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    Clinical Trial Results:
    A Multicenter, Double-blind, Randomized, Placebo-controlled, 4-Armed Parallel Group Study to Evaluate the Efficacy of Zolmitriptan 0.5-, 2.5- and 5-mg Nasal Spray in the Treatment of Acute Migraine Headache in Adolescents

    Summary
    EudraCT number
    		 2010-019203-31
    Trial protocol
    		 SK   EE   LV   HU   PL   FI   DE   BG  
    Global end of trial date
    24 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2017
    First version publication date
    05 Aug 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D1220C00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01211145
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    One MedImmune Way, Gaithersburg, United States, 20878
    Public contact
    Heather Wray, Medical Science Director, AstraZeneca, 46 0 31 706 4082, heather.wray@astrazeneca.com
    Scientific contact
    Heather Wray, Medical Science Director, AstraZeneca, 46 0 31 706 4082, heather.wray@astrazeneca.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
    24 Apr 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of ZOMIG nasal spray 0.5, 2.5, and 5 mg with placebo in the acute treatment of migraine headache in adolescents (aged 12 to 17 years), as measured by the primary outcome variable of pain-free status at 2 hours post-treatment.
    Protection of trial subjects
    An Ethics Committee (EC)/Institutional Review Board (IRB) approved the final study protocol, including the final version of the informed consent form and assent form, and any other written information provided to the patients. Substantial changes to the study protocol were documented in study protocol amendments, which were also approved by each EC/IRB. The investigator ensured the distribution of these documents to the applicable EC/IRB and to the study site staff. This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) and applicable regulatory requirements and the AstraZeneca policy on Bioethics. The principal investigator (PI) at each center ensured that the patient and their parent/guardian/legal representative were given full and adequate oral and written information about the nature, purpose, possible risk, and benefit of the study. Patients were notified that they were free to discontinue from the study at any time. The patient's parent/guardian/legal representative's signed and dated informed consent, and the patient's signed and dated assent, were obtained before conducting any procedure specific for the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Oct 2010
    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: 363
    Country: Number of subjects enrolled
    Hungary: 219
    Country: Number of subjects enrolled
    Slovakia: 77
    Country: Number of subjects enrolled
    Poland: 45
    Country: Number of subjects enrolled
    Serbia: 36
    Country: Number of subjects enrolled
    Latvia: 20
    Country: Number of subjects enrolled
    Finland: 19
    Country: Number of subjects enrolled
    Argentina: 11
    Country: Number of subjects enrolled
    Estonia: 7
    Country: Number of subjects enrolled
    Bulgaria: 1
    Worldwide total number of subjects
    798
    EEA total number of subjects
    388
    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)
    798
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This multicenter study was conducted between 7 October 2010 and 31 October 2013.

    Pre-assignment
    Screening details
    		 The study had a 30 day run-in period and up to a 10-week double-blind treatment period. Patients were randomized to receive ZOMIG nasal spray 0.5, 2.5, 5.0 mg, or matching placebo spray to treat a migraine headache. 1653 patients were enrolled, 798 were randomized.

    Pre-assignment period milestones
    Number of subjects started
    		 1653 [1]
    Number of subjects completed
    		 798

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Physician decision: 13
    Reason: Number of subjects
    		 Pregnancy: 1
    Reason: Number of subjects
    		 Unknown: 109
    Reason: Number of subjects
    		 Exclusion Criteria: 107
    Reason: Number of subjects
    		 Inclusion Criteria: 300
    Reason: Number of subjects
    		 Placebo responder: 325
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: In the country by country count which I entered, I included patients who were randomized while the form apparently is trying to align it with the number enrolled. I feel the number randomized in each country is the more appropriate count since these are the patients who contributed to the corresponding analyses.
    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo to ZOMIG nasal spray
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    one spray

    Arm title
    		 ZOMIG 0.5 mg
    Arm description
    		 ZOMIG nasal spray
    Arm type
    		 Experimental

    Investigational medicinal product name
    zolmitriptan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    one spray

    Arm title
    		 ZOMIG 2.5 mg
    Arm description
    		 ZOMIG nasal spray
    Arm type
    		 Experimental

    Investigational medicinal product name
    zolmitriptan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    one spray

    Arm title
    		 ZOMIG 5 mg
    Arm description
    		 ZOMIG nasal spray
    Arm type
    		 Experimental

    Investigational medicinal product name
    zolmitriptan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    one spray

    Number of subjects in period 1
    		Placebo ZOMIG 0.5 mg ZOMIG 2.5 mg ZOMIG 5 mg
    Started
    296
    115
    99
    288
    Completed
    270
    98
    86
    268
    Not completed
    26
    17
    13
    20
         Eligibility criteria not fulfilled
    16
    12
    10
    15
         Patient decision
    2
    1
    -
    2
         Severe noncompliance to protocol
    1
    -
    -
    -
         Study-specific withdrawal criteria
    1
    -
    -
    -
         Lost to follow-up
    3
    2
    1
    2
         Reason not specified
    3
    2
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to ZOMIG nasal spray

    Reporting group title
    ZOMIG 0.5 mg
    Reporting group description
    		 ZOMIG nasal spray

    Reporting group title
    ZOMIG 2.5 mg
    Reporting group description
    		 ZOMIG nasal spray

    Reporting group title
    ZOMIG 5 mg
    Reporting group description
    		 ZOMIG nasal spray

    Reporting group values
    		 Placebo ZOMIG 0.5 mg ZOMIG 2.5 mg ZOMIG 5 mg Total
    Number of subjects
    		 296 115 99 288 798
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 296 115 99 288 798
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 14.3 ( 1.67 ) 14.5 ( 1.72 ) 14.6 ( 1.77 ) 14.5 ( 1.67 ) -
    Gender, Male/Female
    All randomized patients
    Units: Participants
        Female
    		 188 71 62 172 493
        Male
    		 108 44 37 116 305
    Race
    Race
    Units: Subjects
        White
    		 275 106 91 271 743
        Black or African-American
    		 14 8 7 15 44
        Asian
    		 2 0 0 0 2
        American Indian or Alaska Native
    		 1 0 0 0 1
        Other
    		 4 1 1 2 8
    Subject analysis sets

    Subject analysis set title
    All Patients Randomized
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All Patients Randomized

    Subject analysis sets values
    		 All Patients Randomized
    Number of subjects
    798
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    798
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    14.4 ( 1.69 )
    Gender, Male/Female
    All randomized patients
    Units: Participants
        Female
    493
        Male
    305
    Race
    Race
    Units: Subjects
        White
    743
        Black or African-American
    44
        Asian
    2
        American Indian or Alaska Native
    1
        Other
    8

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to ZOMIG nasal spray

    Reporting group title
    ZOMIG 0.5 mg
    Reporting group description
    		 ZOMIG nasal spray

    Reporting group title
    ZOMIG 2.5 mg
    Reporting group description
    		 ZOMIG nasal spray

    Reporting group title
    ZOMIG 5 mg
    Reporting group description
    		 ZOMIG nasal spray

    Subject analysis set title
    All Patients Randomized
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All Patients Randomized

    Primary: Pain-free status at 2 hours post-treatment

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    End point title
    		 Pain-free status at 2 hours post-treatment
    End point description
    End point type
    Primary
    End point timeframe
    2 hours post-treatment.
    End point values
    		 Placebo ZOMIG 0.5 mg ZOMIG 2.5 mg ZOMIG 5 mg
    Number of subjects analysed
    253
    91
    81
    229
    Units: Participants
        Yes
    42
    20
    20
    68
        No
    211
    71
    61
    161
    Statistical analysis title
    		 Odds ratio comparison
    Comparison groups
    Placebo v ZOMIG 0.5 mg
    Number of subjects included in analysis
    344
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.312 [1]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 2.5
    Notes
    [1] - Unadjusted
    Statistical analysis title
    		 Odds ratio comparison
    Comparison groups
    Placebo v ZOMIG 2.5 mg
    Number of subjects included in analysis
    334
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.071 [2]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 3.26
    Notes
    [2] - Unadjusted
    Statistical analysis title
    		 Odds ratio comparison
    Comparison groups
    Placebo v ZOMIG 5 mg
    Number of subjects included in analysis
    482
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [3]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.4
         upper limit
    		 3.39
    Notes
    [3] - Unadjusted

    Secondary: Pain-free status at 24 hours post-treatment

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    End point title
    		 Pain-free status at 24 hours post-treatment
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours post-treatment
    End point values
    		 Placebo ZOMIG 0.5 mg ZOMIG 2.5 mg ZOMIG 5 mg
    Number of subjects analysed
    251
    91
    80
    227
    Units: Participants
        Yes
    155
    59
    60
    155
        No
    96
    32
    20
    72
    Statistical analysis title
    		 Odds ratio comparison
    Comparison groups
    Placebo v ZOMIG 0.5 mg
    Number of subjects included in analysis
    342
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.575 [4]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.91
    Notes
    [4] - Unadjusted
    Statistical analysis title
    		 Odds ratio comparison
    Comparison groups
    Placebo v ZOMIG 2.5 mg
    Number of subjects included in analysis
    331
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.032 [5]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.06
         upper limit
    		 3.31
    Notes
    [5] - Unadjusted
    Statistical analysis title
    		 Odds ratio comparison
    Comparison groups
    Placebo v ZOMIG 5 mg
    Number of subjects included in analysis
    478
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.137 [6]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.95
    Notes
    [6] - Unadjusted

    Secondary: Headache response at 2 hours post-treatment

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    End point title
    		 Headache response at 2 hours post-treatment
    End point description
    Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.
    End point type
    Secondary
    End point timeframe
    2 hours post-treatment
    End point values
    		 Placebo ZOMIG 0.5 mg ZOMIG 2.5 mg ZOMIG 5 mg
    Number of subjects analysed
    253
    91
    81
    229
    Units: Participants
        Yes
    99
    40
    43
    116
        No
    154
    51
    38
    113
    Statistical analysis title
    		 Odds ratio comparison
    Comparison groups
    Placebo v ZOMIG 0.5 mg
    Number of subjects included in analysis
    344
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.458 [7]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.96
    Notes
    [7] - Unadjusted
    Statistical analysis title
    		 Odds ratio comparison
    Comparison groups
    Placebo v ZOMIG 2.5 mg
    Number of subjects included in analysis
    334
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.021 [8]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.09
         upper limit
    		 3.03
    Notes
    [8] - Unadjusted
    Statistical analysis title
    		 Odds ratio comparison
    Comparison groups
    Placebo v ZOMIG 5 mg
    Number of subjects included in analysis
    482
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.01 [9]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.12
         upper limit
    		 2.32
    Notes
    [9] - Unadjusted

    Secondary: Headache response at 24 hours post-treatment

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    End point title
    		 Headache response at 24 hours post-treatment
    End point description
    Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.
    End point type
    Secondary
    End point timeframe
    24 hours post-treatment
    End point values
    		 Placebo ZOMIG 0.5 mg ZOMIG 2.5 mg ZOMIG 5 mg
    Number of subjects analysed
    251
    91
    80
    227
    Units: Participants
        Yes
    170
    63
    61
    168
        No
    81
    28
    19
    59
    Statistical analysis title
    		 Odds ratio comparison
    Comparison groups
    Placebo v ZOMIG 0.5 mg
    Number of subjects included in analysis
    342
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.753 [10]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.84
    Notes
    [10] - Unadjusted
    Statistical analysis title
    		 Odds ratio comparison
    Comparison groups
    Placebo v ZOMIG 2.5 mg
    Number of subjects included in analysis
    331
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.145 [11]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 2.79
    Notes
    [11] - Unadjusted
    Statistical analysis title
    		 Odds ratio comparison
    Comparison groups
    Placebo v ZOMIG 5 mg
    Number of subjects included in analysis
    478
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.127 [12]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 2.04
    Notes
    [12] - Unadjusted

    Secondary: Sustained headache response at 2 hours

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    End point title
    		 Sustained headache response at 2 hours
    End point description
    Sustained headache response at 2 hours is a binary response variable derived from the headache intensities recorded in the patient diary. Sustained headache response is defined as a reduction in migraine headache pain intensity from severe or moderate to mild or none a 1 hr. which is then maintained (without a return to moderate or severe pain) at 2 hrs. with no use of rescue medication prior to the 2 hr. assessment.
    End point type
    Secondary
    End point timeframe
    Up to 2 hours post-treatment
    End point values
    		 Placebo ZOMIG 0.5 mg ZOMIG 2.5 mg ZOMIG 5 mg
    Number of subjects analysed
    251
    91
    81
    224
    Units: Participants
        Yes
    59
    27
    27
    66
        No
    192
    64
    54
    158
    Statistical analysis title
    		 Odds ratio comparison
    Comparison groups
    Placebo v ZOMIG 0.5 mg
    Number of subjects included in analysis
    342
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.274 [13]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 2.32
    Notes
    [13] - Unadjusted
    Statistical analysis title
    		 Odds ratio comparison
    Comparison groups
    Placebo v ZOMIG 5 mg
    Number of subjects included in analysis
    475
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.127 [14]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 2.08
    Notes
    [14] - Unadjusted
    Statistical analysis title
    		 Odds ratio comparison
    Comparison groups
    Placebo v ZOMIG 2.5 mg
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.067 [15]
    Method
    		 Regression, Logistic
    Parameter type
    		 Log odds ratio
    Point estimate
    1.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 2.91
    Notes
    [15] - Unadjusted

    Secondary: Use of rescue medication during the first 24 hours after treatment

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    End point title
    		 Use of rescue medication during the first 24 hours after treatment
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours post-treatment.
    End point values
    		 Placebo ZOMIG 0.5 mg ZOMIG 2.5 mg ZOMIG 5 mg
    Number of subjects analysed
    253
    91
    81
    231
    Units: Participants
        Yes
    80
    22
    18
    47
        No
    173
    69
    63
    184
    Statistical analysis title
    		 Odds ratio comparison
    Comparison groups
    Placebo v ZOMIG 0.5 mg
    Number of subjects included in analysis
    344
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.153 [16]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 1.16
    Notes
    [16] - Unadjusted
    Statistical analysis title
    		 Odds ratio comparison
    Comparison groups
    Placebo v ZOMIG 2.5 mg
    Number of subjects included in analysis
    334
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.087 [17]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 1.08
    Notes
    [17] - Unadjusted
    Statistical analysis title
    		 Odds ratio comparison
    Comparison groups
    Placebo v ZOMIG 5 mg
    Number of subjects included in analysis
    484
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.004 [18]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 0.83
    Notes
    [18] - Unadjusted

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During double-blind treatment
    Adverse event reporting additional description
    Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to ZOMIG nasal spray

    Reporting group title
    ZOMIG 0.5 mg
    Reporting group description
    		 ZOMIG nasal spray

    Reporting group title
    ZOMIG 2.5 mg
    Reporting group description
    		 ZOMIG nasal spray

    Reporting group title
    ZOMIG 5 mg
    Reporting group description
    		 ZOMIG nasal spray

    Serious adverse events
    		 Placebo ZOMIG 0.5 mg ZOMIG 2.5 mg ZOMIG 5 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    0 / 231 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Placebo ZOMIG 0.5 mg ZOMIG 2.5 mg ZOMIG 5 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 253 (9.88%)
    14 / 92 (15.22%)
    9 / 81 (11.11%)
    59 / 231 (25.54%)
    Injury, poisoning and procedural complications
    Administration related reaction
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 92 (1.09%)
    0 / 81 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Dysgeusia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    3 / 253 (1.19%)
    6 / 92 (6.52%)
    5 / 81 (6.17%)
    29 / 231 (12.55%)
         occurrences all number
    3
    6
    5
    29
    Dizziness
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    2 / 253 (0.79%)
    1 / 92 (1.09%)
    0 / 81 (0.00%)
    6 / 231 (2.60%)
         occurrences all number
    2
    1
    0
    6
    Paraesthesia
         subjects affected / exposed
    1 / 253 (0.40%)
    1 / 92 (1.09%)
    1 / 81 (1.23%)
    2 / 231 (0.87%)
         occurrences all number
    1
    1
    1
    2
    Hypoaesthesia
         subjects affected / exposed
    1 / 253 (0.40%)
    1 / 92 (1.09%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    1
    0
    1
    Somnolence
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    3 / 231 (1.30%)
         occurrences all number
    0
    0
    0
    3
    Bradykinesia
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Burning sensation
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Head discomfort
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    3 / 231 (1.30%)
         occurrences all number
    0
    0
    0
    3
    Asthenia
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    0
    1
    Chills
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 92 (1.09%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    1
    0
    1
    Facial pain
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Feeling cold
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Feeling hot
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 92 (1.09%)
    0 / 81 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 253 (0.40%)
    1 / 92 (1.09%)
    0 / 81 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Eye disorders
    Eye irritation
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Photopsia
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Vision blurred
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Nausea
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    3 / 253 (1.19%)
    0 / 92 (0.00%)
    1 / 81 (1.23%)
    5 / 231 (2.16%)
         occurrences all number
    3
    0
    1
    5
    Abdominal pain upper
         subjects affected / exposed
    3 / 253 (1.19%)
    0 / 92 (0.00%)
    1 / 81 (1.23%)
    1 / 231 (0.43%)
         occurrences all number
    3
    0
    1
    1
    Vomiting
         subjects affected / exposed
    3 / 253 (1.19%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Oral discomfort
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Oral pain
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Oral pruritus
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal discomfort
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    4 / 253 (1.58%)
    1 / 92 (1.09%)
    2 / 81 (2.47%)
    7 / 231 (3.03%)
         occurrences all number
    4
    1
    2
    7
    Oropharyngeal pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    4 / 253 (1.58%)
    1 / 92 (1.09%)
    0 / 81 (0.00%)
    7 / 231 (3.03%)
         occurrences all number
    4
    1
    0
    7
    Throat irritation
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    3 / 231 (1.30%)
         occurrences all number
    1
    0
    0
    3
    Pharyngeal oedema
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    1
    0
    0
    2
    Rhinalgia
         subjects affected / exposed
    2 / 253 (0.79%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    2
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    0
    1
    Sneezing
         subjects affected / exposed
    2 / 253 (0.79%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hiccups
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Throat tightness
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Psychiatric disorders
    Disorientation
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Joint stiffness
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Muscular weakness
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Pain in jaw
         subjects affected / exposed
    0 / 253 (0.00%)
    0 / 92 (0.00%)
    0 / 81 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 92 (1.09%)
    0 / 81 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Nov 2010
    1) Increased number of study sites and added Europe, deleted South Africa;
    10 Jan 2012
    2) Changed inclusion criteria; changed randomization from strictly sequential assignment to blocked randomization schedule
    06 Sep 2012
    3) Changed international coordinating investigator; changed details of interim analyses; changed inclusion criteria

    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 futility at the interim analysis, fewer subjects were randomized to the 0.5- and 2.5-mg groups. This precluded a full evaluation of these treatment arms at the end of the study.
    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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