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    Clinical Trial Results:
    A Randomized, Open-Label Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Single and Multiple Doses of Armodafinil (50, 100, and 150 mg/day) in Children and Adolescents with Excessive Sleepiness Associated With Narcolepsy

    Summary
    EudraCT number
    		 2012-005510-20
    Trial protocol
    		 FI  
    Global end of trial date
    21 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Nov 2016
    First version publication date
    23 Nov 2016
    Other versions
    Summary report(s)
    		 Sponsors statement concerning unavailability of paediatric clinical trial results_EudraCT 2012-005510-20

    Trial information

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    Trial identification
    Sponsor protocol code
    C10953/1100
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01624480
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Teva Branded Pharmaceutical Products R&D, Inc
    Sponsor organisation address
    41 Moores Road, Frazer, Pennsylvania, United States, 19355
    Public contact
    Director, Clinical Research, Teva Branded Pharmaceutical Products, R&D Inc., 001 215-591-3000, ustevatrials@tevapharm.com
    Scientific contact
    Director, Clinical Research, Teva Branded Pharmaceutical Products, R&D Inc., 001 215-591-3000, ustevatrials@tevapharm.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 May 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to characterize the single- and multiple-dose pharmacokinetics of armodafinil and its major circulating metabolites (R-modafinil acid and modafinil sulfone) in children and adolescents with excessive sleepiness associated with narcolepsy.
    Protection of trial subjects
    This study was conducted in full accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Consolidated Guideline (E6) and any applicable national and local laws and regulations (eg, Code of Federal Regulations [CFR] Title 21, Parts 50, 54, 56, 312, and 314; European Union (EU) Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use). A signed and dated informed consent form was obtained from each parent/guardian and a signed and dated assent form was obtained from each patient before any study-specific procedures or assessments were done and after the aims, methods, anticipated benefits, and potential hazards were explained, according to local IRB/IEC requirements. The patient’s willingness to participate in the study was documented in this assent form, which was signed by the patient with the date of that signature indicated. Each investigator kept the original consent/assent forms and copies were given to the patients. It was also explained to the patients that they were free to refuse entry into the study and free to withdraw from the study at any time without prejudice to future treatment. Written and/or oral information about the study in a language understandable by the patient was given to all patients.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Jul 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 40
    Worldwide total number of subjects
    40
    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)
    10
    Adolescents (12-17 years)
    30
    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
    		 -

    Pre-assignment
    Screening details
    		 Sixty-one patients were screened and 40 enrolled/randomized. Of the 21 not enrolled, 4 were withdrawn by patient, 6 did not meet inclusion criteria, 9 met exclusion criteria, 1 was lost to follow-up, and 1 whose reason was not specified.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Armodafinil 50 mg
    Arm description
    		 Patients received a single 50 mg dose of armodafinil on day 1. No intervention was administered on days 2+3. Patients received a single 50 mg daily dose of armodafinil on days 4-25. All doses of armodafinil must have been taken intact with up to 240 mL of water and the entire dose must have been consumed within 5 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    armodafinil
    Investigational medicinal product code
    Other name
    Nuvigil, CEP-10953
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Armodafinil was supplied as 50 mg tablets. Patients took the appropriate number of tablets for their assigned 50 mg, 100 mg or 150 mg daily dose. For a given patient, study drug was taken within the same 2-hour window in the morning on each day of study drug administration. Each patient’s 2-hour window for study drug administration must have fallen between 0600 and 1000.

    Arm title
    		 Armodafinil 100 mg
    Arm description
    		 Patients received a single 50 mg dose of armodafinil on day 1. No intervention was administered on days 2+3. Patients received a single 50 mg dose on day 4 then daily 100 mg doses on days 5 - 25. All doses of armodafinil must have been taken intact with up to 240 mL of water and the entire dose must have been consumed within 5 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    armodafinil
    Investigational medicinal product code
    Other name
    Nuvigil, CEP-10953
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Armodafinil was supplied as 50 mg tablets. Patients took the appropriate number of tablets for their assigned 50 mg, 100 mg or 150 mg daily dose. For a given patient, study drug was taken within the same 2-hour window in the morning on each day of study drug administration. Each patient’s 2-hour window for study drug administration must have fallen between 0600 and 1000.

    Arm title
    		 Armodafinil 150 mg
    Arm description
    		 Patients received a single 50 mg dose of armodafinil on day 1. No intervention was administered on days 2+3. Patients received a single 50 mg dose on day 4, 100 mg doses on days 5 and 6, then daily 150 mg doses on days 7 through 25. All doses of armodafinil must have been taken intact with up to 240 mL of water and the entire dose must have been consumed within 5 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    armodafinil
    Investigational medicinal product code
    Other name
    Nuvigil, CEP-10953
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Armodafinil was supplied as 50 mg tablets. Patients took the appropriate number of tablets for their assigned 50 mg, 100 mg or 150 mg daily dose. For a given patient, study drug was taken within the same 2-hour window in the morning on each day of study drug administration. Each patient’s 2-hour window for study drug administration must have fallen between 0600 and 1000.

    Number of subjects in period 1
    		Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Started
    14
    13
    13
    Safety analysis set
    14
    13
    13
    Pharmacodynamic analysis set
    14
    13
    13
    Pharmacokinetic analysis set
    14
    12
    12
    Completed
    13
    12
    11
    Not completed
    1
    1
    2
         Consent withdrawn by subject
    -
    1
    1
         Lost to follow-up after first PK visit
    1
    -
    -
         Sponsor decision on day 24
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Armodafinil 50 mg
    Reporting group description
    		 Patients received a single 50 mg dose of armodafinil on day 1. No intervention was administered on days 2+3. Patients received a single 50 mg daily dose of armodafinil on days 4-25. All doses of armodafinil must have been taken intact with up to 240 mL of water and the entire dose must have been consumed within 5 minutes.

    Reporting group title
    Armodafinil 100 mg
    Reporting group description
    		 Patients received a single 50 mg dose of armodafinil on day 1. No intervention was administered on days 2+3. Patients received a single 50 mg dose on day 4 then daily 100 mg doses on days 5 - 25. All doses of armodafinil must have been taken intact with up to 240 mL of water and the entire dose must have been consumed within 5 minutes.

    Reporting group title
    Armodafinil 150 mg
    Reporting group description
    		 Patients received a single 50 mg dose of armodafinil on day 1. No intervention was administered on days 2+3. Patients received a single 50 mg dose on day 4, 100 mg doses on days 5 and 6, then daily 150 mg doses on days 7 through 25. All doses of armodafinil must have been taken intact with up to 240 mL of water and the entire dose must have been consumed within 5 minutes.

    Reporting group values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg Total
    Number of subjects
    		 14 13 13 40
    Age categorical
    Units: Subjects
        Children (6-11 years)
    		 4 3 3 10
        Adolescents (12-17 years)
    		 10 10 10 30
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 13.1 ( 2.38 ) 13.3 ( 3.07 ) 13 ( 2.68 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 4 7 17
        Male
    		 8 9 6 23
    Race
    Units: Subjects
        White
    		 7 5 4 16
        Black
    		 4 8 8 20
        Asian
    		 1 0 0 1
        Other
    		 2 0 1 3
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 12 12 13 37
        Hispanic or Latino
    		 2 1 0 3
    Clinical Global Impression of Severity (CGI-S) for Depression
    The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).
    Units: Subjects
        Normal (no signs of illness)
    		 1 1 0 2
        Borderline ill
    		 0 0 0 0
        Mildly (slightly ill)
    		 0 1 1 2
        Moderately ill
    		 7 7 4 18
        Markedly ill
    		 4 3 5 12
        Severely ill
    		 2 1 3 6
        Among the most extremely ill patients
    		 0 0 0 0
    Skin Evaluation
    Units: Subjects
        Abnormal at baseline
    		 0 0 1 1
        Normal at baseline
    		 14 13 12 39
    Electrocardiogram (ECG)
    Units: Subjects
        Normal at baseline
    		 9 10 10 29
        Abnormal at baseline
    		 5 3 3 11
    Body Mass Index
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 29 ( 7.28 ) 24.9 ( 6.77 ) 25.6 ( 5.43 ) -

    End points

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    End points reporting groups
    Reporting group title
    Armodafinil 50 mg
    Reporting group description
    		 Patients received a single 50 mg dose of armodafinil on day 1. No intervention was administered on days 2+3. Patients received a single 50 mg daily dose of armodafinil on days 4-25. All doses of armodafinil must have been taken intact with up to 240 mL of water and the entire dose must have been consumed within 5 minutes.

    Reporting group title
    Armodafinil 100 mg
    Reporting group description
    		 Patients received a single 50 mg dose of armodafinil on day 1. No intervention was administered on days 2+3. Patients received a single 50 mg dose on day 4 then daily 100 mg doses on days 5 - 25. All doses of armodafinil must have been taken intact with up to 240 mL of water and the entire dose must have been consumed within 5 minutes.

    Reporting group title
    Armodafinil 150 mg
    Reporting group description
    		 Patients received a single 50 mg dose of armodafinil on day 1. No intervention was administered on days 2+3. Patients received a single 50 mg dose on day 4, 100 mg doses on days 5 and 6, then daily 150 mg doses on days 7 through 25. All doses of armodafinil must have been taken intact with up to 240 mL of water and the entire dose must have been consumed within 5 minutes.

    Primary: Maximum observed plasma concentration (Cmax) for Armodafinil after a Single Dose (Day 1) and after Multiple Doses (Day 25)

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    End point title
    		 Maximum observed plasma concentration (Cmax) for Armodafinil after a Single Dose (Day 1) and after Multiple Doses (Day 25) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Days 1 and 25: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [2]
    12 [3]
    12 [4]
    Units: micrograms/mL
    arithmetic mean (standard deviation)
        Single-dose (Day 1)
    1.3 ( 0.214 )
    3.05 ( 1.388 )
    4.27 ( 1.048 )
        Multiple-dose (Day 25)
    1.76 ( 0.359 )
    4.22 ( 1.553 )
    5.78 ( 1.19 )
    Notes
    [2] - PK analysis set Day 1: n=14 Day 25: n=11
    [3] - PK analysis set Day 1: n=12 Day 25: n=11
    [4] - PK analysis set Day 1: n=12 Day 25: n=10
    No statistical analyses for this end point

    Primary: Time To Maximum Observed Drug Concentration (tmax) for Armodafinil after a Single Dose (Day 1) and after Multiple Doses (Day 25)

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    End point title
    		 Time To Maximum Observed Drug Concentration (tmax) for Armodafinil after a Single Dose (Day 1) and after Multiple Doses (Day 25) [5]
    End point description
    End point type
    Primary
    End point timeframe
    Days 1 and 25: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [6]
    12 [7]
    12 [8]
    Units: hours
    median (full range (min-max))
        Single-dose (Day 1)
    2 (0.5 to 4.5)
    2.4 (0.5 to 4.5)
    2.3 (0.5 to 6.6)
        Multiple-dose (Day 25)
    1 (0.5 to 4.4)
    2.3 (1 to 4.5)
    2.4 (1 to 6.5)
    Notes
    [6] - PK analysis set Day 1: n=14 Day 25: n=11
    [7] - PK analysis set Day 1: n=12 Day 25: n=11
    [8] - PK analysis set Day 1: n=12 Day 25: n=10
    No statistical analyses for this end point

    Primary: Area Under The Plasma Concentration-Time Curve From Time 0 To The Time Of The Last Measurable Drug Concentration (AUC0–t) for Armodafinil after a Single Dose (Day 1) and after Multiple Doses (Day 25)

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    End point title
    		 Area Under The Plasma Concentration-Time Curve From Time 0 To The Time Of The Last Measurable Drug Concentration (AUC0–t) for Armodafinil after a Single Dose (Day 1) and after Multiple Doses (Day 25) [9]
    End point description
    End point type
    Primary
    End point timeframe
    Days 1 and 25: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [10]
    12 [11]
    12 [12]
    Units: μg·h/mL
    arithmetic mean (standard deviation)
        Single-dose (Day 1)
    15.6 ( 3.88 )
    49.1 ( 31.88 )
    74.4 ( 23.38 )
        Multiple-dose (Day 25)
    24.6 ( 7.66 )
    85 ( 27.35 )
    119.8 ( 19.99 )
    Notes
    [10] - PK analysis set Day 1: n=14 Day 25: n=11
    [11] - PK analysis set Day 1: n=12 Day 25: n=11
    [12] - PK analysis set Day 1: n=12 Day 25: n=10
    No statistical analyses for this end point

    Primary: Area Under The Plasma Concentration-Time Curve From Time 0 To Infinity (AUC0–∞) for Armodafinil after a Single Dose (Day 1)

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    End point title
    		 Area Under The Plasma Concentration-Time Curve From Time 0 To Infinity (AUC0–∞) for Armodafinil after a Single Dose (Day 1) [13]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    13 [14]
    10 [15]
    12 [16]
    Units: μg·h/mL
        arithmetic mean (standard deviation)
    21.1 ( 5.06 )
    57.2 ( 33.33 )
    82.8 ( 24.06 )
    Notes
    [14] - PK analysis set
    [15] - PK analysis set
    [16] - PK analysis set
    No statistical analyses for this end point

    Primary: Extrapolation for Armodafinil after a Single Dose (Day 1)

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    End point title
    		 Extrapolation for Armodafinil after a Single Dose (Day 1) [17]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    13 [18]
    10 [19]
    12 [20]
    Units: percentage
        arithmetic mean (standard deviation)
    26.4 ( 8.41 )
    18.9 ( 8.1 )
    10.8 ( 5 )
    Notes
    [18] - PK analysis set
    [19] - PK analysis set
    [20] - PK analysis set
    No statistical analyses for this end point

    Primary: Area Under The Plasma Concentration-Time Curve For One Dosing Interval Of A Multiple-Dose Regimen (AUCτ) for Armodafinil (Day 25)

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    End point title
    		 Area Under The Plasma Concentration-Time Curve For One Dosing Interval Of A Multiple-Dose Regimen (AUCτ) for Armodafinil (Day 25) [21]
    End point description
    End point type
    Primary
    End point timeframe
    Day 25: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    11 [22]
    11 [23]
    10 [24]
    Units: μg·h/mL
        arithmetic mean (standard deviation)
    23.3 ( 4.91 )
    61.6 ( 20.33 )
    86.2 ( 13.83 )
    Notes
    [22] - PK analysis set
    [23] - PK analysis set
    [24] - PK analysis set
    No statistical analyses for this end point

    Primary: Half-Life (t1/2) for Armodafinil after a Single Dose (Day 1) and after Multiple Doses (Day 25)

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    End point title
    		 Half-Life (t1/2) for Armodafinil after a Single Dose (Day 1) and after Multiple Doses (Day 25) [25]
    End point description
    End point type
    Primary
    End point timeframe
    Days 1 and 25: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [26]
    12 [27]
    12 [28]
    Units: hours
    arithmetic mean (standard deviation)
        Single-dose (Day 1)
    11.1 ( 2.15 )
    12.1 ( 2.23 )
    12.8 ( 4.18 )
        Multiple-dose (Day 25)
    12.6 ( 1.98 )
    14.1 ( 2.54 )
    13.8 ( 2.88 )
    Notes
    [26] - PK analysis set Day 1: n=13 Day 25: n=11
    [27] - PK analysis set Day 1: n=10 Day 25: n=11
    [28] - PK analysis set Day 1: n=12 Day 25: n=10
    No statistical analyses for this end point

    Primary: Apparent Total Clearance (CL/F) for Armodafinil after a Single Dose (Day 1) and after Multiple Doses (Day 25)

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    End point title
    		 Apparent Total Clearance (CL/F) for Armodafinil after a Single Dose (Day 1) and after Multiple Doses (Day 25) [29]
    End point description
    End point type
    Primary
    End point timeframe
    Days 1 and 25: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [30]
    12 [31]
    12 [32]
    Units: mL/minute
    arithmetic mean (standard deviation)
        Single-dose (Day 1)
    41.7 ( 10.77 )
    34.7 ( 11.95 )
    32.4 ( 8.86 )
        Multiple-dose (Day 25)
    37.3 ( 8.27 )
    28.9 ( 6.42 )
    29.7 ( 4.97 )
    Notes
    [30] - PK analysis set Day 1: n=13 Day 25: n=11
    [31] - PK analysis set Day 1: n=10 Day 25: n=11
    [32] - PK analysis set Day 1: n=12 Day 25: n=10
    No statistical analyses for this end point

    Primary: Apparent Volume of Distribution (Vz/F) for Armodafinil after a Single Dose (Day 1) and after Multiple Doses (Day 25)

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    End point title
    		 Apparent Volume of Distribution (Vz/F) for Armodafinil after a Single Dose (Day 1) and after Multiple Doses (Day 25) [33]
    End point description
    End point type
    Primary
    End point timeframe
    Days 1 and 25: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [34]
    12 [35]
    12 [36]
    Units: liters
    arithmetic mean (standard deviation)
        Single-dose (Day 1)
    39 ( 8.33 )
    35.3 ( 10.55 )
    34 ( 6.71 )
        Multiple-dose (Day 25)
    40.2 ( 8.93 )
    35.5 ( 9.84 )
    35.6 ( 12.68 )
    Notes
    [34] - PK analysis set Day 1: n=13 Day 25: n=11
    [35] - PK analysis set Day 1: n=10 Day 25: n=11
    [36] - PK analysis set Day 1: n=12 Day 25: n=10
    No statistical analyses for this end point

    Primary: Predicted Accumulation Ratio (Rpred) for Armodafinil after a Single Dose (Day 1)

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    End point title
    		 Predicted Accumulation Ratio (Rpred) for Armodafinil after a Single Dose (Day 1) [37]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    13 [38]
    10 [39]
    12 [40]
    Units: ratio
        arithmetic mean (standard deviation)
    1.3 ( 0.11 )
    1.4 ( 0.15 )
    1.5 ( 0.26 )
    Notes
    [38] - PK analysis set
    [39] - PK analysis set
    [40] - PK analysis set
    No statistical analyses for this end point

    Primary: Observed Accumulation Ratio (Robs) for Armodafinil after Multiple Doses (Day 25)

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    End point title
    		 Observed Accumulation Ratio (Robs) for Armodafinil after Multiple Doses (Day 25) [41]
    End point description
    End point type
    Primary
    End point timeframe
    Day 25: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    11 [42]
    11 [43]
    10 [44]
    Units: ratio
        arithmetic mean (standard deviation)
    1.5 ( 0.24 )
    1.6 ( 0.28 )
    1.5 ( 0.24 )
    Notes
    [42] - PK analysis set
    [43] - PK analysis set
    [44] - PK analysis set
    No statistical analyses for this end point

    Primary: Steady-State Accumulation Ratio (Rss) for Armodafinil after Multiple Doses (Day 25)

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    End point title
    		 Steady-State Accumulation Ratio (Rss) for Armodafinil after Multiple Doses (Day 25) [45]
    End point description
    End point type
    Primary
    End point timeframe
    Day 25: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    10 [46]
    9 [47]
    10 [48]
    Units: ratio
        arithmetic mean (standard deviation)
    1.1 ( 0.18 )
    1.2 ( 0.27 )
    1 ( 0.22 )
    Notes
    [46] - PK analysis set
    [47] - PK analysis set
    [48] - PK analysis set
    No statistical analyses for this end point

    Primary: Mean Trough Plasma Armodafinil Concentrations Following Once-Daily Oral Doses of Armodafinil on Days 11, 18 and 25

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    End point title
    		 Mean Trough Plasma Armodafinil Concentrations Following Once-Daily Oral Doses of Armodafinil on Days 11, 18 and 25 [49]
    End point description
    End point type
    Primary
    End point timeframe
    Days 11, 18, 25
    Notes
    [49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [50]
    12 [51]
    12 [52]
    Units: μg/mL
    arithmetic mean (standard deviation)
        Day 11
    0.566 ( 0.303 )
    1.472 ( 0.5004 )
    2.075 ( 0.9509 )
        Day 18
    0.511 ( 0.1695 )
    1.558 ( 0.4242 )
    2.348 ( 0.4494 )
        Day 25
    0.478 ( 0.2355 )
    1.456 ( 0.7369 )
    1.976 ( 0.6857 )
    Notes
    [50] - PK analysis set Day 11: 12 patients Day 18: 10 patients Day 25: 11 patients
    [51] - PK analysis set Day 11: 9 patients Day 18: 8 patients Day 25: 10 patients
    [52] - PK analysis set Day 11: 10 patients Day 18: 10 patients Day 25: 10 patients
    No statistical analyses for this end point

    Primary: Maximum observed plasma concentration (Cmax) for R-Modafinil Acid after a Single Dose (Day 1) and after Multiple Doses (Day 25)

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    End point title
    		 Maximum observed plasma concentration (Cmax) for R-Modafinil Acid after a Single Dose (Day 1) and after Multiple Doses (Day 25) [53]
    End point description
    End point type
    Primary
    End point timeframe
    Days 1 and 25: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [53] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [54]
    12 [55]
    12 [56]
    Units: μg/mL
    arithmetic mean (standard deviation)
        Single-dose (Day 1)
    0 ( 0 )
    0.17 ( 0.161 )
    0.37 ( 0.207 )
        Multiple-dose (Day 25)
    0.04 ( 0.087 )
    0.39 ( 0.093 )
    0.51 ( 0.162 )
    Notes
    [54] - K analysis set Day 1: n=14 Day 25: n=11
    [55] - K analysis set Day 1: n=12 Day 25: n=11
    [56] - K analysis set Day 1: n=12 Day 25: n=10
    No statistical analyses for this end point

    Primary: Time To Maximum Observed Drug Concentration (tmax) for R-Modafinil Acid after a Single Dose (Day 1) and after Multiple Doses (Day 25)

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    End point title
    		 Time To Maximum Observed Drug Concentration (tmax) for R-Modafinil Acid after a Single Dose (Day 1) and after Multiple Doses (Day 25) [57]
    End point description
    Values of 9999 = not calculable
    End point type
    Primary
    End point timeframe
    Days 1 and 25: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [57] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [58]
    12 [59]
    12 [60]
    Units: hours
    median (full range (min-max))
        Single-dose (Day 1)
    9999 (9999 to 9999)
    2.5 (1 to 4.5)
    2.5 (1 to 4.9)
        Multiple-dose (Day 25)
    2.4 (2.4 to 2.5)
    2.4 (0.6 to 4.5)
    4.1 (2 to 5.1)
    Notes
    [58] - PK analysis set Day 1: n=14 Day 25: n=2
    [59] - PK analysis set Day 1: n=7 Day 25: n=11
    [60] - PK analysis set Day 1: n=10 Day 25: n=10
    No statistical analyses for this end point

    Primary: Area Under The Plasma Concentration-Time Curve From Time 0 To The Time Of The Last Measurable Drug Concentration (AUC0–t) for R-Modafinil Acid after a Single Dose (Day 1) and after Multiple Doses (Day 25)

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    End point title
    		 Area Under The Plasma Concentration-Time Curve From Time 0 To The Time Of The Last Measurable Drug Concentration (AUC0–t) for R-Modafinil Acid after a Single Dose (Day 1) and after Multiple Doses (Day 25) [61]
    End point description
    End point type
    Primary
    End point timeframe
    Days 1 and 25: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [61] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [62]
    12 [63]
    12 [64]
    Units: μg·h/mL
    arithmetic mean (standard deviation)
        Single-dose (Day 1)
    0 ( 0 )
    1 ( 1.06 )
    3.4 ( 2.19 )
        Multiple-dose (Day 25)
    0 ( 0 )
    3.7 ( 1.82 )
    7.3 ( 4.28 )
    Notes
    [62] - PK analysis set Day 1: n=14 Day 25: n=11
    [63] - PK analysis set Day 1: n=12 Day 25: n=11
    [64] - PK analysis set Day 1: n=12 Day 25: n=10
    No statistical analyses for this end point

    Primary: Area Under The Plasma Concentration-Time Curve From Time 0 To Infinity (AUC0–∞) for R-Modafinil Acid after a Single Dose (Day 1)

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    End point title
    		 Area Under The Plasma Concentration-Time Curve From Time 0 To Infinity (AUC0–∞) for R-Modafinil Acid after a Single Dose (Day 1) [65]
    End point description
    Values of 9999 = not calculable
    End point type
    Primary
    End point timeframe
    Day 1: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [65] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [66]
    12 [67]
    12 [68]
    Units: μg·h/mL
        arithmetic mean (standard deviation)
    9999 ( 9999 )
    9999 ( 9999 )
    8.8 ( 2.54 )
    Notes
    [66] - PK analysis set
    [67] - PK analysis set
    [68] - PK analysis set
    No statistical analyses for this end point

    Primary: Extrapolation for R-Modafinil Acid after a Single Dose (Day 1)

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    End point title
    		 Extrapolation for R-Modafinil Acid after a Single Dose (Day 1) [69]
    End point description
    Values of 9999 = not calculable
    End point type
    Primary
    End point timeframe
    Day 1: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [69] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [70]
    12 [71]
    8 [72]
    Units: percentage
        arithmetic mean (standard deviation)
    9999 ( 9999 )
    9999 ( 9999 )
    48.8 ( 8.75 )
    Notes
    [70] - PK analysis set
    [71] - PK analysis set
    [72] - PK analysis set
    No statistical analyses for this end point

    Primary: Area Under The Plasma Concentration-Time Curve For One Dosing Interval Of A Multiple-Dose Regimen (AUCτ) for R-Modafinil Acid (Day 25)

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    End point title
    		 Area Under The Plasma Concentration-Time Curve For One Dosing Interval Of A Multiple-Dose Regimen (AUCτ) for R-Modafinil Acid (Day 25) [73]
    End point description
    Values of 9999 = not calculable
    End point type
    Primary
    End point timeframe
    Day 25: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [73] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [74]
    4 [75]
    8 [76]
    Units: μg·h/mL
        arithmetic mean (standard deviation)
    9999 ( 9999 )
    6.8 ( 0.98 )
    8.5 ( 2.89 )
    Notes
    [74] - PK analysis set
    [75] - PK analysis set
    [76] - PK analysis set
    No statistical analyses for this end point

    Primary: Half-Life (t1/2) for R-Modafinil Acid after a Single Dose (Day 1) and after Multiple Doses (Day 25)

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    End point title
    		 Half-Life (t1/2) for R-Modafinil Acid after a Single Dose (Day 1) and after Multiple Doses (Day 25) [77]
    End point description
    Values of 9999 = not calculable
    End point type
    Primary
    End point timeframe
    Days 1 and 25: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [77] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [78]
    12 [79]
    12 [80]
    Units: hours
    arithmetic mean (standard deviation)
        Single-dose (Day 1)
    9999 ( 9999 )
    9999 ( 9999 )
    11.8 ( 3.97 )
        Multiple-dose (Day 25)
    9999 ( 9999 )
    14.4 ( 4.41 )
    16.6 ( 2.88 )
    Notes
    [78] - PK analysis set
    [79] - PK analysis set Day 1: n=12 Day 25: n=4
    [80] - PK analysis set Day 1: n=8 Day 25: n=6
    No statistical analyses for this end point

    Primary: Maximum observed plasma concentration (Cmax) for Modafinil Sulfone after a Single Dose (Day 1) and after Multiple Doses (Day 25)

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    End point title
    		 Maximum observed plasma concentration (Cmax) for Modafinil Sulfone after a Single Dose (Day 1) and after Multiple Doses (Day 25) [81]
    End point description
    End point type
    Primary
    End point timeframe
    Days 1 and 25: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [81] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [82]
    12 [83]
    12 [84]
    Units: μg/mL
    arithmetic mean (standard deviation)
        Single-dose (Day 1)
    0 ( 0 )
    0.23 ( 0.34 )
    0.33 ( 0.203 )
        Multiple-dose (Day 25)
    0.28 ( 0.212 )
    1.86 ( 2.179 )
    2.58 ( 1.766 )
    Notes
    [82] - PK analysis set Day 1: n=14 Day 25: n=11
    [83] - PK analysis set Day 1: n=12 Day 25: n=11
    [84] - PK analysis set Day 1: n=12 Day 25: n=10
    No statistical analyses for this end point

    Primary: Time To Maximum Observed Drug Concentration (tmax) for Modafinil Sulfone after a Single Dose (Day 1) and after Multiple Doses (Day 25)

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    End point title
    		 Time To Maximum Observed Drug Concentration (tmax) for Modafinil Sulfone after a Single Dose (Day 1) and after Multiple Doses (Day 25) [85]
    End point description
    Values of 9999 = not calculable
    End point type
    Primary
    End point timeframe
    Days 1 and 25: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [85] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [86]
    12 [87]
    12 [88]
    Units: hours
    median (full range (min-max))
        Single-dose (Day 1)
    9999 (9999 to 9999)
    24.1 (11.9 to 48)
    24 (11.7 to 48.6)
        Multiple-dose (Day 25)
    2.8 (0 to 8.2)
    8.6 (0 to 23.7)
    8.2 (0 to 22)
    Notes
    [86] - PK analysis set Day 1: n=14 Day 25: n=8
    [87] - PK analysis set Day 1: n=7 Day 25: n=11
    [88] - PK analysis set Day 1: n=10 Day 25: n=10
    No statistical analyses for this end point

    Primary: Area Under The Plasma Concentration-Time Curve From Time 0 To The Time Of The Last Measurable Drug Concentration (AUC0–t) for Modafinil Sulfone after a Single Dose (Day 1) and after Multiple Doses (Day 25)

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    End point title
    		 Area Under The Plasma Concentration-Time Curve From Time 0 To The Time Of The Last Measurable Drug Concentration (AUC0–t) for Modafinil Sulfone after a Single Dose (Day 1) and after Multiple Doses (Day 25) [89]
    End point description
    End point type
    Primary
    End point timeframe
    Days 1 and 25: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [89] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [90]
    12 [91]
    12 [92]
    Units: μg·h/mL
    arithmetic mean (standard deviation)
        Single-dose (Day 1)
    0 ( 0 )
    8.4 ( 19.28 )
    12.6 ( 11.92 )
        Multiple-dose (Day 25)
    8.6 ( 8.46 )
    93 ( 119.28 )
    114.4 ( 78.36 )
    Notes
    [90] - PK analysis set Day 1: n=14 Day 25: n=11
    [91] - PK analysis set Day 1: n=12 Day 25: n=11
    [92] - PK analysis set Day 1: n=12 Day 25: n=10
    No statistical analyses for this end point

    Primary: Area Under The Plasma Concentration-Time Curve For One Dosing Interval Of A Multiple-Dose Regimen (AUC) for Modafinil Sulfone (Day 25)

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    End point title
    		 Area Under The Plasma Concentration-Time Curve For One Dosing Interval Of A Multiple-Dose Regimen (AUC) for Modafinil Sulfone (Day 25) [93]
    End point description
    End point type
    Primary
    End point timeframe
    Day 25: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [93] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    5 [94]
    11 [95]
    10 [96]
    Units: μg·h/mL
        arithmetic mean (standard deviation)
    9.7 ( 2.21 )
    39 ( 46.39 )
    56.8 ( 38.34 )
    Notes
    [94] - PK analysis set
    [95] - PK analysis set
    [96] - PK analysis set
    No statistical analyses for this end point

    Primary: Half-Life (t1/2) for Modafinil Sulfone after a Single Dose (Day 1) and after Multiple Doses (Day 25)

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    End point title
    		 Half-Life (t1/2) for Modafinil Sulfone after a Single Dose (Day 1) and after Multiple Doses (Day 25) [97]
    End point description
    Values of 9999 = not calculable
    End point type
    Primary
    End point timeframe
    Days 1 and 25: prior to and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after administration of armodafinil
    Notes
    [97] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgement.
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [98]
    12 [99]
    12 [100]
    Units: hours
    arithmetic mean (standard deviation)
        Single-dose (Day 1)
    9999 ( 9999 )
    9999 ( 9999 )
    38.6 ( 9999 )
        Multiple-dose (Day 25)
    42.7 ( 11.13 )
    32.5 ( 5.83 )
    35.9 ( 15.46 )
    Notes
    [98] - PK analysis set Day 1: n=14 Day 25: n=3
    [99] - PK analysis set Day 1: n=14 Day 25: n=10
    [100] - PK analysis set Day 1: n=1 Day 25: n=6
    No statistical analyses for this end point

    Secondary: Patients with Treatment-Emergent Adverse Events (AE)

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    End point title
    		 Patients with Treatment-Emergent Adverse Events (AE)
    End point description
    An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Treatment-emergent AEs refer to those that began or worsened after treatment start. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 35
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [101]
    13 [102]
    13 [103]
    Units: patients
        Any AE
    9
    4
    9
        Severe AE
    0
    1
    0
        Treatment-related AE
    3
    3
    3
        Deaths
    0
    0
    0
        Other serious AEs
    0
    0
    0
        Withdrawn from study due to AE
    0
    0
    0
    Notes
    [101] - Safety analysis set
    [102] - Safety analysis set
    [103] - Safety analysis set
    No statistical analyses for this end point

    Secondary: Patients with Clinically Significant Post Baseline Laboratory Test Results

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    End point title
    		 Patients with Clinically Significant Post Baseline Laboratory Test Results
    End point description
    Outcome summarizes the number of patients with post-baseline clinically significant serum chemistry, hematology or urinalysis tests.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 25
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [104]
    13 [105]
    13 [106]
    Units: patients
    0
    0
    0
    Notes
    [104] - Safety analysis set
    [105] - Safety analysis set
    [106] - Safety analysis set
    No statistical analyses for this end point

    Secondary: Patients with Clinically Significant Post Baseline Vital Sign Results

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    End point title
    		 Patients with Clinically Significant Post Baseline Vital Sign Results
    End point description
    Summary of patients with at least one post baseline vital sign abnormality. Significance criteria for vital signs with findings are: Pulse rate (high): >=120 and increase over baseline of >=15 beats/minute Sitting systolic blood pressure (high): >=130 and increase over baseline >=20 mmHg Sitting diastolic blood pressure (high): >=85 and increase over baseline >=15 mmHg Sitting diastolic blood pressure (low): <=50 and decrease over baseline >=15 mmHg
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 35
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [107]
    13 [108]
    13 [109]
    Units: patients
        Pulse rate (high)
    0
    2
    1
        Sitting systolic blood pressure (high)
    7
    5
    5
        Sitting diastolic blood pressure (high)
    3
    5
    5
        Sitting diastolic blood pressure (low)
    2
    0
    1
    Notes
    [107] - Safety analysis set
    [108] - Safety analysis set
    [109] - Safety analysis set
    No statistical analyses for this end point

    Secondary: Electrocardiogram (ECG) Findings Shift From Baseline to Overall

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    End point title
    		 Electrocardiogram (ECG) Findings Shift From Baseline to Overall
    End point description
    Resting 12-lead ECG were taken at baseline and Day 25 or early withdrawal. The worst post baseline finding for each patient is summarized. Shifts are read as: Baseline / Overall
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1), Day 25 or early withdrawal
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [110]
    13 [111]
    13 [112]
    Units: patients
        Normal / Normal
    7
    8
    9
        Normal / Abnormal
    2
    2
    1
        Abnornal / Normal
    1
    1
    1
        Abnornal / Abnormal
    4
    1
    2
    Notes
    [110] - Safety analysis set
    [111] - Safety analysis set One patient did not have both a baseline and post baseline ECG
    [112] - Safety analysis set
    No statistical analyses for this end point

    Secondary: Patients with Post Baseline Changes in Body Weight or Body Temperature

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    End point title
    		 Patients with Post Baseline Changes in Body Weight or Body Temperature
    End point description
    Patients with post baseline changes in body weight or body temperature are counted.
    End point type
    Secondary
    End point timeframe
    Days 1 - 25
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [113]
    13 [114]
    13 [115]
    Units: patients
    0
    0
    0
    Notes
    [113] - Safety analysis set
    [114] - Safety analysis set
    [115] - Safety analysis set
    No statistical analyses for this end point

    Secondary: Patients with Post Baseline Abnormal Skin Evaluations

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    End point title
    		 Patients with Post Baseline Abnormal Skin Evaluations
    End point description
    Special attention was paid to skin rashes or hypersensitivity reactions.
    End point type
    Secondary
    End point timeframe
    Day 1 – Day 35
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [116]
    13 [117]
    13 [118]
    Units: patients
    1
    0
    2
    Notes
    [116] - Safety analysis set
    [117] - Safety analysis set
    [118] - Safety analysis set
    No statistical analyses for this end point

    Secondary: Patients with Post Baseline Suicidal Ideation as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS) Scale for Children

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    End point title
    		 Patients with Post Baseline Suicidal Ideation as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS) Scale for Children
    End point description
    The C-SSRS-Children’s Since Last Visit version was used post baseline at day 1 discharge from the study center, each weekly outpatient visit on days 11 and 18, check-in to the study center on day 24, at the final assessment (or early withdrawal), and at the follow-up visit (approximately day 32). Any abnormal finding is summarized.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 35
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [119]
    13 [120]
    13 [121]
    Units: patients
    0
    0
    0
    Notes
    [119] - Safety analysis set
    [120] - Safety analysis set
    [121] - Safety analysis set
    No statistical analyses for this end point

    Secondary: Change from Baseline after a Single Dose (Day 1) and after Multiple Doses (Day 25) in Multiple Sleep Latency Test (MSLT)

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    End point title
    		 Change from Baseline after a Single Dose (Day 1) and after Multiple Doses (Day 25) in Multiple Sleep Latency Test (MSLT)
    End point description
    The MSLT is an objective assessment of sleepiness that measures the likelihood of falling asleep (Carskadon et al 1986). The test consists of five 20-minute naps performed at 1000, 1200, 1400, 1600, and 1800. Every effort should have been made to perform each MSLT assessment at the specified time relative to dose administration. The date and time of MSLT assessment were reflected on the case report form. MSLT was performed on the day before study drug administration (day -1), on the day of study drug administration on days 1 and 25. No napping was permitted between MSLT naps. For each nap, sleep latency was measured as the elapsed time from lights-out to the first epoch scored as sleep. MSLT tracings from all centers were sent to an independent evaluator to be scored. Mean sleep latency was the average of the sleep latencies from the 5 naps performed at each time point. Positive change from baseline scores indicate longer periods of wakefulness.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1), Days 1 and 25
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [122]
    13 [123]
    13 [124]
    Units: minutes
    arithmetic mean (standard deviation)
        Single Dose (Day 1)
    1.9 ( 3.69 )
    4.3 ( 5.02 )
    4.9 ( 5.82 )
        Multiple Doses (Day 25)
    2.1 ( 4.81 )
    2.1 ( 3.14 )
    2.3 ( 6.4 )
    Notes
    [122] - Pharmacodynamic analysis set Day 1: n=14 Day 25: n=12
    [123] - Pharmacodynamic analysis set Day 1: n=13 Day 25: n=12
    [124] - Pharmacodynamic analysis set Day 1: n=13 Day 25: n=10
    No statistical analyses for this end point

    Secondary: Clinical Global Impression of Change (GCI-C) of Excessive Sleepiness after a Single Dose (Day 1) and after Multiple Doses (Day 25)

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    End point title
    		 Clinical Global Impression of Change (GCI-C) of Excessive Sleepiness after a Single Dose (Day 1) and after Multiple Doses (Day 25)
    End point description
    The CGI–C is an assessment by the investigator of change in the patient’s severity of excessive sleepiness (ES) during the course of the study. The scale has been used in child/adolescent studies with modafinil, is easily administered, and provides useful information regarding clinical benefit. At each time point, the physician (or another qualified clinician, if other than the physician) asked the parent or legal guardian to assess the child’s home behavior over the past week. If possible, the rater and the parent/legal guardian respondent should have remained consistent for each child for the duration of the study. The CGI-C ratings were assessed using the following 7 categories and scoring assignments:  1=very much improved 2=much improved  3=minimally improved  4=no change  5=minimally worse  6=much worse  7=very much worse
    End point type
    Secondary
    End point timeframe
    Day 1 and 25
    End point values
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Number of subjects analysed
    14 [125]
    13 [126]
    13 [127]
    Units: patients
        Day 1: Very much improved
    1
    0
    1
        Day 1: Much improved
    4
    7
    6
        Day 1: Minimally improved
    4
    4
    5
        Day 1: No change
    5
    2
    1
        Day 1: Minimally worse
    0
    0
    0
        Day 1: Much worse
    0
    0
    0
        Day 1: Very much worse
    0
    0
    0
        Day 1: Not assessed
    0
    0
    0
        Day 25: Very much improved
    0
    0
    2
        Day 25: Much improved
    5
    7
    6
        Day 25: Minimally improved
    3
    3
    1
        Day 25: No change
    2
    2
    1
        Day 25: Minimally worse
    2
    0
    0
        Day 25: Much worse
    0
    0
    0
        Day 25: Very much worse
    0
    0
    0
        Day 25: Not assessed
    0
    0
    0
    Notes
    [125] - Pharmacodynamic analysis set Day 1: n=14 Day 25: n=12
    [126] - Pharmacodynamic analysis set Day 1: n=13 Day 25: n=12
    [127] - Pharmacodynamic analysis set Day 1: n=13 Day 25: n=10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 up to Day 35
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Armodafinil 50 mg
    Reporting group description
    		 Patients received a single 50 mg dose of armodafinil on day 1. No intervention was administered on days 2+3. Patients received a single 50 mg daily dose of armodafinil on days 4-25. All doses of armodafinil must have been taken intact with up to 240 mL of water and the entire dose must have been consumed within 5 minutes.

    Reporting group title
    Armodafinil 100 mg
    Reporting group description
    		 Patients received a single 50 mg dose of armodafinil on day 1. No intervention was administered on days 2+3. Patients received a single 50 mg dose on day 4 then daily 100 mg doses on days 5 - 25. All doses of armodafinil must have been taken intact with up to 240 mL of water and the entire dose must have been consumed within 5 minutes.

    Reporting group title
    Armodafinil 150 mg
    Reporting group description
    		 Patients received a single 50 mg dose of armodafinil on day 1. No intervention was administered on days 2+3. Patients received a single 50 mg dose on day 4, 100 mg doses on days 5 and 6, then daily 150 mg doses on days 7 through 25. All doses of armodafinil must have been taken intact with up to 240 mL of water and the entire dose must have been consumed within 5 minutes.

    Serious adverse events
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Armodafinil 50 mg Armodafinil 100 mg Armodafinil 150 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 14 (64.29%)
    4 / 13 (30.77%)
    9 / 13 (69.23%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 13 (15.38%)
    0 / 13 (0.00%)
         occurrences all number
    0
    2
    0
    Pyrexia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    1
    Chest pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Feeling jittery
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    2
    Vessel puncture site pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    2
    Irritability
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    0
    Hunger
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Sneezing
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Cough
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    2
    0
    Upper respiratory tract congestion
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Epistaxis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Middle insomnia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Depression
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Agitation
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Nightmare
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Intermittent explosive disorder
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Emotional disorder
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Aggression
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Blood pressure systolic increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Electrocardiogram Q wave abnormal
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Subcutaneous haematoma
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Excoriation
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Contusion
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Fall
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Foreign body
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Palpitations
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 14 (21.43%)
    1 / 13 (7.69%)
    4 / 13 (30.77%)
         occurrences all number
    7
    2
    8
    Somnolence
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    0
    1
    Lethargy
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Disturbance in attention
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Ear pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 13 (7.69%)
    2 / 13 (15.38%)
         occurrences all number
    1
    1
    3
    Abdominal pain upper
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    2
    2
    0
    Vomiting
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    1
    Gingival pruritus
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Dry mouth
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Tongue pruritus
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Constipation
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Toothache
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Ingrowing nail
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Ecchymosis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Dermatitis contact
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Acne
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle twitching
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Herpes simplex
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 13 (15.38%)
    1 / 13 (7.69%)
         occurrences all number
    0
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 May 2012
    Amendment 1 (dated 22 May 2012) to the protocol was issued before any patients were enrolled into the study. The primary reason for this amendment was to add a blood sample for measurement of hemoglobin obtained at the week 5 visit during period 2.
    07 Nov 2012
    Amendment 2 (dated 07 November 2012) to the protocol was issued after 1 patient was enrolled into the study. Changes to the protocol were considered to have no negative impact on the safety of the patient already enrolled into the study. The primary reason for this amendment was to add a pregnancy test and C-SSRS assessment at the follow-up visit. Criteria for the need for pregnancy testing were also modified and pharmacokinetic sampling added at each period 2 outpatient visit.
    24 Apr 2013
    Amendment 3 (dated 24 April 2013) to the protocol was issued after 3 patients were enrolled into the study. Changes to the protocol were considered to have no negative impact on the safety of patients already enrolled into the study. The primary reason for this amendment was to revise the overall study design from 2 periods to 1 while accommodating both single- and multiple-dose treatments.

    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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