Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    RTG113388, a Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects with Partial Onset Seizures (≥12 years old) and Subjects with Lennox-Gastaut Syndrome (≥12 years old)

    Summary
    EudraCT number
    		 2010-020154-33
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 Jun 2013

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RTG113388
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000116-PIP01-07
    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
    28 Feb 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jun 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety and tolerability of retigabine/ezogabine as adjunctive treatment in subjects with either partial onset seizures (12 to <18 years old) or Lennox-Gastaut Syndrome (12 to <30 years old) who have participated in a previous (“parent”) study.
    Protection of trial subjects
    Subjects had standard safety testing, i.e. clinical laboratory tests, vital signs, physical examinations, and assessment of sexual maturation. To monitor for the known retigabine/ezogabine pharmacologic effects, baseline and period testing post-void residual ultrasound (urinary retention) and electrocardiogram (ECG) (QT prolongation) were required. Weight-based dosing was implemented to ensure the exposure to retigabine/ezogabine was similar to that deemed acceptable in adults. The suicidality risk with anti-epileptic drugs was assessed using the Columbia Suicide Severity Rating Scale (CSSR-S). Subject study visits were to be at a similar frequency as standard care. To reduce the burden of blood sampling procedure in a population aged < 18 years, blood samples for PK analysis of retigabine/ezogabine were only taken at clinic visits concomitantly with clinical laboratory samples.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Sep 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 4
    Worldwide total number of subjects
    4
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    4
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants (par.) aged 12 years or older, who had participated in a previous parent study GSK113284 (NCT014945840) evaluating Retigabine/Ezogabine in the treatment of partial onset seizures or seizures comprising Lennox-Gastaut syndrome, were enrolled in this open-label extension study.

    Pre-assignment
    Screening details
    		 Eligible par. began the Treatment Period at the eligibility assessment Visit followed by a 3-week Taper Phase, and a Follow-Up Visit within 3 days from the end of the Taper Phase. The study was prematurely discontinued after enrolling only 4 of the planned 500 par.

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

    Arms
    Arm title
    		 Retigabine/Ezogabine TID
    Arm description
    		 Participants (par.) received retigabine/ezogabine as immediate release (IR) tablets three times a day (TID) as add-on therapy. Six dose strengths (25 milligrams(mg)/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg per day (mg/day) (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
    Arm type
    		 Experimental

    Investigational medicinal product name
    retigabine/ezogabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    retigabine/ezogabine as immediate release (IR) tablets three times a day (TID) as add-on therapy. Six dose strengths (25 milligrams (mg)/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg per day (mg/day) (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.

    Number of subjects in period 1
    		Retigabine/Ezogabine TID
    Started
    4
    Completed
    0
    Not completed
    4
         Consent withdrawn by subject
    1
         Study Closed/Terminated
    3

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Retigabine/Ezogabine TID
    Reporting group description
    		 Participants (par.) received retigabine/ezogabine as immediate release (IR) tablets three times a day (TID) as add-on therapy. Six dose strengths (25 milligrams(mg)/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg per day (mg/day) (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.

    Reporting group values
    		 Retigabine/Ezogabine TID Total
    Number of subjects
    		 4 4
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 15.3 ( 1.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 3 3
    Race, Customized
    Units: Subjects
        White/Caucasian/European Heritage
    		 4 4

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Retigabine/Ezogabine TID
    Reporting group description
    		 Participants (par.) received retigabine/ezogabine as immediate release (IR) tablets three times a day (TID) as add-on therapy. Six dose strengths (25 milligrams(mg)/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg per day (mg/day) (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.

    Primary: Number of participants (par.) with any adverse event (AE) or serious adverse event (SAE) during the treatment period

    		 Close Top of page
    End point title
    		 Number of participants (par.) with any adverse event (AE) or serious adverse event (SAE) during the treatment period [1]
    End point description
    An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Please refer to the AE/SAE module for a list of non-serious AEs and SAE.
    End point type
    Primary
    End point timeframe
    From the start of study medication until the end of Follow-Up (up to 178 days)
    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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    4 [2]
    Units: Participants
        Any AE
    4
        Any SAE
    0
    Notes
    [2] - All Subjects Population: all participants who enrolled in the study.
    No statistical analyses for this end point

    Primary: Number of participants with AEs leading to withdrawal

    		 Close Top of page
    End point title
    		 Number of participants with AEs leading to withdrawal [3]
    End point description
    An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Please refer to the AE/SAE module for a list of non-serious AEs and SAE.
    End point type
    Primary
    End point timeframe
    From the start of study medication until the end of the Follow-Up Visit (up to 178 days)
    Notes
    [3] - 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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    4 [4]
    Units: Participants
    0
    Notes
    [4] - All Subjects Population
    No statistical analyses for this end point

    Primary: Number of participants with vital signs outside the pre-determined clinically important findings or outside the normal ranges at any time during the study

    		 Close Top of page
    End point title
    		 Number of participants with vital signs outside the pre-determined clinically important findings or outside the normal ranges at any time during the study [5]
    End point description
    Vital sign assessment included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and body temperature measurements. SBP, DBP and heart rate were measured at the following Visits: 1, 4, 5, 6, 7, EW and the FU Visit after the participants were in the seated position for 5 minutes.
    End point type
    Primary
    End point timeframe
    Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    4 [6]
    Units: Participants
    0
    Notes
    [6] - All Subjects Population
    No statistical analyses for this end point

    Primary: Change from Baseline in SBP and DBP at the indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in SBP and DBP at the indicated time points [7]
    End point description
    Vital sign assessment included SBP and DBP measurements. SBP and DBP were measured at the following Visits: 1, 4, 5, 6, 7, EW, and the FU Visit after the participant was in seated position for 5 minutes. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    Notes
    [7] - 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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [8]
    Units: Millimeters of mercury (mmHg)
        arithmetic mean (standard deviation)
    ( )
    Notes
    [8] - All Subjects Population
    No statistical analyses for this end point

    Primary: Change from Baseline in heart rate at the indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in heart rate at the indicated time points [9]
    End point description
    Vital sign assessment included heart rate measured at the following Visits: 1, 4, 5, 6, 7, EW, and the FU Visit after the participant was in seated position for 5 minutes. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [10]
    Units: Beats per minute (bpm)
        arithmetic mean (standard deviation)
    ( )
    Notes
    [10] - All Subjects Population
    No statistical analyses for this end point

    Primary: Change from Baseline in body temperature at the indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in body temperature at the indicated time points [11]
    End point description
    Vital sign assessment included body temperature measurements at the following Visits: 1, 4, 5, 6, 7, EW, and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    Notes
    [11] - 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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [12]
    Units: Celsius
        arithmetic mean (standard deviation)
    ( )
    Notes
    [12] - All Subjects Population
    No statistical analyses for this end point

    Primary: Change from Baseline in body height at indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in body height at indicated time points [13]
    End point description
    Body height was measured without shoes and wearing light clothing at the following Visits: 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [14]
    Units: Centimeter (cm)
        arithmetic mean (standard deviation)
    ( )
    Notes
    [14] - All Subjects Population
    No statistical analyses for this end point

    Primary: Change from Baseline in body weight at the indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in body weight at the indicated time points [15]
    End point description
    Body weight was measured without shoes and wearing light clothing at the following Visits: 1, 4, 5, 6, 7, EW and FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    Notes
    [15] - 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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [16]
    Units: Kilogram (kg)
        arithmetic mean (standard deviation)
    ( )
    Notes
    [16] - All Subjects Population
    No statistical analyses for this end point

    Primary: Change from Baseline in body mass index (BMI) at the indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in body mass index (BMI) at the indicated time points [17]
    End point description
    BMI is calculated as weight in kilograms (kg) divided by the square of their height in metres (m^2). BMI was measured at the following Visits: 1, 4, 5, 6, 7, EW and FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [18]
    Units: kilogram per meter square (kg/m^2)
        arithmetic mean (standard deviation)
    ( )
    Notes
    [18] - All Subjects Population
    No statistical analyses for this end point

    Primary: Change from Baseline in electrocardiogram (ECG) at the indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in electrocardiogram (ECG) at the indicated time points [19]
    End point description
    The 12-lead ECG was recorded in a supine position at the Eligibility Assessment Visitand the EW Visit after having kept a participant at rest in this position for 10 minutes. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), EW Visit (up to 178 days)
    Notes
    [19] - 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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [20]
    Units: Milliseconds
        arithmetic mean (standard deviation)
    ( )
    Notes
    [20] - All Subjects Population
    No statistical analyses for this end point

    Primary: Number of participants with abnormal clinically significant ECG findings based on investigator judgment at anytime during the study

    		 Close Top of page
    End point title
    		 Number of participants with abnormal clinically significant ECG findings based on investigator judgment at anytime during the study [21]
    End point description
    The 12-lead ECG was recorded in a supine position at the Eligibility Assessment Visit andthe EW Visit after having kept a participant at rest in this position for 10 minutes. Abnormal findings were analyzed as clinically significant (CS) and not clinically significant (NCS). The study investigator judged the ECG abnormailities as CS or NCS.
    End point type
    Primary
    End point timeframe
    Eligibility Assessment and EW Visit
    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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    4 [22]
    Units: Participants
    0
    Notes
    [22] - All Subjects Population
    No statistical analyses for this end point

    Primary: Change from Baseline in ALT, ALP, AST, CK, and LDH measurements at the indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in ALT, ALP, AST, CK, and LDH measurements at the indicated time points [23]
    End point description
    Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Alanine amino transferase (ALT), alkaline phosphotase (ALP), aspartate amino transferase (AST), creatine kinase (CK), and lactate dehydrogenase (LDH) parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    Notes
    [23] - 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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [24]
    Units: International units per liter (IU/L)
        arithmetic mean (standard deviation)
    ( )
    Notes
    [24] - All Subjects Population
    No statistical analyses for this end point

    Primary: Change from Baseline in albumin, total protein, hemoglobin, and mean corpuscle hemoglobin measurements at the indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in albumin, total protein, hemoglobin, and mean corpuscle hemoglobin measurements at the indicated time points [25]
    End point description
    Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Albumin, total protein, hemoglobin, and mean corpuscle hemoglobin concentration parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [26]
    Units: Grams per Liter (G/L)
        arithmetic mean (standard deviation)
    ( )
    Notes
    [26] - All Subjects Population
    No statistical analyses for this end point

    Primary: Change from Baseline in the BUN/Creatinine and the Urine Albumin/Creatinine Ratios at the indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in the BUN/Creatinine and the Urine Albumin/Creatinine Ratios at the indicated time points [27]
    End point description
    Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Blood Urea Nitrogen (BUN)/Creatinine and Urine Albumin/Creatinine were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    Notes
    [27] - 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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [28]
    Units: Ratio
        arithmetic mean (standard deviation)
    ( )
    Notes
    [28] - All Subjects Population
    No statistical analyses for this end point

    Primary: Change from Baseline in calcium, carbon dioxide content/bicarbonate, chloride, cholesterol, glucose, magnesium, inorganic phosphorus, potassium, sodium, and urea/BUN measurements at the indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in calcium, carbon dioxide content/bicarbonate, chloride, cholesterol, glucose, magnesium, inorganic phosphorus, potassium, sodium, and urea/BUN measurements at the indicated time points [29]
    End point description
    Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Calcium, carbon dioxide content/bicarbonate, chloride, cholesterol, glucose, magnesium, inorganic phosphorus, potassium, sodium, and urea/BUN parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [30]
    Units: Millimole per liter (MMOL/L)
        arithmetic mean (standard deviation)
    ( )
    Notes
    [30] - All Subjects Population
    No statistical analyses for this end point

    Primary: Change from Baseline in creatinine, direct bilirubin, indirect bilirubin, total bilirubin, uric acid, and urine creatinine concentration measurements at the indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in creatinine, direct bilirubin, indirect bilirubin, total bilirubin, uric acid, and urine creatinine concentration measurements at the indicated time points [31]
    End point description
    Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Creatinine, direct bilirubin, indirect bilirubin, total bilirubin, uric acid, and urine creatinine concentration parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    Notes
    [31] - 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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [32]
    Units: Micromole per liter (UMOL/L)
        arithmetic mean (standard deviation)
    ( )
    Notes
    [32] - All Subjects Population
    No statistical analyses for this end point

    Primary: Change from Baseline in Thyroid Stimulating Hormone (TSH) and Urine Albumin measurements at the indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in Thyroid Stimulating Hormone (TSH) and Urine Albumin measurements at the indicated time points [33]
    End point description
    Clinical laboratory assessments included measurements of endocrine and urinalysis parameters. TSH and urine albumin parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [34]
    Units: Milliunits per liter (MU/L)
        arithmetic mean (standard deviation)
    ( )
    Notes
    [34] - All Subjects Population
    No statistical analyses for this end point

    Primary: Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils, and white blood cell count measurements at the indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils, and white blood cell count measurements at the indicated time points [35]
    End point description
    Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils (Total absolute neutrophil count- total ANC), and white blood cell count parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    Notes
    [35] - 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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [36]
    Units: Giga (10^9) per liter (GI/L)
        arithmetic mean (standard deviation)
    ( )
    Notes
    [36] - All Subjects Population
    No statistical analyses for this end point

    Primary: Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils, and red cell distribution width (RDW) percentages at the indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils, and red cell distribution width (RDW) percentages at the indicated time points [37]
    End point description
    Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils, total neutrophils and red cell distribution width (RDW) parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [38]
    Units: percentage (%)
        arithmetic mean (standard deviation)
    ( )
    Notes
    [38] - All Subjects Population
    No statistical analyses for this end point

    Primary: Change from Baseline in the hematocrit measurements at the indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in the hematocrit measurements at the indicated time points [39]
    End point description
    Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Hematocrit was measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    Notes
    [39] - 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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [40]
    Units: one unit
        arithmetic mean (standard deviation)
    ( )
    Notes
    [40] - All Subjects Population
    No statistical analyses for this end point

    Primary: Change from Baseline in the mean corpuscle volume and mean platelet volume measurements at the indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in the mean corpuscle volume and mean platelet volume measurements at the indicated time points [41]
    End point description
    Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Mean corpuscle volume and mean platelet colume parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [42]
    Units: femtoliters (FL)
        arithmetic mean (standard deviation)
    ( )
    Notes
    [42] - All Subjects Population
    No statistical analyses for this end point

    Primary: Change from Baseline in mean corpuscle hemoglobin at the indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in mean corpuscle hemoglobin at the indicated time points [43]
    End point description
    Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Mean corpuscle hemoglobin was measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    Notes
    [43] - 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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [44]
    Units: picograms (PG)
        arithmetic mean (standard deviation)
    ( )
    Notes
    [44] - All Subjects Population
    No statistical analyses for this end point

    Primary: Change from Baseline in the red blood cell count measurements at the indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in the red blood cell count measurements at the indicated time points [45]
    End point description
    Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. The red blood cell count was measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [46]
    Units: 10^12
        arithmetic mean (standard deviation)
    ( )
    Notes
    [46] - All Subjects Population
    No statistical analyses for this end point

    Primary: Number of participants with hematology, chemistry and urinalysis parameters outside the normal ranges and pre-determined clinically important ranges

    		 Close Top of page
    End point title
    		 Number of participants with hematology, chemistry and urinalysis parameters outside the normal ranges and pre-determined clinically important ranges [47]
    End point description
    Clinical laboratory assessment included hematology, chemistry and urinalysis parameters. Clinical laboratory parameters were measured at Visit 1, 4, 5, 6, 7, EW and FU Visit. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)
    Notes
    [47] - 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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [48]
    Units: Participants
    Notes
    [48] - All Subjects Population
    No statistical analyses for this end point

    Primary: Changes from Baseline in bladder volume as assessed by the post void residual (PVR) ultrasound at the indicated time points

    		 Close Top of page
    End point title
    		 Changes from Baseline in bladder volume as assessed by the post void residual (PVR) ultrasound at the indicated time points [49]
    End point description
    The PVR urine test measured the amount of urine left in the bladder after urination. The PVR bladder ultrasound was performed by an urologist, a qualified technician or by an appropriately trained qualified study nurse at Visits 1, 6, and the EW Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1), Visit 6, EW Visit
    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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [50]
    Units: Milliliter
        arithmetic mean (standard deviation)
    ( )
    Notes
    [50] - All Subjects Population
    No statistical analyses for this end point

    Primary: Changes from Baseline in cognition as measured by the Leiter-R at the indicated time points

    		 Close Top of page
    End point title
    		 Changes from Baseline in cognition as measured by the Leiter-R at the indicated time points [51]
    End point description
    The Leiter International Performance Scale or simply Leiter is an intelligence test for children and adolescents, with norms ranging from 2 to 20 years. For all ages, it yields an intelligence quotient (IQ) and a measure of logical ability. It is comprised of ten subtests, seven of which were relevant to the 12-18 years age group. The administration time was approximately 40 minutes. During the study, only the parent/caregiver completed this questionnaire while the participants were within the age range (i.e. <20 years). Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). The parent study did not measure baseline cognition, behavior, and learning so changes from baseline were not available for participants in this study.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1) up to 178 days
    Notes
    [51] - 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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [52]
    Units: Scores on scale
        number (not applicable)
    Notes
    [52] - All Subjects Population
    No statistical analyses for this end point

    Primary: Changes from Baseline in behaviour as measured by the child behavior checklist (CBCL) at the indicated time points

    		 Close Top of page
    End point title
    		 Changes from Baseline in behaviour as measured by the child behavior checklist (CBCL) at the indicated time points [53]
    End point description
    The CBCL is a widely used parent report questionnaire identifying behavioural and emotional problems in children. The checklist is comprised of a number of statements about the child's behavior, e.g. acts too young for his/her age. Responses were recorded on a likert scale: 0 = not true, 1 = somewhat or sometimes true, 2 = very true or often true. The preschool checklist contained 100 questions and the school-age checklist contained 120 questions. During the study, only the parent/caregiver completed this questionnaire while the participants were within the age range (i.e. <18 years). Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). The parent study did not measure baseline cognition, behavior, and learning so changes from baseline were not available for participants in this study.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1) up to 178 days
    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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [54]
    Units: Scores on scale
        number (not applicable)
    Notes
    [54] - All Subjects Population
    No statistical analyses for this end point

    Primary: Changes from Baseline in learning as measured by the wide range assessment of memory and learning , 2nd edition (WRAML2) at the indicated time points

    		 Close Top of page
    End point title
    		 Changes from Baseline in learning as measured by the wide range assessment of memory and learning , 2nd edition (WRAML2) at the indicated time points [55]
    End point description
    The WRAML2 is a standardized test that measures an individual’s memory functioning. It evaluates both visual and verbal, immediate and delayed memory ability along with the acquisition of new learning. The WRAML2 core battery is composed of two verbal, two visual, and two attention concentration subtests, yielding a verbal memory index, a visual memory index and an attention-concentration index. Together, these tests yield the general memory index. The administration time is approximately 40 minutes. During the study, this test was administered if the participant was within the age range (i.e. >9 years). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). The parent study did not measure Baseline cognition, behavior, and learning so changes from Baseline were not available for participants in this study.
    End point type
    Primary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1) up to 178 days
    Notes
    [55] - 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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [56]
    Units: Scores on scale
        number (not applicable)
    Notes
    [56] - All Subjects Population
    No statistical analyses for this end point

    Primary: Number of participants with sexual maturation based on the Tanner Stage I to Stage V of Puberty in participants <=18 years old throughout the study

    		 Close Top of page
    End point title
    		 Number of participants with sexual maturation based on the Tanner Stage I to Stage V of Puberty in participants <=18 years old throughout the study [57]
    End point description
    The number of participants who advanced a stage between the eligibility visit and the EW Visit was recorded. Tanner stage I is defined as no pubic hair at all (prepubertal Dominic state); stage II is defined as a small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum (males) or on the labia majora (females); stage III is defined as when the hair becomes more coarse and curly, and begins to extend laterally; stage IV is defined as adult-like hair quality, extending across pubis but sparing medial thighs; and stage V is defined as when the: hair extends to medial surface of the thighs. The investigator assessed the participant's sexual development in participants <18 years old based on the Tanner Stages of Puberty.
    End point type
    Primary
    End point timeframe
    Eligibility Assessment (Visit 1) and EW Visit
    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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    4 [58]
    Units: Participants
        Stage I to Stage II
    0
        Stage II to Stage III
    0
        Stage III to Stage IV
    0
        Stage IV to Stage V
    2
        Stage V
    2
    Notes
    [58] - All Subjects Population
    No statistical analyses for this end point

    Primary: Number of days of exposure to Retigabine/Ezogabine TID by individual participant

    		 Close Top of page
    End point title
    		 Number of days of exposure to Retigabine/Ezogabine TID by individual participant [59]
    End point description
    Total number of days each participant was exposed to Retigabine/Ezogabine are recorded here.
    End point type
    Primary
    End point timeframe
    Treatment Phase plus Taper Phase (up to 97 days)
    Notes
    [59] - 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 statistical analysis was conducted; thus, there are no statistical data to report
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    4 [60]
    Units: Days
        Participant 1
    133
        Participant 2
    213
        Participant 3
    196
        Participant 4
    166
    Notes
    [60] - All Subjects Population
    No statistical analyses for this end point

    Secondary: Percent change from Baseline in the seizure frequency at the indicated time points

    		 Close Top of page
    End point title
    		 Percent change from Baseline in the seizure frequency at the indicated time points
    End point description
    The percentage reduction from Baseline in the seizure frequency was summarized using descriptive statistics. The frequencies and percentages were computed for a reduction in seizure frequency of >50% as well as for a 100% reduction (seizure-free). Increases of >50% in seizure frequency was also summarized. The percentage of seizure-free days wasere also analyzed. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1) up to 178 days
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [61]
    Units: Percentage of seizure frequency
        arithmetic mean (standard deviation)
    ( )
    Notes
    [61] - All Subjects Population
    No statistical analyses for this end point

    Secondary: Number of participants who were responders during the treatment period

    		 Close Top of page
    End point title
    		 Number of participants who were responders during the treatment period
    End point description
    A ''responder'' is defined as >50% reduction from Baseline in the seizure frequency. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Eligibility Assessment (Visit 1) up to 178 days
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [62]
    Units: Participants
    Notes
    [62] - All Subjects Population
    No statistical analyses for this end point

    Secondary: Clinical Global Impression- Improvement (CGI-I) Assessment at the indicated time points

    		 Close Top of page
    End point title
    		 Clinical Global Impression- Improvement (CGI-I) Assessment at the indicated time points
    End point description
    The Clinical Global Impression (CGI) scale provided an overall clinician-determined summary measure. It had 2 components: the CGI-Severity of Illness (CGI-S) scale and the CGI- Improvement (CGI-I) scale which rated the change from Baseline. The CGI-I scale scores range from 0 to 7 and are interpreted as 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1) up to 178 days
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [63]
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    ( )
    Notes
    [63] - All Subjects Population
    No statistical analyses for this end point

    Secondary: Clinical Global Impression-Severity of illness (CGI-S) assessment at the indicated time points

    		 Close Top of page
    End point title
    		 Clinical Global Impression-Severity of illness (CGI-S) assessment at the indicated time points
    End point description
    The Clinical Global Impression (CGI) scale provided an overall clinician-determined summary measure. It had 2 components: the CGI-Severity of Illness (CGI-S) scale and the CGI-Improvement (CGI-I) scale which rated the change from Baseline. The CGI-S was a 7-point scale that required the investigator to rate the severity of the participant’s epilepsy relative to the investigator’s past experience with other participants with the same diagnosis. The CGI-S scale scores range from 0 to 7 and are interpreted as 0=not assessed, 1=normal, 2=borderline, 3=mild, 4=moderate, 5=marked, 6=severe, 7=extremely severe. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Baseline, Eligibility Assessment (Visit 1) up to 178 days
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [64]
    Units: Scores on scale
        arithmetic mean (standard deviation)
    ( )
    Notes
    [64] - All Subjects Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in child health status as measured by the child health questionnaire (CHQ) in participants <18 years old at the indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in child health status as measured by the child health questionnaire (CHQ) in participants <18 years old at the indicated time points
    End point description
    The CHQ comprises scales specifically developed for children and adolescents aged five years and older. The CHQ assesses a child's physical, emotional, and social well-being from the perspective of a parent or guardian. The questionnaire was completed by a parent/caregiver and administration time was approximately 30 minutes. The parent/caregiver completed this questionnaire while the participant was within the age range (i.e. <18 years). Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Baseline, Eligibilty Assessment (Visit 1), EW Visit and FU Visit (up to 178 days)
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [65]
    Units: Scores on scale
        arithmetic mean (standard deviation)
    ( )
    Notes
    [65] - All Subjects Population
    No statistical analyses for this end point

    Secondary: Area under the plasma concentration-time curve (AUC) following oral administration of Retigabine/ezogabine at the indicated time points

    		 Close Top of page
    End point title
    		 Area under the plasma concentration-time curve (AUC) following oral administration of Retigabine/ezogabine at the indicated time points
    End point description
    AUC is defined as the area under the plasma drug concentration-time curve, reflects the actual body exposure to drug after administration of a dose of the drug and is expressed in milligram*hour per Liter (mg*h/L). Blood samples for population PK analysis of retigabine/ezogabine were taken at clinic visits where routine clinical laboratory samples were also taken. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Eligibility Assessment (Visit 1) up to 178 days
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [66]
    Units: mg*h/L
        geometric mean (confidence interval 95%)
    ( to )
    Notes
    [66] - All Subjects Population
    No statistical analyses for this end point

    Secondary: Apparent clearance (CL/F) following oral administration of Retigabine/ezogabine at indicated time points

    		 Close Top of page
    End point title
    		 Apparent clearance (CL/F) following oral administration of Retigabine/ezogabine at indicated time points
    End point description
    Blood samples for population pharmacokinetic analysis of retigabine/ezogabine were taken at clinic visits where routine clinical laboratory samples were also taken. CL/F, where CL is the calculated as dose/AUC and F is the oral bioavailability of the drug. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled
    End point type
    Secondary
    End point timeframe
    Eligibility Assessment (Visit 1) up to 178 days
    End point values
    		 Retigabine/Ezogabine TID
    Number of subjects analysed
    0 [67]
    Units: Milliliters per hour (mL/hr)
        geometric mean (confidence interval 95%)
    ( to )
    Notes
    [67] - All Subjects Population
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Non-serious adverse event (AE) and serious adverse events (SAE) were collected from the start of study treatment until the Follow-Up contact (Up to 178 days)
    Adverse event reporting additional description
    SAEs and non-serious AEs are reported for members of the Safety Population, comprised of participants who took at least one dose of investigational product after being enrolled into the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Retigabine/ezogabine TID
    Reporting group description
    		 Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability) over the course of this long-term open-label extension study. Physicians used their clinical judgment in making dose adjustments. Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.

    Serious adverse events
    		 Retigabine/ezogabine TID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Retigabine/ezogabine TID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Ingrowing nail
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Infections and infestations
    Viral infection
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Aug 2011
    Amendment No.01: The amendment updates the Sponsor Information, removes the Transition Phase, clarifies the population, updates the Study Design (assessments, visit schedules, definitions, and endpoints), adds the maximum daily dose, and updates the statistical section.
    02 Dec 2011
    Amendment No. 02: The amendment clarifies the differences in maximum daily dose by age, removes the expedited reporting requirement for neutrophil counts, all discontinuations due to hematological reasons/infections and all serious hematological events/infections, and includes additional assessments during Year 2 and beyond.

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

    European Medicines Agency © 1995-Thu Apr 25 15:36:35 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA