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    Clinical Trial Results:
    A single blind study comparing the efficacy of Glycopyrronium and Hyoscine on drooling in children with neurodisability - DRI Trial (Drooling Reduction Intervention)

    Summary
    EudraCT number
    		 2013-000863-94
    Trial protocol
    		 GB  
    Global end of trial date
    31 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jan 2019
    First version publication date
    05 Jan 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    6474
    Additional study identifiers
    ISRCTN number
    		 ISRCTN75287237
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 REC : 13/NE/0078
    Sponsors
    Sponsor organisation name
    The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Sponsor organisation address
    Regent Point, Regent Farm Road, Newcastle upon Tyne, United Kingdom, NE3 3HD
    Public contact
    Dr Parr, Chief Investigator, Newcastle University, 44 0191 282 5966, jeremy.parr@ncl.ac.uk
    Scientific contact
    Dr Parr, Chief Investigator, Newcastle University, 44 0191 282 5966, jeremy.parr@ncl.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To identify whether Glycopyrronium or Hyoscine is more effective in treating drooling in children with non-progressive disability
    Protection of trial subjects
    The trial involved an independent Data Monitoring Committee (DMC) and Trial Steering Commitee to provide overall supervision for the trial on behalf of the Trial Sponsor and Trial Funder and to safeguard the interests of trial participants, monitor the main outcome measures including safety and efficacy, and monitor the overall conduct of the trial.
    Background therapy
    		 Drooling is due to oromotor impairment, and is a common problem in children with neurodevelopmental disorders. The negative consequences of drooling for children and their relatives include skin breakdown to the child’s chin, dehydration, and damage to clothing and equipment such as electronic communication aids. Children, siblings and parents often suffer social embarrassment due to drooling. There is no evidence about the relative effectiveness of the two medications most commonly used to reduce drooling. There are only limited data about their side effects and how acceptable they are to children and parents; this lack of information makes it difficult for children, parents and doctors to make informed decisions about which drug to use, and at what dose. This study will determine whether there is a difference in the effectiveness of the medications, and which doses are associated with fewest side effects. This information will be used to develop evidence based guidance to help children, parents and doctors firstly to decide which medication to prescribe to reduce problematic drooling and at what dose; secondly to show how adverse effects can be monitored, and when dosage should be reduced or medication stopped. The study will benefit children with neurodisability who drool and their families. By identifying how best to choose medication, decide on dosage and monitor effect and side effects, this applied research study relates to day to day practice of health service staff – specifically paediatricians and speech and language therapists. Children’s drooling will be better controlled with the accompanying physical and psychosocial benefits for child and family.
    Evidence for comparator
    		 Medication is the first intervention used by most UK clinicians and helps many children; both Hyoscine and Glycopyrronium work by reducing cholinergic stimulation of salivary glands, and the volume of saliva produced. There is a lack of research evidence about which of the two most commonly used medications works best, and which is best tolerated. Glycopyrronium is an oral medication (liquid) and hyoscine a skin patch; a double blind trial was therefore not appropriate.. The most effective dose and regime to increase doses is not known. The study involved escalating doses up to a maximum suggested in the British National Formulary for Children. The medication regime: 1. Glycopyrronium study arm Week 1: 40mcg/kg/ per dose Week 2, 60mcg/kg/ per dose Week 3, 80mcg/kg/ per dose Week 4, 100mcg/kg/ per dose All doses three times a day. Adjusted according to response up to maximum 2 mg per dose per day 2. Hyoscine study arm Week one ¼ patch, week two ½ patch, week three ¾ patch, week four full patch The patch will be replaced every three days, alternating sites to minimise the risk of a local skin reaction. The patch will not be cut (this results in loss of absorption), but an occlusive dressing will be used as per usual clinical practice.
    Actual start date of recruitment
    01 Sep 2013
    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 Kingdom: 90
    Worldwide total number of subjects
    90
    EEA total number of subjects
    90
    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)
    85
    Adolescents (12-17 years)
    5
    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
    		 In the course of normal clinical practice, parents/guardians and the local paediatrician would determine if a child needed medication for drooling. If it was the case, the local paediatrician the trial approached the family regarding the child's potential participation in the study.

    Pre-assignment
    Screening details
    		 Recruitment was conducted by the local paediatrician during standard clinical care visit, so that only children who were deemed by the clinician and the family to need treatment for drooling were invited to participate. Parent/Guardian were provided with an Information Sheet and an opportunity to ask any questions about the study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Randomised trial of two medication regimes known to patient and clinician but not the Trial Outcome Assessor.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Glycopyrronium
    Arm description
    		 Children randomised to glycopyrronium liquid received three doses per day: week-1: 40 μg/kg/per dose; week-2: 60 μg/kg/per dose; week-3: 80 μg/kg/ per dose; week-4: 100 μg/kg/per dose to a maximum 2 mg per dose. Medication was given orally or by feeding tube. Please note the number of participants started refers to the number of participants randomised to the trial. Five participants withdrew prior to receiving any treatment on the trial.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Glycopyrronium Bromide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The medication regime for participants randomised to the Glycopyrronium study arm: Week 1: 40mcg/kg/ per dose Week 2, 60mcg/kg/ per dose Week 3, 80mcg/kg/ per dose Week 4, 100mcg/kg/ per dose All doses three times a day. Adjusted according to response up to maximum 2 mg per dose per day. Trial medication continued for 12 weeks after which all trial medication was then returned. At the end of week 12, the Trial Research Paediatrician contacted the parent again to remind them of a pre-arranged appointment with their usual local paediatrician. Their local paediatrician will discussed with the parents whether their child should continue on the same medication (locally prescribed) or use alternative management.

    Arm title
    		 Hyoscine
    Arm description
    		 Children randomised to the hyoscine received the following regime: week-1: ¼ patch; week-2: ½ patch; week-3: ¾ patch; week-4: full patch. The patch was typically placed below an ear with an occlusive dressing applied over and replaced every 3 days, alternating sites to minimise local skin reaction risk. The plastic patch backing was cut to expose the prescribed portion of the patch; the patch itself was not cut to avoid leakage of product from the non-loculated reservoir. Please note the number of participants started refers to the number of participants randomised to the trial. Five participants withdrew prior to receiving any treatment on the trial.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hyoscine
    Investigational medicinal product code
    Other name
    Scopoderm
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    Dosage and administration details
    Transdermal patch containing 1.5mg hyoscine. Hyoscine patches 1mg/72 hours were provided as a 12 week supply of patches; the patch was replaced every three das, alternating sites to minimise the risk of a local skin reaction. Treatment schedule: Week one 1/4 patch, week two 1/2 patch, week three 3/4 patch, week four full patch.

    Number of subjects in period 1
    		Glycopyrronium Hyoscine
    Started
    41
    49
    4 week outcome
    33
    35
    12 week outcome
    31
    26
    Completed
    31
    26
    Not completed
    10
    23
         Not right time to participate in a trial
    -
    1
         Adverse event, non-fatal
    7
    21
         Family Illness
    1
    -
         Concern about side effects
    1
    1
         Drooling no longer a problem
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Glycopyrronium
    Reporting group description
    		 Children randomised to glycopyrronium liquid received three doses per day: week-1: 40 μg/kg/per dose; week-2: 60 μg/kg/per dose; week-3: 80 μg/kg/ per dose; week-4: 100 μg/kg/per dose to a maximum 2 mg per dose. Medication was given orally or by feeding tube. Please note the number of participants started refers to the number of participants randomised to the trial. Five participants withdrew prior to receiving any treatment on the trial.

    Reporting group title
    Hyoscine
    Reporting group description
    		 Children randomised to the hyoscine received the following regime: week-1: ¼ patch; week-2: ½ patch; week-3: ¾ patch; week-4: full patch. The patch was typically placed below an ear with an occlusive dressing applied over and replaced every 3 days, alternating sites to minimise local skin reaction risk. The plastic patch backing was cut to expose the prescribed portion of the patch; the patch itself was not cut to avoid leakage of product from the non-loculated reservoir. Please note the number of participants started refers to the number of participants randomised to the trial. Five participants withdrew prior to receiving any treatment on the trial.

    Reporting group values
    		 Glycopyrronium Hyoscine Total
    Number of subjects
    		 41 49 90
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Ninety children from 15 UK National Health Service (NHS) neurodevelopmental teams recruited over 17 months.
    Units: years
        median (full range (min-max))
    		 4.6 (3.0 to 11.9) 4.9 (3.0 to 14.5) -
    Gender categorical
    Units: Subjects
        Female
    		 19 16 35
        Male
    		 22 33 55
    Severity of drooling
    Units: Subjects
        Saliva usually on clothes
    		 35 43 78
        Saliva usually on face
    		 6 6 12
    Weight
    Units: Kg
        median (full range (min-max))
    		 16.6 (10.4 to 41.8) 18.1 (11.1 to 79.4) -

    End points

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    End points reporting groups
    Reporting group title
    Glycopyrronium
    Reporting group description
    		 Children randomised to glycopyrronium liquid received three doses per day: week-1: 40 μg/kg/per dose; week-2: 60 μg/kg/per dose; week-3: 80 μg/kg/ per dose; week-4: 100 μg/kg/per dose to a maximum 2 mg per dose. Medication was given orally or by feeding tube. Please note the number of participants started refers to the number of participants randomised to the trial. Five participants withdrew prior to receiving any treatment on the trial.

    Reporting group title
    Hyoscine
    Reporting group description
    		 Children randomised to the hyoscine received the following regime: week-1: ¼ patch; week-2: ½ patch; week-3: ¾ patch; week-4: full patch. The patch was typically placed below an ear with an occlusive dressing applied over and replaced every 3 days, alternating sites to minimise local skin reaction risk. The plastic patch backing was cut to expose the prescribed portion of the patch; the patch itself was not cut to avoid leakage of product from the non-loculated reservoir. Please note the number of participants started refers to the number of participants randomised to the trial. Five participants withdrew prior to receiving any treatment on the trial.

    Primary: Drooling Impact Scale (DIS) score at 4 weeks

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    End point title
    		 Drooling Impact Scale (DIS) score at 4 weeks
    End point description
    End point type
    Primary
    End point timeframe
    Drooling Impact Scale (DIS) score at 4 weeks
    End point values
    		 Glycopyrronium Hyoscine
    Number of subjects analysed
    29
    41
    Units: number
        arithmetic mean (standard deviation)
    25.3 ( 14.1 )
    32.1 ( 19.4 )
    Statistical analysis title
    		 Difference in mean scores week 4 DIS Scores
    Comparison groups
    Hyoscine v Glycopyrronium
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 15.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.2

    Primary: Sensitivity analysis of the primary outcome measure: Week 4 DIS Score

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    End point title
    		 Sensitivity analysis of the primary outcome measure: Week 4 DIS Score
    End point description
    The analysis set is the treatment tolerated set. This analysis repeats the analysis of the primary outcome measure, however, rather than an ITT analysis, only those patients who tolerated their treatment and were still on the treatment to which randomised at week 4 are included. Of the 70 patients included in the ITT analysis of the primary outcome, 58 were still on the treatment to which randomised at week 4.
    End point type
    Primary
    End point timeframe
    Week 4 DIS Score
    End point values
    		 Glycopyrronium Hyoscine
    Number of subjects analysed
    25
    33
    Units: number
        arithmetic mean (standard deviation)
    21.9 ( 11.7 )
    26.2 ( 15.5 )
    Statistical analysis title
    		 Difference in mean scores week 4 DIS Scores
    Comparison groups
    Glycopyrronium v Hyoscine
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 11.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.7

    Secondary: Week-12 DIS Scores

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    End point title
    		 Week-12 DIS Scores
    End point description
    The analysis set is the Intention to treat (ITT) set.
    End point type
    Secondary
    End point timeframe
    Week-12 DIS Scores
    End point values
    		 Glycopyrronium Hyoscine
    Number of subjects analysed
    33
    38
    Units: number
        arithmetic mean (standard deviation)
    23.8 ( 17.5 )
    31.0 ( 19.3 )
    No statistical analyses for this end point

    Secondary: Change in Drooling Severity-Frequency Scale (DSFS) score at baseline

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    End point title
    		 Change in Drooling Severity-Frequency Scale (DSFS) score at baseline
    End point description
    The analysis set is the Treatment Tolerated Set.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Glycopyrronium Hyoscine
    Number of subjects analysed
    33
    35
    Units: number
        arithmetic mean (standard deviation)
    7.6 ( 1.1 )
    7.6 ( 1.1 )
    No statistical analyses for this end point

    Secondary: Change in Drooling Severity-Frequency Scale (DSFS) score at week 4

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    End point title
    		 Change in Drooling Severity-Frequency Scale (DSFS) score at week 4
    End point description
    The analysis set is the Treatment Tolerated Set.
    End point type
    Secondary
    End point timeframe
    week 4
    End point values
    		 Glycopyrronium Hyoscine
    Number of subjects analysed
    33
    35
    Units: number
        arithmetic mean (standard deviation)
    4.7 ( 1.9 )
    5.1 ( 1.8 )
    No statistical analyses for this end point

    Secondary: Change in Drooling Severity-Frequency Scale (DSFS) score at week 12

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    End point title
    		 Change in Drooling Severity-Frequency Scale (DSFS) score at week 12
    End point description
    The analysis set is the Treatment Tolerated Set.
    End point type
    Secondary
    End point timeframe
    week 12
    End point values
    		 Glycopyrronium Hyoscine
    Number of subjects analysed
    31
    25
    Units: number
        arithmetic mean (standard deviation)
    4.7 ( 1.9 )
    4.7 ( 1.6 )
    No statistical analyses for this end point

    Secondary: Change in Treatment Satisfaction Questionnaire for Medication (TSQM) score at 4 weeks

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    End point title
    		 Change in Treatment Satisfaction Questionnaire for Medication (TSQM) score at 4 weeks
    End point description
    TSQM is a series of 11 questions coded and scored into 4 scales: effectiveness, side effects, convenience, global satisfaction. Each scale score is generated from selected questions and scaled to range from 0 to 100. Effectiveness: 0 extremely dissatisfied, 100 extremely satisfied Side effects: 0 extremely dissatisfied, 100 not at all dissatisfied Convenience: 0 extremely dissatisfied, 100 extremely satisfied Global satisfaction: 0 extremely dissatisfied, 100 extremely satisfied
    End point type
    Secondary
    End point timeframe
    4 week
    End point values
    		 Glycopyrronium Hyoscine
    Number of subjects analysed
    31
    33
    Units: number
    arithmetic mean (standard deviation)
        Effectiveness
    86.8 ( 9.8 )
    79.5 ( 17.2 )
        Side Effects
    98.1 ( 5.1 )
    96.0 ( 13.4 )
        Convenience
    85.8 ( 12.0 )
    79.1 ( 15.2 )
        Global score
    86.3 ( 13.5 )
    74.5 ( 15.6 )
    No statistical analyses for this end point

    Secondary: Week 12 DIS score- treatment tolerated set (TT)

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    End point title
    		 Week 12 DIS score- treatment tolerated set (TT)
    End point description
    The analysis set is the treatment tolerated set. Only those patients who tolerated their treatment and were still on the treatment to which randomised at week 12 are included in this analysis. 57 patients were still on the treatment to which randomised at week 12. 1 was still on treatment at week 12 but no DIS score was available. 4 had DIS assessments outside the required window (80 to 91 days inclusive).
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Glycopyrronium Hyoscine
    Number of subjects analysed
    29
    23
    Units: number
        arithmetic mean (standard deviation)
    19.6 ( 12.1 )
    21.9 ( 11.4 )
    Statistical analysis title
    		 Difference in mean scores week 12 DIS Scores
    Statistical analysis description
    The analysis set is the treatment tolerated set.
    Comparison groups
    Glycopyrronium v Hyoscine
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.3
         upper limit
    		 9
    Variability estimate
    Standard error of the mean

    Secondary: Comparison of week 4 vs week 12 DIS Scores

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    End point title
    		 Comparison of week 4 vs week 12 DIS Scores
    End point description
    Paired t-test. Results shown for each group separately.
    End point type
    Secondary
    End point timeframe
    Comparison of week 4 vs week 12 DIS Scores
    End point values
    		 Glycopyrronium Hyoscine
    Number of subjects analysed
    27
    36
    Units: number
        arithmetic mean (standard error)
    -1.1 ( 3.0 )
    1.4 ( 4.3 )
    Statistical analysis title
    		 Comparison of week 4 vs week 12 Glycopyrronium
    Comparison groups
    Hyoscine v Glycopyrronium
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 5.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    3
    Statistical analysis title
    		 Comparison of week 4 vs week 12 Hyoscine
    Comparison groups
    Hyoscine v Glycopyrronium
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.2
         upper limit
    		 10
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.3

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events will be recorded from randomisation to 52 week follow up.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 verbatim
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Hyoscine
    Reporting group description
    		 -

    Reporting group title
    Glycopyrronium
    Reporting group description
    		 -

    Serious adverse events
    		 Hyoscine Glycopyrronium
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 38 (2.63%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Gastroenteritis requiring IVs
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fracture left leg
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Hyoscine Glycopyrronium
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 47 (70.21%)
    6 / 38 (15.79%)
    Surgical and medical procedures
    Planned surgery
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Ataxia/Wobbliness
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    disturbed sleep, sleepwalking
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Hallucinations and hyperactivity
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    new secondary nocturnal enuresis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    possible brief seizure
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Decreased urinary frequency
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Did not tolerate wearing patch/ plaster. Did not like it.
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    early morning waking and hyperactivity
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Oral bleed
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    2
    macular papular rash on sternum
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Floppiness
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Hyper episode at night unable to sleep
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Hyperactivity
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 38 (2.63%)
         occurrences all number
    1
    1
    hyperactivity and deterioration in behaviour
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    local reaction to hyoscine
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Local skin reaction
         subjects affected / exposed
    8 / 47 (17.02%)
    0 / 38 (0.00%)
         occurrences all number
    12
    0
    local skin reaction, delayed sensitivity
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    local skin reaction to dressing
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Local skin reaction to hyoscine
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 38 (0.00%)
         occurrences all number
    4
    0
    local skin reaction to patch
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    local skin reaction, swelling and precipitated run of seizures within 30 minutes of applying patch
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Local skin reaction, red demarcated area under patch
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Local skin reaction, continued wks 11&12 & after trial. Continued patches 3 more months then stopped
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    overdrying of mouth
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    patches recurrently falling off
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Repeated pulling off of patch
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 38 (0.00%)
         occurrences all number
    3
    0
    self injury behaviour
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    sleepiness
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    standing and falling to floor, no loss of consciousness
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    wobbliness
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    allergic type reaction
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    visual blurring week 3
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Diarrhoea and vomiting
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    cough, illness
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    excessive drying of secretions
    Additional description: excessive drying of secretions sufficient enough to warrant mother deciding to stop
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    rash
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    redness and dry marks under patch
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    redness and itch under patch
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    redness under the plaster
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal and connective tissue disorders
    Fracture right arm
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jul 2013
    Substantial amendment 1 involved: The removal of the SMPC for Hyoscine and Glycopyrronium from the protocol appendices. Revision of the fax number for notifying SAEs and pregnancy. Addition and removal of the sites who will take part in the trial. Change of PI at Newcastle upon Tyne Hospitals NHS Foundation Trust.
    17 Sep 2013
    Administrative changes to protocol and CTA. Participant Information Sheet modified to include instructions to parents regarding the application of the occlusive dressing. Updates to monitoring of the study. Revised sIMPD confirming Glycopyrronium shelf life (6 months). Introduction of diary cards to record dose adjustments. Introduction of a nurses letter.
    12 Mar 2014
    Addition of trial sites.
    20 Jun 2014
    Addition of a trial site.
    31 Jul 2014
    Addition of sites.
    14 Nov 2014
    Update to sIMPD. Update to protocol.

    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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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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