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    Clinical Trial Results:
    A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy

    Summary
    EudraCT number
    		 2016-000359-29
    Trial protocol
    		 NL   DK   DE   GB   FI   CZ   FR  
    Global end of trial date
    25 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jan 2022
    First version publication date
    22 Jan 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLFT218-1501
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02720744
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Flamel Ireland Limited
    Sponsor organisation address
    10 Earlsfort Terrace, Dublin, Ireland, 2
    Public contact
    Clinical Trial Email, Flamel Ireland Limited, +001 636-449-1830,
    Scientific contact
    Clinical Trial Email, Flamel Ireland Limited, +001 636-449-1830,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Apr 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objectives To compare the efficacy of 6.0, 7.5, and 9.0 g of FT218 to placebo in treating excessive daytime sleepiness (EDS) in both type 1 narcolepsy (NT1) and type 2 narcolepsy (NT2) subjects as measured by mean sleep latency on the Maintenance of Wakefulness Test (MWT) and by the Clinical Global Impression (CGI) rating of sleepiness, and to compare the efficacy of 6.0, 7.5, and 9.0 g of FT218 to placebo in treating cataplexy in NT1 subjects as measured by the number of cataplexy attacks (NCA) determined from the cataplexy frequency item in the Sleep and Symptom Daily Diary.
    Protection of trial subjects
    A DSMB comprised of independent experts reviewed and assessed study conduct and advised the sponsor and investigators on matters relating to the safety and conduct of the study. The DSMB made recommendations to the sponsor and investigators regarding the continuation, modification, or termination of the study. To achieve this aim the DSMB periodically reviewed and evaluated accumulated study data relevant to subject safety, study progress, and conduct. The DSMB was governed by a charter and the membership of the DSMB reflected necessary clinical, scientific, and related disciplines necessary to interpret data from the clinical study to allow for full evaluation of subject safety.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Jul 2016
    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
    Netherlands: 1
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    Czech Republic: 2
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Australia: 11
    Country: Number of subjects enrolled
    United States: 116
    Country: Number of subjects enrolled
    Canada: 59
    Worldwide total number of subjects
    212
    EEA total number of subjects
    26
    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)
    11
    Adults (18-64 years)
    198
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 71 centers in Australia, Canada, Czech Republic, Denmark, Finland, France, Germany, Netherlands, Switzerland, the United Kingdom (UK), and the US. A total of 65 centers enrolled subjects.

    Pre-assignment
    Screening details
    		 3 week screening and baseline period, including 2 study visits and completion of the subject daily sleep and symptom diary to collect endpoint data, including cataplexy events for NT1 subjects and weekly ESS for all patients. Subjects were evaluated for eligibility at the end of the screening period.

    Pre-assignment period milestones
    Number of subjects started
    		 413 [1]
    Intermediate milestone: Number of subjects
    Randomized: 222
    Number of subjects completed
    		 212

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screen Failure: 201
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 413 patients were screened for the study, however only 222 were randomized. Of the 222 patients randomized, only 212 were actually administered study medication and included in the safety population.
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Matched placebo, IRT, central scoring laboratory for the sleep studies i.e. MWT.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FT218
    Arm description
    		 Patients treated with FT218, once nightly sodium oxybate granules for oral suspension.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Once Nightly Sodium Oxybate - Granules for oral suspension
    Investigational medicinal product code
    FT218
    Other name
    Pharmaceutical forms
    Coated granules in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were titrated to a maximum 9g stable dose over 13 treatment weeks. FT218 is reconstituted in water and administered once nightly at bedtime.

    Arm title
    		 Placebo
    Arm description
    		 Matching Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matched Placeboo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Coated granules in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage form and administration matched the active FT218 treatment arm.

    Number of subjects in period 1
    		FT218 Placebo
    Started
    107
    105
    Completed
    69
    79
    Not completed
    38
    26
         Consent withdrawn by subject
    11
    11
         Lack of Efficacy
    2
    8
         Non-compliance with Study Drug
    -
    1
         Adverse event, non-fatal
    21
    3
         Pregnancy
    2
    -
         other
    2
    1
         Protocol deviation
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FT218
    Reporting group description
    		 Patients treated with FT218, once nightly sodium oxybate granules for oral suspension.

    Reporting group title
    Placebo
    Reporting group description
    		 Matching Placebo

    Reporting group values
    		 FT218 Placebo Total
    Number of subjects
    		 107 105 212
    Age categorical
    Date of Birth (per country regulation) information was collected in the eCRF.
    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
    Date of Birth (per country regulations) was collected via the eCRF.
    Units: years
        median (standard deviation)
    		 29 ± 10.7 30 ± 11.24 -
    Gender categorical
    Units: Subjects
        Female
    		 69 75 144
        Male
    		 38 30 68
    Diagnosis Type
    Narcolepsy Type
    Units: Subjects
        NT1
    		 80 82 162
        NT2
    		 27 23 50
    Subject analysis sets

    Subject analysis set title
    FT218 Safety Group
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All enrolled subjects who administered at least 1 dose of study medication (FT218 Group).

    Subject analysis set title
    FT218 mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized subjects who were treated with study medication and completed at least 1 efficacy assessment at the 6g dose (FT218 Group).

    Subject analysis set title
    Placebo Safety Group
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All enrolled subjects who administered at least 1 dose of study medication (Placebo Group).

    Subject analysis set title
    Placebo mITT Group
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized subjects who were treated with study medication and completed at least 1 efficacy assessment at the 6g dose (Placebo Group).

    Subject analysis sets values
    		 FT218 Safety Group FT218 mITT Placebo Safety Group Placebo mITT Group
    Number of subjects
    107
    97
    105
    93
    Age categorical
    Date of Birth (per country regulation) information was collected in the eCRF.
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Date of Birth (per country regulations) was collected via the eCRF.
    Units: years
        median (standard deviation)
    29 ± 10.95
    n/a ± n/a
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    144
        Male
    68
    Diagnosis Type
    Narcolepsy Type
    Units: Subjects
        NT1
    162
        NT2
    50

    End points

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    End points reporting groups
    Reporting group title
    FT218
    Reporting group description
    		 Patients treated with FT218, once nightly sodium oxybate granules for oral suspension.

    Reporting group title
    Placebo
    Reporting group description
    		 Matching Placebo

    Subject analysis set title
    FT218 Safety Group
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All enrolled subjects who administered at least 1 dose of study medication (FT218 Group).

    Subject analysis set title
    FT218 mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized subjects who were treated with study medication and completed at least 1 efficacy assessment at the 6g dose (FT218 Group).

    Subject analysis set title
    Placebo Safety Group
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All enrolled subjects who administered at least 1 dose of study medication (Placebo Group).

    Subject analysis set title
    Placebo mITT Group
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized subjects who were treated with study medication and completed at least 1 efficacy assessment at the 6g dose (Placebo Group).

    Primary: Maintainence of Wakefulness Test (MWT)

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    End point title
    		 Maintainence of Wakefulness Test (MWT)
    End point description
    The MWT is the mean latency across 5 naps, averaged over the test day
    End point type
    Primary
    End point timeframe
    Study Visit 8
    End point values
    		 FT218 mITT Placebo mITT Group
    Number of subjects analysed
    68
    78
    Units: Minutes
        arithmetic mean (confidence interval 95%)
    15.5 (13.13 to 17.86)
    9.39 (7.61 to 11.17)
    Statistical analysis title
    		 Maintenance of Wakefulness Test (MWT)
    Statistical analysis description
    Maintenance of Wakefulness Test (MWT) Mean Sleep Latency (Minutes) Change from Baseline to the End of 9.0g Treatment Period - MMRM Analysis (mITT Population)
    Comparison groups
    FT218 mITT v Placebo mITT Group
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.52
         upper limit
    		 8.75
    Variability estimate
    Standard error of the mean

    Primary: Clinical Global Impression of Improvement

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    End point title
    		 Clinical Global Impression of Improvement
    End point description
    The CGI is the clinician’s global impression of improvement in daytime sleepiness. For the CGI, a GLIMMIX model for binomial data with logit link was used to analyze the categorized CGI response, i.e., the proportions of subjects who were Very Much Improved or Much Improved as compared to baseline
    End point type
    Primary
    End point timeframe
    Study Visit 8
    End point values
    		 FT218 mITT Placebo mITT Group
    Number of subjects analysed
    69
    79
    Units: Percentage
        number (not applicable)
    72
    31.6
    Statistical analysis title
    		 Clinical Global Impression (CGI) - Improvement
    Statistical analysis description
    Clinical Global Impression - Improvement (CGI-I) by the End of 9.0g Treatment Period - GLIMMIX Model (mITT Population)
    Comparison groups
    FT218 mITT v Placebo mITT Group
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 GLIMMIX
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    5.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.76
         upper limit
    		 11.23

    Primary: Number of Cataplexy Attacks

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    End point title
    		 Number of Cataplexy Attacks
    End point description
    The NCA was the mean number of cataplexy events recorded on the SSDD during the treatment period
    End point type
    Primary
    End point timeframe
    Visit 8 - Change from Baseline
    End point values
    		 FT218 mITT Placebo mITT Group
    Number of subjects analysed
    54
    62
    Units: NCA
        log mean (confidence interval 95%)
    -11.521 (-12.960 to -10.081)
    -4.938 (-6.206 to -3.669)
    Statistical analysis title
    		 Mean Weekly Number of Cataplexy Attacks (NCA)
    Statistical analysis description
    Mean Weekly Number of Cataplexy Attacks (NCA) of Each Dosing Period, Change from Baseline to the End of 9.0g Treatment Period - MMRM Analysis (NT1 Subjects in mITT Population)
    Comparison groups
    FT218 mITT v Placebo mITT Group
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -6.648
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.315
         upper limit
    		 -3.98
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.963

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE data were obtained at all study visits (scheduled or unscheduled) from the time of the signing of informed consent until seven days after the last dose of study drug.
    Adverse event reporting additional description
    Safety was evaluated based on reports of AEs either spontaneously reported or observed in clinical laboratory analyses.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    9g FT218 Group
    Reporting group description
    		 Subjects dosing with FT218

    Reporting group title
    9g Placebo Group
    Reporting group description
    		 9g dosing period - subjects dosing with placebo

    Serious adverse events
    		 9g FT218 Group 9g Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 107 (4.67%)
    2 / 105 (1.90%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Perirectal abscess
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic inflammatory disease
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 105 (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: 2%
    Non-serious adverse events
    		 9g FT218 Group 9g Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    83 / 107 (77.57%)
    50 / 105 (47.62%)
    Cardiac disorders
    Dyspnoea
         subjects affected / exposed
    4 / 107 (3.74%)
    0 / 105 (0.00%)
         occurrences all number
    4
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    17 / 107 (15.89%)
    0 / 105 (0.00%)
         occurrences all number
    20
    0
    Somnolence
         subjects affected / exposed
    5 / 107 (4.67%)
    1 / 105 (0.95%)
         occurrences all number
    6
    1
    Headache
         subjects affected / exposed
    20 / 107 (18.69%)
    12 / 105 (11.43%)
         occurrences all number
    25
    13
    Abnormal dreams
         subjects affected / exposed
    5 / 107 (4.67%)
    0 / 105 (0.00%)
         occurrences all number
    5
    0
    Paraesthesia
         subjects affected / exposed
    4 / 107 (3.74%)
    0 / 105 (0.00%)
         occurrences all number
    4
    0
    Hypoaesthesia
         subjects affected / exposed
    3 / 107 (2.80%)
    0 / 105 (0.00%)
         occurrences all number
    4
    0
    Sleep paralysis
         subjects affected / exposed
    3 / 107 (2.80%)
    0 / 105 (0.00%)
         occurrences all number
    4
    0
    Somnambulism
         subjects affected / exposed
    3 / 107 (2.80%)
    0 / 105 (0.00%)
         occurrences all number
    3
    0
    Tremor
         subjects affected / exposed
    3 / 107 (2.80%)
    0 / 105 (0.00%)
         occurrences all number
    3
    0
    General disorders and administration site conditions
    Hyperhidrosis
         subjects affected / exposed
    6 / 107 (5.61%)
    0 / 105 (0.00%)
         occurrences all number
    6
    0
    Asthenia
         subjects affected / exposed
    4 / 107 (3.74%)
    1 / 105 (0.95%)
         occurrences all number
    4
    1
    Fatigue
         subjects affected / exposed
    3 / 107 (2.80%)
    1 / 105 (0.95%)
         occurrences all number
    3
    1
    Pain
         subjects affected / exposed
    3 / 107 (2.80%)
    0 / 105 (0.00%)
         occurrences all number
    3
    0
    Pyrexia
         subjects affected / exposed
    3 / 107 (2.80%)
    3 / 105 (2.86%)
         occurrences all number
    4
    3
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    3 / 107 (2.80%)
    0 / 105 (0.00%)
         occurrences all number
    4
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    19 / 107 (17.76%)
    4 / 105 (3.81%)
         occurrences all number
    27
    4
    Nausea
         subjects affected / exposed
    3 / 107 (2.80%)
    4 / 105 (3.81%)
         occurrences all number
    3
    4
    Upper Abdominal Pain
         subjects affected / exposed
    2 / 107 (1.87%)
    0 / 105 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    4 / 107 (3.74%)
    0 / 105 (0.00%)
         occurrences all number
    4
    0
    Dry mouth
         subjects affected / exposed
    4 / 107 (3.74%)
    2 / 105 (1.90%)
         occurrences all number
    4
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 107 (2.80%)
    4 / 105 (3.81%)
         occurrences all number
    3
    4
    Psychiatric disorders
    Enuresis
         subjects affected / exposed
    17 / 107 (15.89%)
    0 / 105 (0.00%)
         occurrences all number
    23
    0
    Anxiety
         subjects affected / exposed
    8 / 107 (7.48%)
    3 / 105 (2.86%)
         occurrences all number
    8
    4
    Depression
         subjects affected / exposed
    3 / 107 (2.80%)
    1 / 105 (0.95%)
         occurrences all number
    3
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 107 (3.74%)
    2 / 105 (1.90%)
         occurrences all number
    5
    2
    Pain in Extremity
         subjects affected / exposed
    4 / 107 (3.74%)
    2 / 105 (1.90%)
         occurrences all number
    4
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 107 (5.61%)
    7 / 105 (6.67%)
         occurrences all number
    7
    7
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 107 (2.80%)
    2 / 105 (1.90%)
         occurrences all number
    3
    2
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    13 / 107 (12.15%)
    0 / 105 (0.00%)
         occurrences all number
    14
    0
    Weight decreased
         subjects affected / exposed
    6 / 107 (5.61%)
    1 / 105 (0.95%)
         occurrences all number
    6
    1

    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
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