the prohibited medications. FAS included all subjects who received at least 1 dose of study drug, excluded those subjects whose SE or repetitive SE/cluster seizure was determined on the EEG. Here, 'n' signifies those subjects who were evaluable for specific category.
    End point type
    Secondary
    End point timeframe
    10 minutes post Dose 1; 10 minutes post Dose 1 or 2
    End point values
    Lorazepam
    Number of subjects analysed
    25
    Units: minutes
    median (full range (min-max))
        Post Dose 1 (n =15)
    1 (0 to 10)
        Post Dose 1 or 2 (n =17)
    1 (0 to 10)
    No statistical analyses for this end point

    Secondary: Time to Relapse Following The Administration (Either Initial or Any Dose) of Study Drug

    Close Top of page
    End point title
    Time to Relapse Following The Administration (Either Initial or Any Dose) of Study Drug
    End point description
    Time to relapse (in minutes) was defined duration from the time of study drug administration to the time of relapse, as determined by investigator. Subjects whose seizure stops within 10 minutes without receiving the prohibited medications were analyzed in this endpoint. FAS included all subjects who received at least 1 dose of study drug, excluded those subjects whose SE or repetitive SE/cluster seizure was determined on the EEG. Here, number of subjects analyzed (N) signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    24 hour post Dose 1; 24 hour post Dose 1 or 2
    End point values
    Lorazepam
    Number of subjects analysed
    9
    Units: minutes
    median (full range (min-max))
        Post Dose 1
    62 (11 to 879)
        Post Dose 1 or 2
    103 (23 to 1246)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Close Top of page
    End point title
    Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study (Day 12), that were absent before treatment or that worsened relative to pre-treatment state. AEs include both serious and non-serious adverse events. Safety analysis set included all participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline up to 7 days after last dose of study drug administration (up to 12 days)
    End point values
    Lorazepam
    Number of subjects analysed
    26
    Units: subjects
        AEs
    12
        SAEs
    1
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 7 days after last dose of study drug administration (up to 12 days)
    Adverse event reporting additional description
    The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one event and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Lorazepam
    Reporting group description
    Subjects aged between 3 months to below 16 years received single intravenous dose (Dose 1) of 0.05 milligram per kilogram (mg/kg) of Lorazepam (up to a maximum dose of 4 mg) on Day 1. Subjects aged above 16 years received single intravenous dose of 4 mg of lorazepam. Subjects whose seizures continued or recurred within 10 minutes following the initial dose, an additional dose (Dose 2) of 4 mg (for subjects above 16 years of age) or 0.05 mg/kg dose (subjects between 3 months to below 16 years of age) was administered accordingly. Subjects were followed up to 10 days after last dose of study drug administration.

    Serious adverse events
    Lorazepam
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 26 (3.85%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Lorazepam
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 26 (46.15%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences all number
    1
    Laceration
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences all number
    1
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences all number
    1
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences all number
    1
    Balance disorder
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences all number
    1
    Somnolence
         subjects affected / exposed
    2 / 26 (7.69%)
         occurrences all number
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences all number
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 26 (7.69%)
         occurrences all number
    2
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences all number
    1
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences all number
    1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences all number
    1

    More information

    Close Top of page

    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
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA