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    Clinical Trial Results:
    Multi-center, double-blind, parallel-group, randomized, placebo-controlled, three doses, 40-week extension to studies ID-078A301 and ID-078A302 to assess the long term safety and tolerability of ACT-541468 in adult and elderly subjects with insomnia disorder

    Summary
    EudraCT number
    		 2017-004644-38
    Trial protocol
    		 DK   FI   SE   DE   CZ   FR   HU   ES   BG   BE   IT  
    Global end of trial date
    22 Feb 2021

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

    Trial information

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    Trial identification
    Sponsor protocol code
    ID-078A303
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03679884
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Idorsia Pharmaceuticals Ltd
    Sponsor organisation address
    Hegenheimermattweg 91, Allschwil, Switzerland, 4123
    Public contact
    Clinical Trials Disclosure Desk, Idorsia Pharmaceuticals Ltd, clinical-trials-disclosure@idorsia.com
    Scientific contact
    Clinical Trials Disclosure Desk, Idorsia Pharmaceuticals Ltd, clinical-trials-disclosure@idorsia.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Feb 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Feb 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this extension study was to assess the long-term safety and tolerability of 10, 25 and 50 mg ACT‒541468 (daridorexant).
    Protection of trial subjects
    Sponsor personnel and the investigators were required to conduct the study in full compliance with ICH-GCP guidelines, the principles of the “Declaration of Helsinki”, and with the laws and regulations of the countries in which the study was conducted. Both the sponsor and the investigator had the right to terminate the study at any time, and in such a case, were responsible for protecting the subjects’ interests. The investigator was responsible for maintaining the subjects’ identities in strictest confidence. Written informed consent was obtained from each individual participating in the study prior to any study procedure and after adequate explanation of the aims, methods, objectives, and potential hazards of the study. It was made clear to each subject that he or she was completely free to refuse to enter the study, or to withdraw from it at any time for any reason. An Independent Data Monitoring Committee (IDMC) had overall responsibility for safeguarding the interests of subjects by monitoring, in an unblinded manner, safety and efficacy data obtained in the study and making appropriate recommendations based on the reported data, thus ensuring that the study was conducted to the highest scientific and ethical standards.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Oct 2018
    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
    Poland: 7
    Country: Number of subjects enrolled
    Spain: 40
    Country: Number of subjects enrolled
    Sweden: 6
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Bulgaria: 46
    Country: Number of subjects enrolled
    Denmark: 32
    Country: Number of subjects enrolled
    Finland: 6
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 353
    Country: Number of subjects enrolled
    Hungary: 21
    Country: Number of subjects enrolled
    Canada: 26
    Country: Number of subjects enrolled
    Korea, Republic of: 6
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    United States: 257
    Worldwide total number of subjects
    804
    EEA total number of subjects
    513
    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)
    0
    Adults (18-64 years)
    469
    From 65 to 84 years
    334
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Ninety-four sites in 14 countries (Belgium, Bulgaria, Canada, Denmark, Finland, France, Germany, Hungary, South Korea, Poland, Spain, Sweden, Switzerland, and the US) enrolled and randomized subjects. Note: Subjects’ demographic and baseline characteristics were collected in the respective confirmatory study (ID-078A301 or 302).

    Pre-assignment
    Screening details
    		 Subjects assigned to the daridorexant arms in Study ID-078A301 and 302 received the same dose in the ID-078A303 extension study. Subjects assigned to the placebo arm in Study ID-078A301 and 302 were re-randomized to receive either placebo or 25 mg daridorexant in a 1:1 ratio, with treatment allocation stratified by age into two categories.

    Period 1
    Period 1 title
    DB treatment phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Daridorexant 10 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daridorexant 10 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daridorexant was administered during the DB treatment phase as film-coated tablets, taken orally once daily at bedtime at a dose of 10 mg.

    Arm title
    		 Daridorexant 25 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daridorexant 25 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daridorexant was administered during the DB treatment phase as film-coated tablets, taken orally once daily at bedtime at a dose of 25 mg.

    Arm title
    		 Daridorexant 50 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daridorexant 50 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daridorexant was administered during the DB treatment phase as film-coated tablets, taken orally once daily at bedtime at a dose of 50 mg.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo was administered during the DB treatment phase as film-coated tablets, taken orally once daily at bedtime.

    Arm title
    		 Ex-Placebo/Daridorexant 25 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ex-Placebo/Daridorexant 25 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daridorexant was administered during the DB treatment phase as film-coated tablets, taken orally once daily at bedtime at a dose of 25 mg.

    Number of subjects in period 1
    		Daridorexant 10 mg Daridorexant 25 mg Daridorexant 50 mg Placebo Ex-Placebo/Daridorexant 25 mg
    Started
    142
    270
    137
    128
    127
    Completed
    99
    190
    93
    78
    90
    Not completed
    43
    80
    44
    50
    37
         Adverse event, serious fatal
    1
    -
    -
    -
    -
         Consent withdrawn by subject
    12
    23
    8
    8
    9
         Adverse event, non-fatal
    2
    10
    9
    6
    6
         Other
    12
    12
    12
    7
    8
         Withdrawal prior to receiving DB treatment
    -
    2
    -
    -
    1
         Lost to follow-up
    1
    4
    2
    -
    3
         Lack of efficacy
    15
    29
    13
    29
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Daridorexant 10 mg
    Reporting group description
    		 -

    Reporting group title
    Daridorexant 25 mg
    Reporting group description
    		 -

    Reporting group title
    Daridorexant 50 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Ex-Placebo/Daridorexant 25 mg
    Reporting group description
    		 -

    Reporting group values
    		 Daridorexant 10 mg Daridorexant 25 mg Daridorexant 50 mg Placebo Ex-Placebo/Daridorexant 25 mg Total
    Number of subjects
    		 142 270 137 128 127 804
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 80 166 83 70 70 469
        >=65 years
    		 62 104 54 58 57 335
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.6 ± 12.8 57.6 ± 14.1 56.9 ± 13.6 59.2 ± 12.6 56.5 ± 15.5 -
    Gender categorical
    Units: Subjects
        Female
    		 103 199 98 92 83 575
        Male
    		 39 71 39 36 44 229

    End points

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    End points reporting groups
    Reporting group title
    Daridorexant 10 mg
    Reporting group description
    		 -

    Reporting group title
    Daridorexant 25 mg
    Reporting group description
    		 -

    Reporting group title
    Daridorexant 50 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Ex-Placebo/Daridorexant 25 mg
    Reporting group description
    		 -

    Primary: Total no. of subjects with at least one TEAE

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    End point title
    		 Total no. of subjects with at least one TEAE [1]
    End point description
    The primary objective of the study was to assess the long-term safety and tolerability of 10, 25 and 50 mg daridorexant. The total no. of subjects with at least one TEAE is presented here; no statistical analysis was conducted. The full set of safety data is available in the Section "Adverse events".
    End point type
    Primary
    End point timeframe
    TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported.
    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: The primary objective of the study was to assess the long-term safety and tolerability of 10, 25 and 50 mg daridorexant. The full set of safety data is available in the Section "Adverse events". No statistical analysis was conducted.
    End point values
    		 Daridorexant 10 mg Daridorexant 25 mg Daridorexant 50 mg Placebo Ex-Placebo/Daridorexant 25 mg
    Number of subjects analysed
    142
    268
    137
    128
    126
    Units: Subjects with at least one event
    53
    103
    55
    45
    48
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All treatment-emergent SAEs and AEs are reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Daridorexant 10 mg
    Reporting group description
    		 -

    Reporting group title
    Daridorexant 25 mg
    Reporting group description
    		 -

    Reporting group title
    Daridorexant 50 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Ex-Placebo/Daridorexant 25 mg
    Reporting group description
    		 -

    Serious adverse events
    		 Daridorexant 10 mg Daridorexant 25 mg Daridorexant 50 mg Placebo Ex-Placebo/Daridorexant 25 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 142 (3.52%)
    12 / 268 (4.48%)
    7 / 137 (5.11%)
    2 / 128 (1.56%)
    4 / 126 (3.17%)
         number of deaths (all causes)
    1
    1
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 268 (0.00%)
    1 / 137 (0.73%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 268 (0.37%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    2 / 142 (1.41%)
    0 / 268 (0.00%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Arteriosclerosis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 268 (0.37%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 268 (0.00%)
    1 / 137 (0.73%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 268 (0.37%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 268 (0.00%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 268 (0.37%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary mass
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 268 (0.37%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 268 (0.37%)
    1 / 137 (0.73%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 268 (0.37%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 268 (0.00%)
    0 / 137 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 268 (0.00%)
    0 / 137 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Wrist fracture
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 268 (0.00%)
    1 / 137 (0.73%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 268 (0.37%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 268 (0.00%)
    0 / 137 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 268 (0.00%)
    0 / 137 (0.00%)
    1 / 128 (0.78%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 142 (0.70%)
    1 / 268 (0.37%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bundle branch block left
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 268 (0.37%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 268 (0.37%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic valve disease mixed
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 268 (0.00%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Lethargy
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 268 (0.37%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orthostatic intolerance
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 268 (0.37%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 268 (0.00%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 268 (0.37%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 268 (0.37%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Thyroiditis subacute
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 268 (0.00%)
    1 / 137 (0.73%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone disorder
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 268 (0.00%)
    1 / 137 (0.73%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 268 (0.37%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 142 (0.70%)
    0 / 268 (0.00%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    0 / 142 (0.00%)
    2 / 268 (0.75%)
    1 / 137 (0.73%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 268 (0.00%)
    1 / 137 (0.73%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 142 (0.00%)
    1 / 268 (0.37%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 142 (0.00%)
    0 / 268 (0.00%)
    0 / 137 (0.00%)
    0 / 128 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Daridorexant 10 mg Daridorexant 25 mg Daridorexant 50 mg Placebo Ex-Placebo/Daridorexant 25 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 142 (4.93%)
    15 / 268 (5.60%)
    12 / 137 (8.76%)
    6 / 128 (4.69%)
    11 / 126 (8.73%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 142 (4.93%)
    15 / 268 (5.60%)
    12 / 137 (8.76%)
    6 / 128 (4.69%)
    11 / 126 (8.73%)
         occurrences all number
    10
    16
    13
    6
    11

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jul 2018
    It was clarified that subjects randomized to the placebo arm in ID-078A301 or ID-078A302 would be re-randomized to either placebo or daridorexant 25 mg in the ID-078A303 study in a 1:1 ratio, with treatment allocation stratified by age into two categories (< 65 and ≥ 65 years, as per the age entered at the screening visit in the ID-078A301 or ID-078A302 study).
    17 Feb 2020
    - The sponsor added an interim analysis for safety and efficacy to support regulatory filings, and an optional second interim analysis of safety if needed to fulfill health authority requirements. - It was clarified that, to maintain the integrity of the study after the interim analysis/analyses, participating subjects as well as investigators would remain blinded for the entire duration of the study. The sponsor personnel involved in data collection and medical monitoring of the extension study would also remain blinded until the end of the study. The sponsor made the following clarifications to endpoints: - Endpoints added for ESS, PGI-C and PGA-S. - Endpoint for subjective sleep efficiency removed. - C-SSRS© to be additionally analyzed for the placebo run-out period. - Rebound insomnia to be assessed with sTST only (sWASO and sLSO removed). - VAS scores for daytime alertness and daily ability to function to be analyzed as exploratory efficacy -endpoints instead of safety. - Endpoint added assessing the number (%) of subjects with ≥ 6 point decrease in ISI© total score from baseline.

    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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