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    Clinical Trial Results:
    Four Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

    Due to a system error, the data reported in version v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2015-000606-20
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    26 Jul 2007

    Results information
    Results version number
    		 v2(current)
    This version publication date
    25 Mar 2016
    First version publication date
    19 Jun 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    deletion of extra milestone

    Trial information

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    Trial identification
    Sponsor protocol code
    A1281132
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00257166
    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 ClinicalTrials.gov Call Center, Pfizer, Inc., 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
    23 Jun 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jul 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To establish efficacy of oral ziprasidone (60-80 milligram [mg] twice a day [BID]) compared with placebo in the treatment of children and adolescents with Bipolar I Disorder - Single Manic Episode, Bipolar I Disorder – Most Recent Episode Manic; or Bipolar I Disorder – Most Recent Episode Mixed; as measured by the change from baseline to Week 4 in Young Mania Rating Scale (YMRS) total score. •To evaluate the safety and tolerability of oral ziprasidone (60-80 mg BID) over 4 weeks in the treatment of children and adolescents with Bipolar I Disorder (manic or mixed).
    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 Conference on 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
    13 Jan 2006
    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: 237
    Worldwide total number of subjects
    237
    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)
    50
    Adolescents (12-17 years)
    186
    Adults (18-64 years)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study was conducted at 36 sites in the United States. Study started on 13 January 2006 and completed on 26 July 2007. Total 238 subjects were randomized to treatment, of which 237 received treatment. One subject was randomized, but not treated. Study disposition is provided for the treated subjects.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ziprasidone
    Arm description
    		 Ziprasidone capsule administered orally in 2 divided doses with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation as per investigator’s discretion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ziprasidone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Ziprasidone capsule administered in 2 divided doses daily in the morning and evening with a starting dose of 20 mg/day as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of 120 to 160 mg/day for subjects with greater than or equal to (>=) 45 kilogram (kg) weight and 60 to 80 mg/day for subjects with less than (<) 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for subjects with >=45 kg weight and ziprasidone capsule 40 to 80 mg/day for subjects with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.

    Arm title
    		 Placebo
    Arm description
    		 Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to ziprasidone daily up to Week 4.

    Number of subjects in period 1
    		Ziprasidone Placebo
    Started
    149
    88
    Completed
    97
    51
    Not completed
    52
    37
         Consent withdrawn by subject
    9
    2
         Adverse Event
    18
    13
         Unspecified
    16
    21
         Laboratory abnormality
    1
    -
         Lost to follow-up
    8
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ziprasidone
    Reporting group description
    		 Ziprasidone capsule administered orally in 2 divided doses with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation as per investigator’s discretion.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matched to ziprasidone capsule orally twice daily up to Week 4.

    Reporting group values
    		 Ziprasidone Placebo Total
    Number of subjects
    		 149 88 237
    Age, Customized
    Units: subjects
        10 to 13 years
    		 74 35 109
        14 to 17 years
    		 74 53 127
        >=18 years
    		 1 0 1
    Gender, Male/Female
    Units: subjects
        Female
    		 65 41 106
        Male
    		 84 47 131

    End points

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    End points reporting groups
    Reporting group title
    Ziprasidone
    Reporting group description
    		 Ziprasidone capsule administered orally in 2 divided doses with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation as per investigator’s discretion.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matched to ziprasidone capsule orally twice daily up to Week 4.

    Primary: Change from Baseline in Young Mania Rating Scale (YMRS) Score at Week 4

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    End point title
    		 Change from Baseline in Young Mania Rating Scale (YMRS) Score at Week 4
    End point description
    YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania. Intent-to-treat (ITT): all randomized subjects who had baseline measurements, took at least (>=) 1 dose of study medication (ziprasidone or placebo) and had >=1 post-baseline visit. Here, ‘n’ signifies those subjects who were available for this measure at given time points for each group.
    End point type
    Primary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    143
    86
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n=143,86)
    26.2 ± 6.6
    27 ± 6.6
        Change at Week 4 (n=97,51)
    -13.8 ± 7.8
    -9.9 ± 7.7
    Statistical analysis title
    		 Change at Week 4
    Statistical analysis description
    Mixed effects repeated measures Analysis of Covariance (ANCOVA) model with center and subject within center as random effects, treatment, visit and visit by treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.
    Comparison groups
    Placebo v Ziprasidone
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0005
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -5.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.12
         upper limit
    		 -2.31
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.48

    Secondary: Change from Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3

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    End point title
    		 Change from Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3
    End point description
    YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania. ITT population. ‘n’ signifies those subjects who were available for this measure at given time points for each group respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 2, 3
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    131 [1]
    85 [2]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Change at Week 1 (n=131,85)
    -9.3 ± 7.5
    -6.3 ± 7.1
        Change at Week 2 (n=120,81)
    -11.5 ± 8.7
    -8.1 ± 7.9
        Change at Week 3 (n=108,65)
    -13 ± 8.1
    -9 ± 7.3
    Notes
    [1] - Subjects who were available for this measure.
    [2] - Subjects who were available for this measure.
    Statistical analysis title
    		 Change at Week 1
    Statistical analysis description
    Mixed effects repeated measures ANCOVA model with center and subject within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0006
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -3.2545
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.1045
         upper limit
    		 -1.4046
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.9422
    Statistical analysis title
    		 Change at Week 2
    Statistical analysis description
    Mixed effects repeated measures ANCOVA model with center and subject within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0117
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -3.5857
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.3705
         upper limit
    		 -0.8009
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.4184
    Statistical analysis title
    		 Change at Week 3
    Statistical analysis description
    Mixed effects repeated measures ANCOVA model with center and subject within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0047
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -4.8665
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.2345
         upper limit
    		 -1.4985
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.7154

    Secondary: Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4

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    End point title
    		 Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4
    End point description
    CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill). ITT population. Here, ‘n’ signifies those subjects who were available for this measure at given time points for each group respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 2, 3, 4
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    143
    86
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n=143,86)
    4.5 ± 0.7
    4.5 ± 0.7
        Change at Week 1 (n=131,85)
    -0.9 ± 0.8
    -0.5 ± 0.9
        Change at Week 2 (n=120,82)
    -1.1 ± 1
    -0.6 ± 0.9
        Change at Week 3 (n=108,65)
    -1.3 ± 1
    -0.7 ± 1
        Change at Week 4 (n=96,51)
    -1.4 ± 1.1
    -0.9 ± 0.9
    Statistical analysis title
    		 Change at Week 1
    Statistical analysis description
    Mixed effects repeated measures ANCOVA model with center and subject within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.3754
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5696
         upper limit
    		 -0.1812
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0989
    Statistical analysis title
    		 Change at Week 2
    Statistical analysis description
    Mixed effects repeated measures ANCOVA model with center and subject within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.5596
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8256
         upper limit
    		 -0.2936
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1355
    Statistical analysis title
    		 Change at Week 3
    Statistical analysis description
    Mixed effects repeated measures ANCOVA model with center and subject within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.6798
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.0024
         upper limit
    		 -0.3572
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1643
    Statistical analysis title
    		 Change at Week 4
    Statistical analysis description
    Mixed effects repeated measures ANCOVA model with center and subject within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.6884
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.0342
         upper limit
    		 -0.3426
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1761

    Secondary: Clinical Global Impression - Improvement (CGI-I) Score

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    End point title
    		 Clinical Global Impression - Improvement (CGI-I) Score
    End point description
    CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. ITT population. ‘n’ signifies those subjects who were available for this measure at given time points for each group respectively.
    End point type
    Secondary
    End point timeframe
    Week 1, 2, 3, 4
    End point values
    		 Ziprasidone Placebo
    Number of subjects analysed
    132 [3]
    85 [4]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 1 (n=132,85)
    2.8 ± 0.9
    3.4 ± 0.9
        Week 2 (n=120,82)
    2.5 ± 1.1
    3.2 ± 1.1
        Week 3 (n=108,65)
    2.4 ± 1
    3.1 ± 1.3
        Week 4 (n=96,51)
    2.3 ± 1
    2.8 ± 1.1
    Notes
    [3] - Subjects who were evaluable for this measure.
    [4] - Subjects who were evaluable for this measure.
    Statistical analysis title
    		 Change at Week 4
    Statistical analysis description
    Mixed effects repeated measures ANCOVA model with center and subject within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects was used for the analysis.
    Comparison groups
    Ziprasidone v Placebo
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0004
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.18
         upper limit
    		 -0.34
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.21

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 6 days after last dose of study drug
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both serious, nonserious event during study. EU BR specific AE tables were generated separately as per EU format using latest coding.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Ziprasidone
    Reporting group description
    		 Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 mg/day as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for subjects with >=45 kg weight and ziprasidone 60 to 80 mg/day for subjects with <45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for subjects with >=45 kg weight and ziprasidone capsule 40 to 80 mg/day for subjects with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matched to ziprasidone capsule orally twice daily up to Week 4.

    Serious adverse events
    		 Ziprasidone Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 149 (4.03%)
    5 / 88 (5.68%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Dystonia
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    1 / 149 (0.67%)
    3 / 88 (3.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aggression
         subjects affected / exposed
    1 / 149 (0.67%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paranoia
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersexuality
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Self-injurious ideation
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar I disorder
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Viral infection
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 88 (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
    		 Ziprasidone Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    128 / 149 (85.91%)
    42 / 88 (47.73%)
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    6 / 149 (4.03%)
    5 / 88 (5.68%)
         occurrences all number
    6
    5
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    8 / 149 (5.37%)
    1 / 88 (1.14%)
         occurrences all number
    9
    1
    Dizziness
         subjects affected / exposed
    19 / 149 (12.75%)
    2 / 88 (2.27%)
         occurrences all number
    23
    2
    Tremor
         subjects affected / exposed
    9 / 149 (6.04%)
    0 / 88 (0.00%)
         occurrences all number
    11
    0
    Somnolence
         subjects affected / exposed
    37 / 149 (24.83%)
    7 / 88 (7.95%)
         occurrences all number
    43
    7
    Headache
         subjects affected / exposed
    33 / 149 (22.15%)
    19 / 88 (21.59%)
         occurrences all number
    40
    22
    Sedation
         subjects affected / exposed
    49 / 149 (32.89%)
    5 / 88 (5.68%)
         occurrences all number
    55
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    23 / 149 (15.44%)
    6 / 88 (6.82%)
         occurrences all number
    23
    6
    Eye disorders
    Vision blurred
         subjects affected / exposed
    9 / 149 (6.04%)
    1 / 88 (1.14%)
         occurrences all number
    9
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    21 / 149 (14.09%)
    6 / 88 (6.82%)
         occurrences all number
    24
    6
    Abdominal pain upper
         subjects affected / exposed
    8 / 149 (5.37%)
    3 / 88 (3.41%)
         occurrences all number
    8
    3
    Vomiting
         subjects affected / exposed
    12 / 149 (8.05%)
    1 / 88 (1.14%)
         occurrences all number
    15
    1
    Psychiatric disorders
    Restlessness
         subjects affected / exposed
    8 / 149 (5.37%)
    1 / 88 (1.14%)
         occurrences all number
    8
    1
    Insomnia
         subjects affected / exposed
    14 / 149 (9.40%)
    3 / 88 (3.41%)
         occurrences all number
    18
    3
    Musculoskeletal and connective tissue disorders
    Musculoskeletal stiffness
         subjects affected / exposed
    8 / 149 (5.37%)
    0 / 88 (0.00%)
         occurrences all number
    8
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 149 (5.37%)
    0 / 88 (0.00%)
         occurrences all number
    8
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Dec 2006
    1- Change in Trial Treatment to indicate that dosing adjustments could be made between 40-80 mg/day for subjects weighing under 45 kg.

    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
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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