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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44207   clinical trials with a EudraCT protocol, of which   7332   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:
    BOTOX® for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients With Multiple Sclerosis

    Summary
    EudraCT number
    2012-000957-30
    Trial protocol
    BE   CZ   PT   GB  
    Global end of trial date
    27 Mar 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    27 Apr 2016
    First version publication date
    27 Apr 2016
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    191622-117
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01600716
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Allergan Limited
    Sponsor organisation address
    Allergan Limited Marlow International The Parkway, Marlow, Buckinghamshire, United Kingdom, SL7 1YL
    Public contact
    Allergan Limited EU Regulatory Dept, Allergan Limited, 44 1628 494444, ml-eu_reg_affairs@allergan.com
    Scientific contact
    Therapeutic Area Head,, Allergan Limited, 44 1628 494444, ml-eu_reg_affairs@allergan.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
    27 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Mar 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to evaluate the safety and efficacy of 100 U BOTOX compared to placebo injected into the detrusor for the treatment of urinary incontinence due to Neurogenic Detrusor Overactivity (NDO) resulting from Multiple Sclerosis (MS), in patients who are not catheterizing at baseline, and whose symptoms have not been adequately managed with anticholinergic therapy.
    Protection of trial subjects
    Patients were required to read and sign an Informed Consent Form prior to any study procedures.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 Jul 2012
    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
    United States: 80
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Canada: 21
    Country: Number of subjects enrolled
    Czech Republic: 15
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Poland: 19
    Country: Number of subjects enrolled
    Portugal: 1
    Worldwide total number of subjects
    144
    EEA total number of subjects
    43
    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)
    133
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Patients were screened up to 28 days prior to randomization on Day 1.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    OnabotulinumtoxinA
    Arm description
    OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
    Arm type
    Experimental

    Investigational medicinal product name
    OnabotulinumtoxinA
    Investigational medicinal product code
    Other name
    BOTOX
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.

    Arm title
    Placebo (Normal Saline)
    Arm description
    Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo (Normal Saline)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.

    Number of subjects in period 1
    OnabotulinumtoxinA Placebo (Normal Saline)
    Started
    66
    78
    Completed
    59
    71
    Not completed
    7
    7
         Adverse event, non-fatal
    1
    1
         Other Reasons
    3
    1
         Pregnancy
    1
    -
         Personal Reasons
    -
    2
         Lost to follow-up
    -
    2
         Lack of efficacy
    2
    1

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    OnabotulinumtoxinA
    Reporting group description
    OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.

    Reporting group title
    Placebo (Normal Saline)
    Reporting group description
    Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.

    Reporting group values
    OnabotulinumtoxinA Placebo (Normal Saline) Total
    Number of subjects
    66 78 144
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    62 71 133
        From 65-84 years
    4 7 11
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    51.5 ( 10.36 ) 51.7 ( 10.28 ) -
    Gender, Male/Female
    Units: Participants
        Female
    57 70 127
        Male
    9 8 17

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    OnabotulinumtoxinA
    Reporting group description
    OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.

    Reporting group title
    Placebo (Normal Saline)
    Reporting group description
    Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.

    Primary: Change from Baseline in Daily Average Frequency of Urinary Incontinence Episodes

    Close Top of page
    End point title
    Change from Baseline in Daily Average Frequency of Urinary Incontinence Episodes [1]
    End point description
    Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. The number of episodes of urinary incontinence is recorded over a 3-day period the week of the study visit. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change indicates an increase in incontinence episodes (worsening).
    End point type
    Primary
    End point timeframe
    Baseline, Week 6
    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 is reported for this outcome measure
    End point values
    OnabotulinumtoxinA Placebo (Normal Saline)
    Number of subjects analysed
    66
    78
    Units: Episodes
    arithmetic mean (standard deviation)
        Baseline
    4.18 ( 3.167 )
    4.32 ( 2.422 )
        Change from Baseline at Week 6
    -3.34 ( 2.881 )
    -1.1 ( 2.083 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Maximum Cystometric Capacity (MCC)

    Close Top of page
    End point title
    Change from Baseline in Maximum Cystometric Capacity (MCC)
    End point description
    MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in the maximum volume of urine the bladder holds and a negative number change from baseline represents a worsening (decrease) in the maximum volume of urine the bladder holds.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6
    End point values
    OnabotulinumtoxinA Placebo (Normal Saline)
    Number of subjects analysed
    65
    78
    Units: Milliliters (mL)
    arithmetic mean (standard deviation)
        Baseline
    246.4 ( 138.49 )
    245.7 ( 133.9 )
        Change from Baseline at Week 6 (N=62,72)
    127.2 ( 139.25 )
    -1.8 ( 93.23 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC)

    Close Top of page
    End point title
    Change from Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC)
    End point description
    Maximum detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. A negative number change from baseline indicates an improvement in pressure and a positive number change from baseline indicates a worsening in pressure.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6
    End point values
    OnabotulinumtoxinA Placebo (Normal Saline)
    Number of subjects analysed
    57
    69
    Units: Centimeters of Water (cm H2O)
    arithmetic mean (standard deviation)
        Baseline
    35.9 ( 34.9 )
    36.1 ( 37.21 )
        Change from Baseline at Week 6 (N=25,51)
    -19.6 ( 37.61 )
    3.7 ( 33.24 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

    Close Top of page
    End point title
    Change from Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
    End point description
    The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement and a negative change from baseline represents a worsening.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6
    End point values
    OnabotulinumtoxinA Placebo (Normal Saline)
    Number of subjects analysed
    58
    74
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Baseline
    32.43 ( 16.337 )
    34.24 ( 21.163 )
        Change from Baseline at Week 6 (N=55,68)
    40.39 ( 26.499 )
    9.92 ( 15.863 )
    No statistical analyses for this end point

    Other pre-specified: Duration of Treatment Effect

    Close Top of page
    End point title
    Duration of Treatment Effect
    End point description
    The duration of treatment effect is the time to patient request for retreatment.
    End point type
    Other pre-specified
    End point timeframe
    Up to 52 Weeks
    End point values
    OnabotulinumtoxinA Placebo (Normal Saline)
    Number of subjects analysed
    66 [2]
    78
    Units: Weeks
        median (confidence interval 95%)
    51.7 (36.9 to 9999)
    12.6 (12.3 to 13)
    Notes
    [2] - The upper CI limit is not estimable; too few pts requested retreatment prior to study end (9999=NA)
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded from signing the informed consent to the end of study.
    Adverse event reporting additional description
    Adverse events and serious adverse events are analyzed by treatment cycle (cycle 1 and cycle 2).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    OnabotulinumtoxinA Treatment Cycle 1
    Reporting group description
    OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. Median duration of exposure is 50.7 weeks.

    Reporting group title
    Placebo (Normal Saline)/OnabotulinumtoxinA
    Reporting group description
    Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, an onabotulinumtoxinA injection is given. Median duration of exposure is 12.2 weeks.

    Reporting group title
    OnabotulinumtoxinA/OnabotulinumtoxinA Treatment Cycle 2
    Reporting group description
    OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, a second onabotulinumtoxinA injection is given. Median duration of exposure is 12.5 weeks.

    Reporting group title
    Placebo (Normal Saline)
    Reporting group description
    Placebo (normal saline) is administered into the detrusor at Day 1. Median duration of exposure is 15.2 weeks.

    Serious adverse events
    OnabotulinumtoxinA Treatment Cycle 1 Placebo (Normal Saline)/OnabotulinumtoxinA OnabotulinumtoxinA/OnabotulinumtoxinA Treatment Cycle 2 Placebo (Normal Saline)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 66 (10.61%)
    2 / 67 (2.99%)
    0 / 30 (0.00%)
    3 / 78 (3.85%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Spinal Compression Fracture
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 30 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 66 (1.52%)
    1 / 67 (1.49%)
    0 / 30 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Coronary Syndrome
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 30 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Multiple Sclerosis Relapse
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 30 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple sclerosis
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 30 (0.00%)
    0 / 78 (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
    General disorders and administration site conditions
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 30 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Dysuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 30 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular Weakness
    Additional description: Onset date was 135 days after administration of onabotulinumtoxinA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 30 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Urinary Tract Infection
         subjects affected / exposed
    3 / 66 (4.55%)
    0 / 67 (0.00%)
    0 / 30 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infectious Colitis
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 30 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         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
    OnabotulinumtoxinA Treatment Cycle 1 Placebo (Normal Saline)/OnabotulinumtoxinA OnabotulinumtoxinA/OnabotulinumtoxinA Treatment Cycle 2 Placebo (Normal Saline)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 66 (75.76%)
    38 / 67 (56.72%)
    21 / 30 (70.00%)
    48 / 78 (61.54%)
    Investigations
    Residual Urine Volume
         subjects affected / exposed
    11 / 66 (16.67%)
    5 / 67 (7.46%)
    1 / 30 (3.33%)
    2 / 78 (2.56%)
         occurrences all number
    13
    5
    1
    2
    Nervous system disorders
    Multiple Sclerosis Relapse
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    2 / 30 (6.67%)
    1 / 78 (1.28%)
         occurrences all number
    0
    0
    2
    2
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    1 / 30 (3.33%)
    4 / 78 (5.13%)
         occurrences all number
    1
    0
    1
    5
    Renal and urinary disorders
    Urinary Retention
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 66 (16.67%)
    9 / 67 (13.43%)
    6 / 30 (20.00%)
    3 / 78 (3.85%)
         occurrences all number
    12
    9
    6
    3
    Dysuria
         subjects affected / exposed
    5 / 66 (7.58%)
    1 / 67 (1.49%)
    3 / 30 (10.00%)
    1 / 78 (1.28%)
         occurrences all number
    5
    1
    6
    1
    Leukocyturia
         subjects affected / exposed
    4 / 66 (6.06%)
    2 / 67 (2.99%)
    1 / 30 (3.33%)
    6 / 78 (7.69%)
         occurrences all number
    4
    4
    1
    6
    Haematuria
         subjects affected / exposed
    3 / 66 (4.55%)
    2 / 67 (2.99%)
    0 / 30 (0.00%)
    6 / 78 (7.69%)
         occurrences all number
    3
    2
    0
    6
    Renal Cyst
         subjects affected / exposed
    3 / 66 (4.55%)
    1 / 67 (1.49%)
    3 / 30 (10.00%)
    3 / 78 (3.85%)
         occurrences all number
    3
    1
    3
    4
    Micturition Urgency
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 67 (0.00%)
    2 / 30 (6.67%)
    0 / 78 (0.00%)
         occurrences all number
    2
    0
    3
    0
    Pollakiuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 66 (3.03%)
    0 / 67 (0.00%)
    2 / 30 (6.67%)
    0 / 78 (0.00%)
         occurrences all number
    2
    0
    3
    0
    Urine Abnormality
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    2 / 30 (6.67%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Urine Odour Abnormal
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    2 / 30 (6.67%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Psychiatric disorders
    Insomnia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    2 / 30 (6.67%)
    1 / 78 (1.28%)
         occurrences all number
    0
    0
    2
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    26 / 66 (39.39%)
    17 / 67 (25.37%)
    9 / 30 (30.00%)
    9 / 78 (11.54%)
         occurrences all number
    48
    21
    13
    13
    Bacteriuria
         subjects affected / exposed
    12 / 66 (18.18%)
    6 / 67 (8.96%)
    3 / 30 (10.00%)
    6 / 78 (7.69%)
         occurrences all number
    21
    7
    3
    9
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 66 (6.06%)
    0 / 67 (0.00%)
    0 / 30 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    4
    0
    0
    1

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Dec 2012
    1) Immunogenicity testing (for toxin binding and toxin neutralizing antibodies) was included; and 2) A primary analysis of the data when all patients had been enrolled into the main study and had completed at least 12 weeks post-randomization (or prematurely exited prior to week 12) was included.

    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA