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    Clinical Trial Results:
    A RANDOMIZED, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF CIRCADIN® TO ALLEVIATE SLEEP DISTURBANCES IN CHILDREN WITH NEURODEVELOPMENTAL DISABILITIES

    Summary
    EudraCT number
    		 2013-001832-23
    Trial protocol
    		 Outside EU/EEA   FI   GB   NL   FR  
    Global end of trial date
    28 Feb 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Sep 2018
    First version publication date
    12 Sep 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NEU_CH_7911
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01906866
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Neurim Pharmaceuticals
    Sponsor organisation address
    Habarzel 27, Tel Aviv, Israel,
    Public contact
    VP Clinical and Regulatory Affairs, Neurim Pharmaceuticals (1991) Ltd., Talin@neurim.com
    Scientific contact
    VP Clinical and Regulatory Affairs, Neurim Pharmaceuticals (1991) Ltd., talin@neurim.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000440-PIP02-11
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Feb 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the treatment effect of Circadin 2/5 mg to that of placebo on sleep maintenance (total sleep time [TST]) as assessed by the Sleep and Nap Diary after 13 weeks of double-blind treatment.
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Regulatory reason
    Long term follow-up duration
    		 21 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 20
    Country: Number of subjects enrolled
    United Kingdom: 35
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    United States: 200
    Country: Number of subjects enrolled
    Finland: 5
    Worldwide total number of subjects
    267
    EEA total number of subjects
    67
    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)
    174
    Adolescents (12-17 years)
    93
    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
    		 Recruitment started on December 2013 first patient first visit was on January 2014 last patient last visit on February 28th 2018

    Pre-assignment
    Screening details
    		 A screening visit was conducted 4 weeks prior to randomization. Children who did not have a documented history of sleep hygiene and behavioral intervention at screening underwent 4 weeks of basic sleep hygiene and behavioral intervention (Weeks -4 to 0). This period also served as a wash-out period from any hypnotics; a gradual withdrawal took plac

    Period 1
    Period 1 title
    placebo run-in
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Arm title
    		 placebo
    Arm description
    		 single blind
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    2 mini-tablets 0.5-1 hour before bedtime.

    Number of subjects in period 1
    		placebo
    Started
    267
    Completed
    125
    Not completed
    142
         non eligible
    142
    Period 2
    Period 2 title
    double blind
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental
    Arm description
    		 Experimental product - 2 mg or 5 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Melatonin prolonged release
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Buccal tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    2 mg for the first 3 weeks double blind period. After 3 weeks of double-blind treatment, on the last day of Week 5 ±3 days (Visit 3), sleep variables were assessed to determine if dose modification (an increase to 5 mg) was required. Children who did not improve by 60 minutes in TST, sleep latency or both at this time were eligible for dose increase. Children then continued on 2 or 5 mg of Circadin® or placebo for the remaining 10 weeks of double-blind treatment, with an efficacy assessment visit at Week 15 (Visit 4).

    Arm title
    		 placebo
    Arm description
    		 placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    2 / 5 / 10 mini-tablets 0.5-1 hour before bedtime.

    Number of subjects in period 2
    		Experimental placebo
    Started
    60
    65
    Completed
    51
    44
    Not completed
    9
    21
         Consent withdrawn by subject
    3
    13
         Physician decision
    1
    1
         Adverse event, non-fatal
    1
    -
         other
    -
    2
         Lost to follow-up
    2
    5
         Protocol deviation
    2
    -
    Period 3
    Period 3 title
    open-label
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 experimental
    Arm description
    		 prolonged release melatonin 2, 5 or 10 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    prolonged release melatonin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    2 or 5 or 10 mg of prolonged release melatonin pediatric formulation; 0.5-1 hour before bed-time ;

    Investigational medicinal product name
    prolonged release melatonin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    2 or 5 or 10 mg of prolonged release melatonin pediatric formulation; 0.5-1 hour before bed-time ;

    Number of subjects in period 3
    		experimental
    Started
    95
    Completed
    74
    Not completed
    21
         consent withdrawn by parents
    9
         Consent withdrawn by subject
    3
         Physician decision
    2
         Adverse event, non-fatal
    3
         other
    1
         Lost to follow-up
    1
         Protocol deviation
    2
    Period 4
    Period 4 title
    single-blind run-out
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Arm title
    		 placebo
    Arm description
    		 placebo run-out
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    two, five or ten mini-tablets buccal use 0.5-1 hour before bedtime for two weeks of the period

    Number of subjects in period 4
    		placebo
    Started
    74
    Completed
    73
    Not completed
    1
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    placebo run-in
    Reporting group description
    		 -

    Reporting group values
    		 placebo run-in Total
    Number of subjects
    		 267 267
    Age categorical
    Age 2 -18 years old
    Units: Subjects
        Children (2-11 years)
    		 174 174
        Adolescents (12-17 years)
    		 93 93
    Age continuous
    mean age
    Units: years
        arithmetic mean (standard deviation)
    		 8.6 ± 4.12 -
    Gender categorical
    Units: Subjects
        Female
    		 71 71
        Male
    		 196 196
    Subject analysis sets

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients in the Safety Analysis Set who satisfied all major entry criteria (Inclusion Criteria 1-5) and who had a valid mean TST result recorded for baseline and at least one post-baseline period assessment during the double blind phase. Patients were classified according to randomized treatment. This analysis set was used for all efficacy analyses

    Subject analysis sets values
    		 FAS
    Number of subjects
    119
    Age categorical
    Age 2 -18 years old
    Units: Subjects
        Children (2-11 years)
    78
        Adolescents (12-17 years)
    41
    Age continuous
    mean age
    Units: years
        arithmetic mean (standard deviation)
    8.7 ± 4.15
    Gender categorical
    Units: Subjects
        Female
    30
        Male
    89

    End points

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    End points reporting groups
    Reporting group title
    placebo
    Reporting group description
    		 single blind
    Reporting group title
    Experimental
    Reporting group description
    		 Experimental product - 2 mg or 5 mg

    Reporting group title
    placebo
    Reporting group description
    		 placebo
    Reporting group title
    experimental
    Reporting group description
    		 prolonged release melatonin 2, 5 or 10 mg
    Reporting group title
    placebo
    Reporting group description
    		 placebo run-out

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients in the Safety Analysis Set who satisfied all major entry criteria (Inclusion Criteria 1-5) and who had a valid mean TST result recorded for baseline and at least one post-baseline period assessment during the double blind phase. Patients were classified according to randomized treatment. This analysis set was used for all efficacy analyses

    Primary: total sleep time

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    End point title
    		 total sleep time
    End point description
    • To compare the treatment effect of Circadin® 2/5 mg minitablets to that of placebo on total sleep time (TST) as assessed by the Sleep and Nap Diary after 13 weeks of double-blind treatment
    End point type
    Primary
    End point timeframe
    13 weeks
    End point values
    		 Experimental placebo
    Number of subjects analysed
    58
    61
    Units: minutes
        arithmetic mean (standard error)
    51.03 ± 10.46
    18.71 ± 10.82
    Attachments
    		 Total Sleep Time
    Statistical analysis title
    		 MMRM
    Comparison groups
    Experimental v placebo
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 MMRM
    Statistical analysis description
    mixed-effects model for repeated-measures
    Comparison groups
    Experimental v placebo
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.035
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    32.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.38
         upper limit
    		 62.26
    Variability estimate
    Standard error of the mean
    Dispersion value
    15.1

    Secondary: Sleep Latency

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    End point title
    		 Sleep Latency
    End point description
    • To compare the treatment effect of Circadin® 2/5 mg minitablets to that of placebo on sleep latency as derived from a Sleep and Nap Diary after 13 weeks of double-blind treatment
    End point type
    Secondary
    End point timeframe
    13 weeks
    End point values
    		 Experimental placebo
    Number of subjects analysed
    58
    61
    Units: minutes
        arithmetic mean (standard error)
    -37.77 ± 6.816
    -12.57 ± 7.005
    Attachments
    		 Sleep Latency
    Statistical analysis title
    		 MMRM
    Statistical analysis description
    mixed-effects model for repeated-measures
    Comparison groups
    Experimental v placebo
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.011
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -25.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -44.61
         upper limit
    		 -5.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.787

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    104 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    placebo DB
    Reporting group description
    		 adverse events during the double blind period on placebo 13 weeks

    Reporting group title
    prolonged release melatonin OL
    Reporting group description
    		 Prolonged release melatonin during the open label period 91 weeks

    Reporting group title
    prolonged release melatonin DB
    Reporting group description
    		 prolonged release melatonin double blind period 13 weeks

    Serious adverse events
    		 placebo DB prolonged release melatonin OL prolonged release melatonin DB
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 65 (1.54%)
    6 / 95 (6.32%)
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Gastrointestinal disorders
    CONSTIPATION
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 95 (1.05%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    AGGRESSION
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 95 (1.05%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    OPPOSITIONAL DEFIANT DISORDER
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 95 (1.05%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abnormal behaviour
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 95 (1.05%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    PNEUMONIA
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 95 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RESPIRATORY TRACT INFECTION VIRAL
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 95 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    EYE INFECTION
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 95 (1.05%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    OTITIS MEDIA ACUTE
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 95 (1.05%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 placebo DB prolonged release melatonin OL prolonged release melatonin DB
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 65 (76.92%)
    80 / 95 (84.21%)
    51 / 60 (85.00%)
    Nervous system disorders
    SOMNOLENCE
         subjects affected / exposed
    8 / 65 (12.31%)
    24 / 95 (25.26%)
    17 / 60 (28.33%)
         occurrences all number
    8
    31
    18
    HEADACHE
         subjects affected / exposed
    4 / 65 (6.15%)
    12 / 95 (12.63%)
    8 / 60 (13.33%)
         occurrences all number
    4
    12
    8
    DIZZINESS
         subjects affected / exposed
    0 / 65 (0.00%)
    6 / 95 (6.32%)
    0 / 60 (0.00%)
         occurrences all number
    0
    8
    0
    General disorders and administration site conditions
    FATIGUE
         subjects affected / exposed
    12 / 65 (18.46%)
    25 / 95 (26.32%)
    15 / 60 (25.00%)
         occurrences all number
    13
    33
    19
    PYREXIA
         subjects affected / exposed
    4 / 65 (6.15%)
    7 / 95 (7.37%)
    5 / 60 (8.33%)
         occurrences all number
    4
    8
    5
    HANGOVER
         subjects affected / exposed
    3 / 65 (4.62%)
    7 / 95 (7.37%)
    3 / 60 (5.00%)
         occurrences all number
    4
    8
    4
    Gastrointestinal disorders
    VOMITING
         subjects affected / exposed
    10 / 65 (15.38%)
    20 / 95 (21.05%)
    8 / 60 (13.33%)
         occurrences all number
    10
    33
    11
    DIARRHOEA
         subjects affected / exposed
    3 / 65 (4.62%)
    3 / 95 (3.16%)
    3 / 60 (5.00%)
         occurrences all number
    4
    3
    3
    NAUSEA
         subjects affected / exposed
    1 / 65 (1.54%)
    9 / 95 (9.47%)
    4 / 60 (6.67%)
         occurrences all number
    1
    11
    4
    CONSTIPATION
         subjects affected / exposed
    1 / 65 (1.54%)
    8 / 95 (8.42%)
    3 / 60 (5.00%)
         occurrences all number
    1
    11
    4
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    5 / 65 (7.69%)
    16 / 95 (16.84%)
    7 / 60 (11.67%)
         occurrences all number
    5
    27
    7
    DYSPNOEA
         subjects affected / exposed
    4 / 65 (6.15%)
    10 / 95 (10.53%)
    6 / 60 (10.00%)
         occurrences all number
    4
    10
    6
    ASTHMA
         subjects affected / exposed
    1 / 65 (1.54%)
    6 / 95 (6.32%)
    1 / 60 (1.67%)
         occurrences all number
    1
    8
    1
    RHINORRHOEA
         subjects affected / exposed
    0 / 65 (0.00%)
    5 / 95 (5.26%)
    2 / 60 (3.33%)
         occurrences all number
    0
    5
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    3 / 65 (4.62%)
    10 / 95 (10.53%)
    3 / 60 (5.00%)
         occurrences all number
    3
    10
    3
    Psychiatric disorders
    MOOD SWINGS
         subjects affected / exposed
    11 / 65 (16.92%)
    17 / 95 (17.89%)
    10 / 60 (16.67%)
         occurrences all number
    12
    24
    10
    AGITATION
         subjects affected / exposed
    7 / 65 (10.77%)
    8 / 95 (8.42%)
    11 / 60 (18.33%)
         occurrences all number
    8
    10
    12
    ANXIETY
         subjects affected / exposed
    0 / 65 (0.00%)
    6 / 95 (6.32%)
    0 / 60 (0.00%)
         occurrences all number
    0
    8
    0
    AGGRESSION
         subjects affected / exposed
    0 / 65 (0.00%)
    5 / 95 (5.26%)
    0 / 60 (0.00%)
         occurrences all number
    0
    5
    0
    Infections and infestations
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    7 / 65 (10.77%)
    14 / 95 (14.74%)
    9 / 60 (15.00%)
         occurrences all number
    8
    24
    9
    INFLUENZA
         subjects affected / exposed
    0 / 65 (0.00%)
    8 / 95 (8.42%)
    0 / 60 (0.00%)
         occurrences all number
    0
    8
    0
    OTITIS MEDIA
         subjects affected / exposed
    0 / 65 (0.00%)
    7 / 95 (7.37%)
    0 / 60 (0.00%)
         occurrences all number
    0
    8
    0
    GASTROENTERITIS
         subjects affected / exposed
    0 / 65 (0.00%)
    6 / 95 (6.32%)
    0 / 60 (0.00%)
         occurrences all number
    0
    8
    0
    NASOPHARYNGITIS
         subjects affected / exposed
    0 / 65 (0.00%)
    6 / 95 (6.32%)
    0 / 60 (0.00%)
         occurrences all number
    0
    8
    0
    SINUSITIS
         subjects affected / exposed
    0 / 65 (0.00%)
    5 / 95 (5.26%)
    0 / 60 (0.00%)
         occurrences all number
    0
    5
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29096777
    http://www.ncbi.nlm.nih.gov/pubmed/30132686
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