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    Clinical Trial Results:
    A Phase 3, Multicenter, Open-label, 12-month Extension Safety and Tolerability Study of SPD489 in the Treatment of Adults with Binge Eating Disorder

    Summary
    EudraCT number
    2012-003313-34
    Trial protocol
    SE   DE   IT   ES  
    Global end of trial date
    21 Oct 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    SPD489-345
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01657019
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Shire Development, LLC
    Sponsor organisation address
    725 Chesterbrook Boulevard, Wayne, United States, 19087
    Public contact
    Study Physician, Shire Development, LLC, +1 866 842 5335,
    Scientific contact
    Study Physician, Shire Development, LLC, +1 866 842 5335,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Oct 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety and tolerability of SPD489 (50 and 70mg/day) for the treatment of BED in adults 18-55 years of age (inclusive at the time of consent for the respective antecedent SPD489 BED trial). Long-term safety will be described using: 1. Occurrence of TEAEs. 2. Response to the Columbia Suicide Severity Rating Scale (C-SSRS). 3. Specific evaluation of blood pressure and pulse, weight and waist circumference, clinical laboratory evaluations, and ECG results.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation of Good Clinical Practice, the principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    21 Aug 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    Germany: 16
    Country: Number of subjects enrolled
    United States: 580
    Worldwide total number of subjects
    604
    EEA total number of subjects
    24
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    604
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This was an open-label extension study to evaluate the long-term safety of SPD489 in adults aged 18-55 years with binge eating disorder (BED) who completed 1 of 3 antecedent studies, all of which tested SPD489 for BED (SPD489-208, SPD489-343, or SPD489-344).

    Pre-assignment
    Screening details
    Subjects were screened for eligibility over a period of 2 weeks.

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

    Arms
    Arm title
    All participants
    Arm description
    Subjects initially received lisdexamfetamine dimesylate, 30 mg, during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg. Subjects received treatment for a total of 52 weeks, then were followed for 1 week.
    Arm type
    Experimental

    Investigational medicinal product name
    lisdexamfetamine dimesylate
    Investigational medicinal product code
    Other name
    Vyvanse, SPD489, LDX
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects initially received lisdexamfetamine dimesylate as a 30 mg capsule administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either a 50 or 70 mg capsule administered orally, once daily.

    Number of subjects in period 1
    All participants
    Started
    604
    Completed
    369
    Not completed
    235
         Protocol violation
    6
         Not specified
    58
         Adverse event
    55
         Lost to follow-up
    48
         Withdrawal by subject
    65
         Lack of efficacy
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    All participants
    Reporting group description
    Subjects initially received lisdexamfetamine dimesylate, 30 mg, during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg. Subjects received treatment for a total of 52 weeks, then were followed for 1 week.

    Reporting group values
    All participants Total
    Number of subjects
    604 604
    Age categorical
    Units: Subjects
        < 40 years
    302 302
        >/= 40 years
    302 302
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    39.1 ( 9.99 ) -
    Gender categorical
    Units: Subjects
        Female
    525 525
        Male
    79 79

    End points

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    End points reporting groups
    Reporting group title
    All participants
    Reporting group description
    Subjects initially received lisdexamfetamine dimesylate, 30 mg, during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg. Subjects received treatment for a total of 52 weeks, then were followed for 1 week.

    Primary: Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety

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    End point title
    Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety [1]
    End point description
    This endpoint analyzed the Safety Analysis Set (SAS), defined as all subjects who took at least 1 dose of investigational product and who had at least 1 post­Visit 0 safety assessment in the study.
    End point type
    Primary
    End point timeframe
    52 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this open label study was focused on continued safety, no formal analysis was performed as only descriptive statistics were used.
    End point values
    All participants
    Number of subjects analysed
    599
    Units: percentage of subjects
    number (not applicable)
        Any TEAE
    84.5
        Serious TEAEs
    2.8
    No statistical analyses for this end point

    Primary: Number of Subjects With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS)

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    End point title
    Number of Subjects With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) [2]
    End point description
    Suicidality was assessed by using the C-SSRS, a semi-structured interview designed to capture the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview and rating for the C-SSRS was completed by a clinician who had been successfully trained. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answers to the first 2 ideation questions were "yes," the clinician asked questions 3-5. Active suicidal ideation included any subject who answered "yes" to questions 2-5. If the answers to ideation questions 1 and 2 were "no," then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide. This endpoint analysed the SAS.
    End point type
    Primary
    End point timeframe
    53 weeks
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this open label study was focused on continued safety, no formal analysis was performed as only descriptive statistics were used.
    End point values
    All participants
    Number of subjects analysed
    597
    Units: subjects
        Suicidal behavior
    0
        Active suicidal ideation
    2
        Non-suicidal self-injurious behavior
    3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale

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    End point title
    Percentage of Subjects With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale
    End point description
    The CGI rating scales permitted the global evaluation of a subject's condition severity and improvement over time. The CGI-I was performed to rate the improvement of a subject's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse) and included a 'not assessed' option. The responses were dichotomized into 2 categories (improved or not improved). Improved included very much improved and much improved; not improved included minimally improved, no change, minimally worse, much worse, and very much worse. Not assessed and missing values were excluded from the percentage calculation. This endpoint analyzed the Full Analysis Set (FAS), defined as all subjects in the SAS who had at least 1 post-Visit 0 clinical experience outcome assessment in this study.
    End point type
    Secondary
    End point timeframe
    Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)
    End point values
    All participants
    Number of subjects analysed
    597
    Units: percentage of subjects
    number (confidence interval 95%)
        Visit 1 (Week 1), n=589
    53.7 (49.6 to 57.7)
        Visit 4 (Week 4), n=572
    88.5 (85.8 to 91.1)
        Visit 9 (Week 24), n=466
    92.7 (90.3 to 95.1)
        Visit 16 (Week 52), n=369
    95.4 (93.2 to 97.5)
        End of Treatment, n=597
    89.9 (87.5 to 92.3)
    No statistical analyses for this end point

    Secondary: Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q)

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    End point title
    Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q)
    End point description
    The EDE-Q is a 28-item questionnaire measuring eating pathology and is derived directly from the Eating Disorder Examination Interview. The EDE-Q focuses on the past 28 days to assess the main behavioral (eating and purging) and attitudinal features of eating disorders. The 28 items are rated by the subject on a 7-point scale (ranging from 0 to 6), with higher scores indicating increased pathology. The EDE-Q includes 4 subscales: Restraint, Eating Concern, Weight Concern, and Shape Concern. The global score is the average of all 28 items, with a range of 0 to 6. A negative value indicates a favorable result. The values presented are the mean change from baseline. This endpoint analyzed the FAS.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)
    End point values
    All participants
    Number of subjects analysed
    597
    Units: units on a scale
    arithmetic mean (standard deviation)
        Visit 4 (Week 4), n=483
    -1.66 ( 1.156 )
        Visit 9 (Week 24), n=391
    -1.95 ( 1.271 )
        Visit 16 (Week 52), n=314
    -1.95 ( 1.261 )
        End of Treatment, n=503
    -1.9 ( 1.284 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility

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    End point title
    Percentage of Subjects With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility
    End point description
    The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of subjects with various responses to the mobility questionnaire are reported. Percentages are based on all subjects in the Full Analysis Set with a valid result at the given visit. This endpoint analyzed the FAS.
    End point type
    Secondary
    End point timeframe
    End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
    End point values
    All participants
    Number of subjects analysed
    555
    Units: percentage of subjects at ET
    number (not applicable)
        I have no problems in walking about
    91.2
        I have slight problems in walking about
    6.8
        I have moderate problems in walking about
    1.4
        I have severe problems in walking about
    0.4
        I am unable to walk about
    0.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care

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    End point title
    Percentage of Subjects With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care
    End point description
    The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of subjects with various responses to the self care questionnaire are reported. Percentages are based on all subjects in the Full Analysis Set with a valid result at the given visit. This endpoint analyzed the FAS
    End point type
    Secondary
    End point timeframe
    End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
    End point values
    All participants
    Number of subjects analysed
    555
    Units: percentage of subjects at ET
    number (not applicable)
        I have no problems washing or dressing myself
    97.1
        I have slight problems washing or dressing myself
    1.8
        Moderate problems washing or dressing myself
    0.7
        I have severe problems washing or dressing myself
    0.2
        I am unable to wash or dress myself
    0.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities

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    End point title
    Percentage of Subjects With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities
    End point description
    The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of subjects with various responses to the usual activities questionnaire are reported. Percentages are based on all subjects in the Full Analysis Set with a valid result at the given visit. This endpoint analyzed the FAS.
    End point type
    Secondary
    End point timeframe
    End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
    End point values
    All participants
    Number of subjects analysed
    555
    Units: percentage of subjects at ET
    number (not applicable)
        I have no problems doing my usual activities
    88.5
        I have slight problems doing my usual activities
    8.3
        Moderate problems doing my usual activities
    2.2
        I have severe problems doing my usual activities
    0.9
        I am unable to do my usual activities
    0.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort

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    End point title
    Percentage of Subjects With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort
    End point description
    The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of subjects with various responses to the pain/discomfort questionnaire are reported. Percentages are based on all subjects in the Full Analysis Set with a valid result at the given visit. This endpoint analyzed the FAS.
    End point type
    Secondary
    End point timeframe
    End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
    End point values
    All participants
    Number of subjects analysed
    555
    Units: percentage of subjects at ET
    number (not applicable)
        I have no pain or discomfort
    71.2
        I have slight pain or discomfort
    20.9
        I have moderate pain or discomfort
    7
        I have severe pain or discomfort
    0.9
        I have extreme pain or discomfort
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression

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    End point title
    Percentage of Subjects With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression
    End point description
    The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of subjects with various responses to the anxiety/depression questionnaire are reported. Percentages are based on all subjects in the Full Analysis Set with a valid result at the given visit. This endpoint analyzed the FAS.
    End point type
    Secondary
    End point timeframe
    End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
    End point values
    All participants
    Number of subjects analysed
    555
    Units: percentage of subjects at ET
    number (not applicable)
        I am not anxious or depressed
    75.9
        I am slightly anxious or depressed
    18.7
        I am moderately anxious or depressed
    4.5
        I am severely anxious or depressed
    0.9
        I am extremely anxious or depressed
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    53 weeks
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    All participants
    Reporting group description
    Subjects initially received lisdexamfetamine dimesylate, 30 mg, during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg. Subjects received treatment for a total of 52 weeks, then were followed for 1 week.

    Serious adverse events
    All participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 599 (2.84%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    1 / 599 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    1 / 599 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 599 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 599 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 599 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 599 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 599 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 599 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 599 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Intestinal perforation
         subjects affected / exposed
    1 / 599 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 599 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    2 / 599 (0.33%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 599 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 599 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Adjustment disorder with anxiety
         subjects affected / exposed
    1 / 599 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 599 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    1 / 599 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 599 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Helicobacter infection
         subjects affected / exposed
    1 / 599 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 599 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    All participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    447 / 599 (74.62%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    26 / 599 (4.34%)
         occurrences all number
    29
    Heart rate increased
         subjects affected / exposed
    15 / 599 (2.50%)
         occurrences all number
    17
    Weight decreased
         subjects affected / exposed
    19 / 599 (3.17%)
         occurrences all number
    21
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    14 / 599 (2.34%)
         occurrences all number
    16
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    21 / 599 (3.51%)
         occurrences all number
    23
    Headache
         subjects affected / exposed
    79 / 599 (13.19%)
         occurrences all number
    103
    Hypoaesthesia
         subjects affected / exposed
    15 / 599 (2.50%)
         occurrences all number
    21
    Paraesthesia
         subjects affected / exposed
    14 / 599 (2.34%)
         occurrences all number
    15
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    28 / 599 (4.67%)
         occurrences all number
    29
    Feeling jittery
         subjects affected / exposed
    30 / 599 (5.01%)
         occurrences all number
    33
    Irritability
         subjects affected / exposed
    36 / 599 (6.01%)
         occurrences all number
    47
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    41 / 599 (6.84%)
         occurrences all number
    42
    Diarrhoea
         subjects affected / exposed
    26 / 599 (4.34%)
         occurrences all number
    29
    Dry mouth
         subjects affected / exposed
    163 / 599 (27.21%)
         occurrences all number
    175
    Nausea
         subjects affected / exposed
    41 / 599 (6.84%)
         occurrences all number
    45
    Toothache
         subjects affected / exposed
    12 / 599 (2.00%)
         occurrences all number
    12
    Vomiting
         subjects affected / exposed
    15 / 599 (2.50%)
         occurrences all number
    17
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    16 / 599 (2.67%)
         occurrences all number
    16
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    30 / 599 (5.01%)
         occurrences all number
    36
    Bruxism
         subjects affected / exposed
    35 / 599 (5.84%)
         occurrences all number
    35
    Initial insomnia
         subjects affected / exposed
    25 / 599 (4.17%)
         occurrences all number
    26
    Insomnia
         subjects affected / exposed
    74 / 599 (12.35%)
         occurrences all number
    80
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    16 / 599 (2.67%)
         occurrences all number
    17
    Back pain
         subjects affected / exposed
    16 / 599 (2.67%)
         occurrences all number
    18
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    14 / 599 (2.34%)
         occurrences all number
    14
    Gastroenteritis viral
         subjects affected / exposed
    18 / 599 (3.01%)
         occurrences all number
    19
    Influenza
         subjects affected / exposed
    16 / 599 (2.67%)
         occurrences all number
    16
    Nasopharyngitis
         subjects affected / exposed
    53 / 599 (8.85%)
         occurrences all number
    65
    Sinusitis
         subjects affected / exposed
    35 / 599 (5.84%)
         occurrences all number
    38
    Upper respiratory tract infection
         subjects affected / exposed
    68 / 599 (11.35%)
         occurrences all number
    81
    Urinary tract infection
         subjects affected / exposed
    27 / 599 (4.51%)
         occurrences all number
    28
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    36 / 599 (6.01%)
         occurrences all number
    37

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Sep 2012
    Amendment 1 included the following important changes: • Clarified pregnancy testing requirements in the inclusion criteria • Clarified inclusion criteria to state that a subject must have a BED diagnosis as confirmed by the eating disorder module of the SCID-I and EDE-Q from the antecedent study • Clarified exclusion criteria to state that if a subject had any clinically significant ECG or laboratory abnormality at the Screening Visit (Visit -1), if applicable or Visit 0, the subject would be excluded • Clarified exclusion criteria to state that pregnant or nursing females would be excluded • Clarified that female subjects must have had a negative serum pregnancy test at study entry (Visit 0) and a negative urine pregnancy test at Visit 0, and added that contraception requirements were to be reviewed at every study visit and recorded in the source documents • Added monthly urine pregnancy tests to the planned study procedures • Added assessment of the suitability of the subject to remain in the study, which was to be conducted at all visits • Added details clarifying fasting laboratory procedures • Clarified that demographic information was to be taken from the antecedent study database for subjects completing the Screening Visit • Added that no psychoactive medication use would be permitted during the study, and that use within 5 times the half-life of the medication before study entry would be exclusionary • Clarified various details related to commonly excluded prior and concomitant medications.
    22 May 2013
    Amendment 2 included the following important changes: • Updated emergency reporting time. • Clarified pregnancy testing requirements in the inclusion criteria • Clarified the state that a current diagnosis rather than concurrent symptoms of bulimia nervosa or anorexia nervosa is exclusionary. • Removed distribute daily diary at Visit 3 in Table 1. • Added suitability to remain in the study to Visit 16(ET) in Table 1 and Table 2 • Added an Overall Risk/Benefit Assessment to Section 1. • Clarified that the time frame subjects were permitted to receive psychotherapy intervention for binge eating disorder (BED). • Clarified that the Mini International Neuropsychiatric Interview Plus (MINI-Plus) will be completed to exclude comorbid Axis I disorders. • Clarified that a urine drug screen will be conducted at the Screening Visit (Visit -1) only for subjects who enroll 30 days from completion of the antecedent study. • Added Suitability to Remain in the Study. • Added adverse event (AE) reporting requirements for a change in vital signs and electrocardiogram (ECG) results. • Added protocol history appendix.

    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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