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    Summary
    EudraCT Number:2019-001520-35
    Sponsor's Protocol Code Number:MP-2019-001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-24
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-001520-35
    A.3Full title of the trial
    Efficacy of low dose amitriptyline vs. cognitive behavioural therapy for chronic insomnia and medical comorbidity: a randomized controlled non inferiority trial.
    Effectiviteit van een lage dosering amitriptyline versus cognitieve gedragstherapie bij insomnie en medische aandoeningen: een gerandomiseerd non-inferiority studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treating Insomnia with Medical comorbidity: Low dose Amitriptyline vs cognitive behavioral therapy
    Een lage dosering amitriptyline en cognitieve gedragstherapie bij langdurige slapeloosheid voor patiënten met een medische aandoening
    A.3.2Name or abbreviated title of the trial where available
    TIMELAPSE study
    TIMELAPSE studie
    A.4.1Sponsor's protocol code numberMP-2019-001
    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 SponsorHospital Gelderse Vallei
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAmsterdam Univesity Medical Centre
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Gelderse Vallei
    B.5.2Functional name of contact pointMedical Psychology
    B.5.3 Address:
    B.5.3.1Street AddressWilly Brandtlaan 10
    B.5.3.2Town/ cityEde
    B.5.3.3Post code6717 RP
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310318433850
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name AMITRIPTYLINE HCl 10 – 25 MG TEVA
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameamitriptyline
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Insomniadisorder
    Insomniastoornis
    E.1.1.1Medical condition in easily understood language
    Insomnia, sleeplesness
    Chronische slapeloosheid
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the study is to determine whether low dose amitriptyline (10-20 mg nightly) in chronic insomnia coexisting with medical conditions is as effective as CBT-I in improving subjective sleep.
    Het hoofddoel van de studie is om te bepalen of een lage dosis amitriptyline (10-20 mg) bij chronische slapeloosheid bij mensen met een medische aandoening even effectief als CGT-I ten aanzien van verbetering van de subjectieve slaap.
    E.2.2Secondary objectives of the trial
    Secondary objectives include (1) investigating the long-term efficacy of amitriptyline in comparison to CBT-I, (2) determining the effect on daytime symptoms and functioning, (3) determining whether the medication is well tolerated (safe) (4) identifying mediators and moderators of treatment outcome.
    Secundaire doelstellingen zijn onder andere (1) onderzoek naar de lange termijn werkzaamheid van amitriptyline in vergelijking met CGT-I, (2) bepalen van het effect op klachten en functioneren overdag, (3) om te bepalen of de medicatie goed verdragenwordt (veilig) (4) identificeren van mediatoren en moderatoren van de behandel uitkomst.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adults aged 18 – 85 years and older visiting the outpatient clinic department of neurology.
    - Presence of insomnia disorder conform DSM-5, i.e. sleep problems in at least 3 nights a week, for at least 3 months with consequences for daytime functioning, the sleep problem cannot be better explained by or occurs exclusively during the course of another sleep disorder (e.g. sleep related breathing disorder, parasomnia)
    - Score of ≥10 on the Insomnia Severity Index (ISI)
    - Have a medical condition and / or chronic pain (> 3 months).
    - Insomniastoornis conform DSM-5
    - Score van ≥10 op de Insomnia Severity Index (ISI)
    - Een medische aandoening of chronische pijn (. 3 maanden)
    E.4Principal exclusion criteria
    - Habitual night shift worker
    - Untreated sleep related breathing disorder
    - Wish to continue over-the-counter sleep aids as melatonin and medicinal cannabis
    - Use of off-label amitriptyline for insomnia in the past year
    - Being unable to follow study instructions and fill out the study questionnaires (in Dutch)
    - A known diagnosis of Dementia
    - Pregnancy, lactation or wish to become pregnant in the coming 6 months
    - Terminal illness (prognosis < 1 year)
    - Suicide risk
    - Epilepsy
    - Ocular Hypertension / Glaucoma
    - The presence of a severe psychiatric disorder not in remission or adequately treated.
    - Current alcohol or drug abuse/addiction (benzodiazepine excluded).
    - Participation in other interventional medical scientific studies
    - Current use of psychopharmaceuticals other than benzodiazepine ( antidepressants including St John’s wort, anticonvulsants)
    - Current use of antimycotica
    - Allergy for amitriptyline
    - Cardiac arrhythmia / blockade / Long QT syndrome / Brugada syndrome
    - Family history of acute cardiac death
    - Recent myocardial infarction (within the past 90 days)
    - Angina pectoris / coronary insufficiency
    - Severe renal insufficiency (GFR < 10)
    - Severe liver dysfunction
    - Nachtdienstwerker
    - Wens om over the counter slaap hulpmiddelen te blijven gebruiken, zoals cannabis en over the counter melatonine
    - Gebruik van off label amitriptyline in afgelopen jaar
    - Niet de studie instructies kunnen begrijpen en vragenlijsten kunnen invullen (in Nederlands)
    - Dementie
    - Zwangerschap, borstvoeding of wens om zwanger te worden in komende 6 maanden
    - Terminale ziekte (prognose < 1 jaar)
    - Suïciderisico
    - Epilepsie
    - Oculaire hypertensie
    - Aanwezigheid van een ernstige psychiatrische aandoening niet in remissie of adequaat behandeld
    - Huidig alcohol/drugs misbruik of verslaving (met uitzondering van benzodiazepinen)
    - Deelname aan een andere wetenschappelijke studie
    - Huidig gebruik van psychofarmaca uitgezonderd benzodiazepinen
    - Huidig gebruik van antimycotica
    - Allergie voor amitriptyline
    - Cardiale arrhytmia / blockade / verlegd QT syndroom / Brugada syndroom
    - Familie geschiedenis van acuut cardiaal overlijden
    - Recent doorgemaakt myocard infarct (in afgelopen 90 dagen)
    - Angina pectoris / coronaire insufficiëntie
    - Ernstige nier insufficiëntie (GFR < 10)
    - Ernstige lever disfunctie
    E.5 End points
    E.5.1Primary end point(s)
    The main objective of the study is to determine whether low dose amitriptyline (10-20 mg nightly) in chronic insomnia coexisting with medical conditions is as effective as CBT-I in improving subjective sleep.
    De belangrijkste studie-parameter is de gemiddelde subjectieve Insomnie Ernst score, gemeten met de Insomnia Severity index (ISI). Primair eindpunt is bij 12 weken.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 weken
    E.5.2Secondary end point(s)
    Secondary objectives include (1) investigating the long-term efficacy of amitriptyline in comparison to CBT-I, (2) determining the effect on daytime symptoms and functioning, (3) determining whether the medication is well tolerated (safe) (4) identifying mediators and moderators of treatment outcome
    Secundaire uitkomstmaten betreffen slaapkwaliteit, gekwantificeerd als slaap efficiëntie en vragenlijsten omtrent klachten en functioneren overdag (vermoeidheid, emotionele klachten, fysiek functioneren, beperkingen in het functioneren). Mogelijke moderatoren zijn pijn, type insomnia, behandelvoorkeur, causale attributies omtrent insomnia, disfunctionele gedachten en houdingen ten aanzien van slap, pre slaap gerelateerde arousal. Tevens worden negatieve gebeurtenissen, en behandelevaluatie (bijwerkingen, withdrawal symptomen en therapietrouw) gemeten.
    E.5.2.1Timepoint(s) of evaluation of this end point
    10 assessments will take place: at baseline, at start treatment, 6, 12 and 14 weeks, and the responders during follow-up (i.e. reduction on ISI <8 until relapse) at 2, 4, 6 , 8 , 10 and 12 months post treatment. A one-week sleep diary is requested at start treatment,12 weeks, and 12 months post treatment.
    10 evaluaties zullen plaatsvinden: op de basislijn, voor de start van de behandeling, bij 3, 6, 12 en 14 weken na de start van de behandelingen. De responders tot terugval vervolgd worden op 2, 4, 6, 8, 10 en 12 maanden post behandeling. Een slaapdagboek van één week wordt ingevuld bij de start van de behandeling, bij 12 weken, en 12 maanden na behandeling.
    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 Yes
    E.6.4Safety No
    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 No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    cognitieve gedragstherapie
    cognitive behavior therapy
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    End of the trial is last visit of the last subject
    Eende van het onderzoek is laatste bezoek van de laatste deelnemer
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 133
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 57
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state190
    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)
    care a usual
    zorg zoals gebruikelijk
    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 Decision2019-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-17
    P. End of Trial
    P.End of Trial StatusOngoing
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