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    Summary
    EudraCT Number:2017-004642-20
    Sponsor's Protocol Code Number:ID-078A301
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-02-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-004642-20
    A.3Full title of the trial
    Multi-center, double-blind, randomized, placebo-controlled, parallel-group, polysomnography study to assess the efficacy and safety of ACT-541468 in
    adult and elderly subjects with insomnia disorder.
    Studio multicentrico, in doppio cieco, randomizzato, controllato con placebo, a gruppi paralleli, polisonnografico per valutare l'efficacia e la sicurezza di ACT-541468 in soggetti adulti e anziani con il disturbo dell’insonnia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the efficacy and safety of ACT-541468 in adult and elderly subjects suffering from difficulties to sleep.
    Studio di valutazione dell'efficacia e della sicurezza di ACT-541468 negli adulti e negli anziani che soffrono di problemi di sonno.
    A.3.2Name or abbreviated title of the trial where available
    Multi-center, double-blind, randomized, placebo-controlled, parallel-group, polysomnography study to
    Studio multicentrico, in doppio cieco, randomizzato, controllato con placebo, a gruppi paralleli, po
    A.4.1Sponsor's protocol code numberID-078A301
    A.5.4Other Identifiers
    Name:ID-078A301Number:ID-078A301
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIDORSIA PHARMACEUTICALS LTD
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIdorsia Pharmaceuticals Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIdorsia Pharmaceuticals Ltd
    B.5.2Functional name of contact pointClinical Trial Disclosure Desk
    B.5.3 Address:
    B.5.3.1Street AddressHegenheimermattweg 91
    B.5.3.2Town/ cityAllschwill
    B.5.3.3Post code4123
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041588440361
    B.5.5Fax number0041588440108
    B.5.6E-mailclinical-trials-disclosure@idorsia.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNA
    D.3.2Product code [ACT-541468]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeACT-541468
    D.3.9.4EV Substance CodeSUB188259
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNA
    D.3.2Product code [ACT-541468]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeACT-541468
    D.3.9.4EV Substance CodeSUB188259
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Insomnia disorder.
    Insonnia.
    E.1.1.1Medical condition in easily understood language
    Difficulty to sleep.
    Disturbi del sonno.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10022437
    E.1.2Term Insomnia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of 25 mg and 50 mg ACT-541468 on objective sleep parameters in subjects with insomnia disorder.
    Valutare l'efficacia di ACT-541468 25 mg e 50 mg su parametri oggettivi del sonno in soggetti affetti da insonnia.
    E.2.2Secondary objectives of the trial
    a) To evaluate the efficacy of 25 mg and 50 mg ACT-541468 on subjective sleep parameters and next-day functioning in subjects with insomnia disorder; b) To assess the safety and tolerability of ACT-541468 in subjects with insomnia disorder during treatment and upon treatment discontinuation.
    a) Valutare l'efficacia di ACT-541468 25 mg e 50 mg sui parametri del sonno soggettivo e sulle prestazioni funzionali del giorno successivo in soggetti affetti da insonnia; b) Valutare la sicurezza e la tollerabilità di ACT-541468 in soggetti affetti da insonnia durante il trattamento e dopo l'interruzione del trattamento.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: A sub-study [PAtient Preferences StUdy in InSomnia (PAUSe)] to collect data on the subject's preferences will be performed, aiming to enroll at least 360 subjects both from the USA and Germany who are part of the approximately 900 subjects enrolled in the ID-078A301 study. This sub-study has the following objectives: 1) To describe the stated preferences of insomnia disorder subjects within a clinical trial by
    applying the DCE technique; 2) To describe the impact of treatment on the preferences of insomnia subjects; 3) To describe the relationship between demographic, disease characteristics, previous
    medical history and elicited preferences among insomnia subjects. In addition, the results of the sub-study may contribute to the construction
    of a patient-oriented benefit-risk assessment model.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Verrà eseguito uno studio secondario per raccogliere i dati sulle preferenze del paziente. La metodologia Discrete Choice Experiment mira a raccogliere le preferenze per gli esiti del trattamento selezionati in un sottogruppo di almeno 360 soggetti negli Stati Uniti e in Germania che fanno parte dei circa 900 soggetti arruolati nello studio ID-078A301, utilizzando il questionario per il ruolo delle preferenze paziente in InSomnia (PAUSe) sviluppato da Idorsia.

    E.3Principal inclusion criteria
    a) Signed informed consent prior to any study-mandated procedure; b) Male or female aged = 18 years; c) Insomnia disorder according to DSM-5 criteria; d) Insomnia Severity Index score = 15; e) Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography; f) Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake.
    a) Consenso informato firmato prima di qualsiasi procedura di studio; b) Uomini o donne di età = 18 anni; c) diagnosi di Insonnia secondo DSM-5; d) Punteggio alla scala ISI = 15; e) insufficiente quantità di sonno come documentato soggettivamente nel diario del paziente e confermato oggettivamente dalla polisonnografia; f) Per le donne in età fertile è richiesto un test di gravidanza negativo e l'uso di un metodo contraccettivo per almeno 30 giorni dopo l'ultimo trattamento.
    E.4Principal exclusion criteria
    a) Body mass index below 18.5 or above 40.0 kg/m2; b) Any lifetime history of sleep-related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or
    apnea/hypopnea; c) Cognitive behavioral therapy (CBT) for any indication is allowed, only, if CBT started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study; d) Self-reported usual daytime napping = 1 hour per day and = 3 days per week; e) Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview; f) Mini Mental State Examination (MMSE) score < 25 in subjects = 50 years; g) For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study; h) History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments; i) Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
    a) Indice di massa corporea inferiore a 18,5 o superiore a 40,0 kg/m2; b) Qualsiasi anamnesi di disordini del respiro collegati al sonno, disordini periodici di movimenti delle gamber, sintomi delle gambe irrequiete, disordini del ritmo circadiano, movimenti rapidi oculari (REM), disordini del comportamento, narcolesia, o apnea / ipopnea; c) La terapia cognitiva comportamentale (CBT) per qualunque indicazione è consentita solo se la terapia CBT è iniziata almeno 1 mese prima di Visita 3 e l'interessato accetta di continuare la CBT durante lo studio; d) Riposo giornaliero abituale riferito = 1 ora al giorno e = 3 giorni a settimana; e) condizioni psichiatriche acute o instabili diagnosticati dal Mini International Neuropsychiatric Interview; f) Risultato del Mini Mental State Esamination <25 in soggetti = 50 anni; g) donne in gravidanza o allattamento o determinate ad avere una gravidanza nel corso dello studio; h) storia o evidenza clinica di qualsiasi malattia o condizione medica o trattamento, che possa mettere il paziente a rischio durante la partecipazione allo studio o possa interferire con le valutazioni dello studio; i) qualsiasi circostanza o condizione, che, nell'opinione dello sperimentatore, possa influire sulla piena partecipazione del soggetto allo studio o l'aderenza al protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    a) The change from baseline to Month 1 in Wake After Sleep Onset (WASO) (sleep maintenance); b) The change from baseline to Month 3 in Wake After Sleep Onset (WASO); c) The change from baseline to Month 1 in Latency to Persistent Sleep (LPS) (sleep onset); d) The change from baseline to Month 3 in Latency to Persistent Sleep (LPS).
    a) il cambiamento dal basale al mese 1 nel WASO (mantenimento del sonno); b) il cambiamento dal baseline al mese 3 nel WASO; c) il cambiamento dal baseline al mese 1 nell’LPS (inizio del sonno); d) il cambiamento dal baseline al mese 3 in LPS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    a) From baseline to Month 1; b) From baseline to Month 3; c) From baseline to Month 1; d) From baseline to Month 3.
    a) Dalla baseline al mese 1; b) Dalla baseline al mese 3; c) Dalla baseline al mese 1; d) Dalla baseline al mese 3.
    E.5.2Secondary end point(s)
    1. The change from baseline to Month 1 in the subjective Total Sleep Time (sTST); 2. The change from baseline to Month 3 in the subjective Total Sleep Time (sTST); 3. The change from baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) sleepiness domain score; 4. The change from baseline to Month 3 in IDSIQ sleepiness domain score.
    1) il cambiamento dal Basale al Mese 1 nell’sTST; 2) il cambiamento dal Basale al Mese 3 nel sTST; 3) il cambiamento dal Basale al Mese 1 nel punteggio del dominio “sonnolenza” al Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ); 4) il cambiamento dal Basale al Mese 3 nel punteggio del dominio “sonnolenza” al Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From baseline to Month 1; 2. From baseline to Month 3; 3. From baseline to Month 1;4. From baseline to Month 3.
    1. Dal Basale al Mese 1; 2. Dal Basale al Mese 3; 3. Dal Basale al Mese 1; 4. Dal Basale al Mese 3.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Serbia
    United States
    Denmark
    Germany
    Italy
    Poland
    Spain
    Switzerland
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS, intended as last telephone call for the 30-day follow-up (Visit 11) or last date of enrolment into the ID-078A303 extension study.
    LVLS, inteso come ultimo contatto telefonico per i 30 giorni di follow-up (Visita 11) o ultima data di arruolamento nello studio di estensione ID-078A303.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 540
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 360
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 460
    F.4.2.2In the whole clinical trial 900
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects who do not prematurely discontinue the double-blind study treatment and completed the Run-out period will be eligible to enter the ID-078A303 extension study.
    I soggetti che non discontinuano prematuramente il trattamento nello studio in doppio cieco e completano il periodo di Run-out saranno arruolabili nello studio di estensione ID-078A303.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-12
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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