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    Clinical Trial Results:
    A randomized, open-label, parallel group, multi-center, comparative, Phase IV trial of Levetiracetam (LEV) versus Topiramate (TPM) as adjunctive therapy to evaluate efficacy and safety in subjects with refractory partial onset seizures

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    2014-004402-15
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    12 May 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Feb 2016
    First version publication date
    05 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    N01353
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01229735
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Korea Co. Ltd.
    Sponsor organisation address
    5FL, Grace tower, 127, Teheran-ro, Gangnam-gu, Seoul, Korea, Republic of,
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 48 15 15, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 48 15 15, clinicaltrials@ucb.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
    10 Jun 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the long-term effects of levetiracetam (LEV) on retention rate in subjects with refractory partial onset seizure that are not fully controlled despite optimal treatment with 1 to 3 concomitant antiepileptic drugs (AEDs), compared to topiramate (TPM) as add-on therapy during the 52 week treatment period.
    Protection of trial subjects
    Not applicable
    Background therapy
    Not applicable
    Evidence for comparator
    In Korea, two of the most commonly prescribed new antiepileptic drugs (AEDs) as add-on therapy for patients with chronic refractory epilepsies are levetiracetam (LEV) and topiramate (TPM) although in a retrospective review, discontinuation of medication due to side effects occurred more often with TPM than LEV. To provide more useful evidence of LEV to clinicians, this study is aiming to compare long term retention rate of levetiracetam (LEV) to topiramate (TPM)
    Actual start date of recruitment
    17 Nov 2010
    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
    Korea, Republic of: 343
    Worldwide total number of subjects
    343
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    1
    Adults (18-64 years)
    330
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    447 subjects were screened, 343 subjects were randomized.

    Pre-assignment
    Screening details
    Participant Flow refers to the Randomized Set which consists of all subjects who were randomized in this study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Levetiracetam
    Arm description
    250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Levetiracetam
    Investigational medicinal product code
    LEV
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    250 mg and 500 mg levetiracetam tablets

    Arm title
    Topiramate
    Arm description
    25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
    Arm type
    Active comparator

    Investigational medicinal product name
    Topiramate
    Investigational medicinal product code
    TPM
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg and 100 mg topiramate tablets

    Number of subjects in period 1
    Levetiracetam Topiramate
    Started
    177
    166
    Completed
    111
    100
    Not completed
    66
    66
         SAE, non-fatal + AE, non-serious non-fatal
    1
    -
         Other Reason
    13
    10
         Protocol deviation
    13
    8
         Lack of efficacy
    8
    8
         SAE, non-fatal
    -
    4
         AE, non-serious non-fatal
    13
    17
         Consent withdrawn by subject
    18
    17
         Lost to follow-up
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Levetiracetam
    Reporting group description
    250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks

    Reporting group title
    Topiramate
    Reporting group description
    25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks

    Reporting group values
    Levetiracetam Topiramate Total
    Number of subjects
    177 166 343
    Age Categorical
    Units: Subjects
        <=18 years
    4 0 4
        Adults (18-64 years)
    165 162 327
        >=65 years
    8 4 12
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    40.9 ± 13.6 39.7 ± 11.8 -
    Gender Categorical
    Units: Subjects
        Male
    106 102 208
        Female
    71 64 135

    End points

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    End points reporting groups
    Reporting group title
    Levetiracetam
    Reporting group description
    250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks

    Reporting group title
    Topiramate
    Reporting group description
    25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks

    Subject analysis set title
    Levetiracetam (Full Analysis Set)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks

    Subject analysis set title
    Topiramate (Full Analysis Set)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks

    Subject analysis set title
    Levetiracetam (Per Protocol Set)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks

    Subject analysis set title
    Topiramate (Per Protocol Set)
    Subject analysis set type
    Per protocol
    Subject analysis set description
    25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks

    Primary: Percentage of subjects continuing the allocated investigational treatment from the first study treatment intake to Week 52, after the beginning of investigational treatment with levetiracetam compared to topiramate

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    End point title
    Percentage of subjects continuing the allocated investigational treatment from the first study treatment intake to Week 52, after the beginning of investigational treatment with levetiracetam compared to topiramate
    End point description
    End point type
    Primary
    End point timeframe
    From Baseline to Week 52
    End point values
    Levetiracetam (Full Analysis Set) Topiramate (Full Analysis Set)
    Number of subjects analysed
    176
    166
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    59.1
    56.6
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Levetiracetam (Full Analysis Set) v Topiramate (Full Analysis Set)
    Number of subjects included in analysis
    342
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.7007 [2]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.7
         upper limit
    1.7
    Notes
    [1] - The Odds Ratio (OR) for LEV vs TPM is based on logistic regression modeling of subject retention by treatment and center pooling category. A profile likelihood confidence interval for the OR is presented.
    [2] - P-value is from likelihood ratio test of treatment group regression coefficient against 0.

    Secondary: Number of subjects with at least one adverse event reported during the trial period from Baseline to Week 52

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    End point title
    Number of subjects with at least one adverse event reported during the trial period from Baseline to Week 52
    End point description
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 52
    End point values
    Levetiracetam Topiramate
    Number of subjects analysed
    177
    166
    Units: Participants
        Participants
    125
    128
    No statistical analyses for this end point

    Secondary: Time from the first study treatment intake to drug discontinuation due to adverse event (AE)

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    End point title
    Time from the first study treatment intake to drug discontinuation due to adverse event (AE)
    End point description
    For time to Study Drug Discontinuation due to AE, Kaplan-Meier estimation of event-free subjects does not fall to or below 75%, therefore no first quartile, median or third quartile of the time to event could be estimated in either group. -99/-999/-9999 = not estimable.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 52
    End point values
    Levetiracetam Topiramate
    Number of subjects analysed
    177
    166
    Units: month
    median (inter-quartile range (Q1-Q3))
        median (inter-quartile range)
    -999 (-9999 to -99)
    -999 (-9999 to -99)
    No statistical analyses for this end point

    Secondary: Median percent reduction in the weekly partial onset seizure (POS) frequency from Baseline during the total treatment Period from Baseline to Week 52

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    End point title
    Median percent reduction in the weekly partial onset seizure (POS) frequency from Baseline during the total treatment Period from Baseline to Week 52
    End point description
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 52
    End point values
    Levetiracetam (Full Analysis Set) Topiramate (Full Analysis Set)
    Number of subjects analysed
    174
    165
    Units: percent reduction
    median (inter-quartile range (Q1-Q3))
        median (inter-quartile range)
    74.47 (38 to 96.28)
    67.86 (29.21 to 87.24)
    No statistical analyses for this end point

    Secondary: Responders defined as number of subjects with at least 50 % reduction in the weekly POS frequency from baseline during the total treatment period from Baseline to Week 52

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    End point title
    Responders defined as number of subjects with at least 50 % reduction in the weekly POS frequency from baseline during the total treatment period from Baseline to Week 52
    End point description
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 52
    End point values
    Levetiracetam (Full Analysis Set) Topiramate (Full Analysis Set)
    Number of subjects analysed
    174
    165
    Units: responders
        participants
    120
    107
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
    Adverse event reporting additional description
    The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Topiramate
    Reporting group description
    25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks

    Reporting group title
    Levetiracetam
    Reporting group description
    250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks

    Serious adverse events
    Topiramate Levetiracetam
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 166 (9.04%)
    10 / 177 (5.65%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Face injury
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Arteriovenous malformation
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial septal defect
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 166 (0.00%)
    2 / 177 (1.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyskinesia
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    5 / 166 (3.01%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stupor
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Photophobia
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Alcoholic pancreatitis
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus ureteric
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigger finger
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Chronic tonsillitis
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 177 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Topiramate Levetiracetam
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    91 / 166 (54.82%)
    86 / 177 (48.59%)
    Investigations
    Weight decreased
         subjects affected / exposed
    17 / 166 (10.24%)
    3 / 177 (1.69%)
         occurrences all number
    19
    3
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    20 / 166 (12.05%)
    36 / 177 (20.34%)
         occurrences all number
    21
    40
    Dizziness
         subjects affected / exposed
    24 / 166 (14.46%)
    30 / 177 (16.95%)
         occurrences all number
    29
    47
    Tremor
         subjects affected / exposed
    0 / 166 (0.00%)
    9 / 177 (5.08%)
         occurrences all number
    0
    9
    Headache
         subjects affected / exposed
    24 / 166 (14.46%)
    17 / 177 (9.60%)
         occurrences all number
    25
    24
    Paraesthesia
         subjects affected / exposed
    16 / 166 (9.64%)
    2 / 177 (1.13%)
         occurrences all number
    19
    2
    Memory impairment
         subjects affected / exposed
    9 / 166 (5.42%)
    1 / 177 (0.56%)
         occurrences all number
    9
    1
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    7 / 166 (4.22%)
    9 / 177 (5.08%)
         occurrences all number
    8
    10
    Nausea
         subjects affected / exposed
    10 / 166 (6.02%)
    9 / 177 (5.08%)
         occurrences all number
    10
    11
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    26 / 166 (15.66%)
    3 / 177 (1.69%)
         occurrences all number
    32
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    16 / 166 (9.64%)
    24 / 177 (13.56%)
         occurrences all number
    22
    32

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Sep 2010
    Protocol Amendment 1, dated 02 Sep 2010, created a data safety monitoring plan. The following specific change was provided: The investigator or his/her designee verified the source data after the first case and after every 10 cases to ensure the credibility and quality of the data. No subjects were enrolled prior to the inception of this amendment.
    04 Nov 2010
    Protocol Amendment 2, dated 24 Nov 2010, incorporated several suggestions made by the IRB. The following specific changes were provided: - The patient population, inclusion criteria, exclusion criteria, permitted concomitant treatments, and number of participating sites were clarified - The IWRS randomization process was described - The statistical analyses were edited and clarified - Additional information was provided to explain the calculation of sample size Sixteen subjects were enrolled prior to the inception of this amendment.

    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
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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