Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43973   clinical trials with a EudraCT protocol, of which   7311   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-001490-16
    Sponsor's Protocol Code Number:SCÄ01
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-09-14
    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 ConcernedSweden - MPA
    A.2EudraCT number2017-001490-16
    A.3Full title of the trial
    Lisdexamphetamine treatment of Bulimia Nervosa with and without probable simultaneous Attention Deficit Hyperactivity Disorder (ADHD). A randomized , open, fase II-study with cross-over design.
    Lisdexamfetaminbehandling vid Bulimia Nervosa med och utan samtidig sannolik Attention Deficit Hyperactivity Disorder (ADHD). En randomiserad, öppen, fas II- studie med cross-over design.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of Bulimia Nervosa, with and without simultaneous probable ADHD, with the stimulant medicine Lisdexamphetamin .
    Behandling av Bulimia Nervosa, med och utan samtidig sannolik ADHD, med den psykostimulerande medicinen Lisdexamfetamin.
    A.4.1Sponsor's protocol code numberSCÄ01
    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 SponsorStockholms läns landsting
    B.1.3.4CountrySweden
    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 supportStiftelsen Söderström-Königska sjukhemmet, Petrus och Augusta Hedlunds stiftelse
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStockholms centrum för ätstörningar
    B.5.2Functional name of contact pointForsknings- och utvecklingsenheten
    B.5.3 Address:
    B.5.3.1Street AddressWollmar Yxkullsgatan 25
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code11850
    B.5.3.4CountrySweden
    B.5.4Telephone number+46(0)812340000
    B.5.6E-mailnils.erik.svedlund@ki.se
    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 Yes
    D.2.1.1.1Trade name Elvanse vuxen
    D.2.1.1.2Name of the Marketing Authorisation holderSHIRE Pharmaceutical Contracts Limited
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.4Pharmaceutical form Capsule, hard
    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 INNlisdexamfetamine dimesylate
    D.3.9.1CAS number 608137-32-2
    D.3.9.3Other descriptive nameLISDEXAMFETAMINE DIMESYLATE
    D.3.9.4EV Substance CodeSUB32146
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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.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 Yes
    D.2.1.1.1Trade name Elvanse vuxen
    D.2.1.1.2Name of the Marketing Authorisation holderSHIRE Pharmaceutical Contracts Limited
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.4Pharmaceutical form Capsule, hard
    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 INNlisdexamfetamine dimesylate
    D.3.9.1CAS number 608137-32-2
    D.3.9.3Other descriptive nameLISDEXAMFETAMINE DIMESYLATE
    D.3.9.4EV Substance CodeSUB32146
    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 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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Elvanse vuxen
    D.2.1.1.2Name of the Marketing Authorisation holderSHIRE Pharmaceutical Contracts Limited
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.4Pharmaceutical form Capsule, hard
    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 INNlisdexamfetamine dimesylate
    D.3.9.1CAS number 608137-32-2
    D.3.9.3Other descriptive nameLISDEXAMFETAMINE DIMESYLATE
    D.3.9.4EV Substance CodeSUB32146
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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
    Bulimia Nervosa with and without simultaneous Attention Deficit Hyperactivity Disorder.
    Bulimia Nervosa med och utan samtidig Attention Deficit Hyperactivity Disorder.
    E.1.1.1Medical condition in easily understood language
    Bulimia Nervosa with and without simultaneous ADHD
    Bulimia Nervosa med och utan samtidig ADHD
    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
    Will Lisdexamphetamine dimesylate diminish the weekly number of binge eating days in adult females with Bulimia Nervosa.
    Minskar Lisdexamfetamin dimesylat antalet hetsätningsdagar per vecka för vuxna kvinnor med Bulimia Nervosa?
    E.2.2Secondary objectives of the trial
    1. Is the treatment effect from Lisdexamphetamine dimesylate (LDX)on Bulimia Nervosa (BN)-symptoms moderated by the degree of Attention Deficit Hyperactivity Disorder (ADHD) symptoms?
    2. Is the treatment effect from LDX on BN-symptoms dependent on a diagnosis of ADHD at start of study?
    3. Is the treatment effect from LDX on BN-symptoms moderated by the degree of attention deficit problems of ADHD?
    4. Is the treatment effect from LDX on BN-symptoms moderated by the degree of hyperactivity/impulsivity problems of ADHD?
    5. Is self-estimated Eating Disorder symptoms diminished by LDX?
    6. Is global well-being in BN enhanced by LDX?
    7. How is the treatment and the treatment results experienced by the patients?
    1. Modereras behandlingseffekten av Lisdexamfetamin dimesylat (LDX) på Bulimia Nervosa (BN)-symtom av graden av Attention Deficit Hyperactivity Disorder (ADHD)-symtom?
    2. Är behandlingseffekten av LDX på BN-symtom beroende av en ADHD-diagnos vid behandlingsstart?
    3. Modereras behandlingseffekten av LDX på BN-symtom av graden av uppmärksamhetsproblem vid ADHD?
    4. Modereras behandlingseffekten av LDX på BN-symtom av graden av hyperaktivitets-/ impulsivitetsproblem vid ADHD?
    5. Minskar LDX självskattade ätstörningssymtom vid BN?
    6. Förbättrar LDX globalt välbefinnande vid BN?
    7. Hur upplever patienterna behandlingen och behandlingsresultatet?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female.
    2.Bulimia Nervosa according to DSM-5.
    3. Age 18-55 years.
    4. Body mass index 18-45.
    5. At least one weekly binge eating during the two weeks preceding study start.
    6. Acceptance of antikonception.
    7. Signed informed consent to participate in the pharmacological study.
    8. Previous diagnosed ADHD with/without earlier stimulant treatment is not contradictory to inclusion.
    1. Kvinna.
    2. Bulimia Nervosa enligt DSM-5.
    3. 18-55 år.
    4. ”Body mass index” (BMI) 18-45
    5. ≥1 hetsätning per vecka under de 2 veckor som föregår studiestart.
    6. Accepterar antikonception.
    7. Signerat informerat samtycke till att delta i läkemedelsstudien.
    8. Tidigare diagnostiserad ADHD med/utan tidigare centralstimulantiabehandling utgör ej hinder för deltagande.
    E.4Principal exclusion criteria
    1. Pregnancy or nursing.
    2. Known allergy or hypersensitivity to Lisdexamphetamine dimesylate.
    3. Agitation states. Bipolar disease. Psychosis.
    4. Suspected/diagnosed abuse/dependence (nicotine excluded) the last 6 months prior to screen visit. Positiv drug screen. Previous/current abuse of amphetamine, cocaine, other stimulants without time frame.
    5. Mental retardation, Tourette syndrome, serious neurologic disease.
    6. Earlier/current seizure disease, glaucoma, abnormal thyroid function, untreated/unstable high blood pressure, angina pectoris, heart rhythm disturbances or structural heart disease (note heredity for heart/bloodcirculation disease especially occurence of sudden death, heart rhythm disturbances or structural heart disease).
    7. Use of non-permitted pharmaceuticals as listed in the study protocol.
    8. Ongoing medication that has not been well adjusted, effective and taken in the same dose for at least 30 days prior to screen visit.
    9. Diminished kidney or liver function. Low potassium.
    10. Previous suicide attempt, current suicidal thoughts, previous active suicidal thoughts with a plan or intention to act or other suicide risk out from study doctor judgement. If however, after a thorough well documented suicide risk evaluation, it is obvious for the study doctor that the circumstances behind the exclusion out from this paragraph are not relevant for the present situation, the patient can be included. Such a decision and the reasons for it shall be documented in the patients journal and CRF.
    11. Patient treated for depression without an effective and stable treatment since at least 30 days prior to screen visit.
    12. Other obstacles, out from the study doctors judgement, to fulfil the study in a safe manner.
    1. Graviditet eller amning.
    2. Känd allergi eller överkänslighet för Lisdexamfetamin dimesylat.
    3. Agitationstillstånd. Bipolär sjukdom. Psykos.
    4. Misstänkt/diagnosticerat missbruk/beroende (undantaget nikotin) sista 6 månaderna före screeningbesöket. Positiv drogscreening. Tidigare/aktuellt missbruk av amfetamin, kokain, andra stimulantia utan tidsgräns.
    5. Mental retardation, Tourettes syndrom, allvarlig neurologisk sjukdom.
    6. Tidigare/aktuell epilepsi, glaukom, onormal thyroideafunktion, obehandlad/ instabil hypertoni, angina pectoris , hjärtarytmier, eller strukturell hjärtsjukdom (observera hereditet för hjärt-kärlsjukdom, särskilt förekomst av plötslig död, arytmier eller strukturell hjärtsjukdom).
    7. Användande av icke tillåtna läkemedel listade i studieprotokollet.
    8. Pågående medicinering som inte varit välinställd, effektiv och tagits med konstant dos under minst 30 dagar före screeningbesöket.
    9. Nedsatt njurfunktion och nedsatt leverfunktion. Hypokalemi.
    10. Tidigare självmordsförsök, aktuella självmordstankar, tidigare aktiva självmordstankar med plan eller avsikt att agera eller på annan grund av prövaren bedömd självmordsrisk. Om det efter en noggrann väldokumenterad suicidriskbedömning är uppenbart för prövaren att de förhållanden som ligger till grund för exklusion enligt denna punkt inte är relevanta för patientens nuvarande situation kan patienten ändå inkluderas. Ett sådant beslut och grunden för det ska dokumenteras i patientens journal och CRF.
    11. Patient med behandlad depression som inte har en effektiv och stabil behandling sedan 30 dagar före screeningbesöket
    12. Annat hinder enligt prövarens bedömning för att kunna fullfölja studien på ett säkert sätt.
    E.5 End points
    E.5.1Primary end point(s)
    Difference in average number of weekly binge eating days between the last two weeks with only internet treatment and the two last weeks with Lisdexamphetamine dimesylate treatment during the treatment period.
    Skillnad i genomsnittligt antal hetsätningsdagar per vecka mellan sista 2 veckorna med enbart internetbehandling och sista 2 veckorna med LDX-behandling under behandlingsfasen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 8 at week 12.
    Besök 8 vecka 12
    E.5.2Secondary end point(s)
    1. Difference in average weekly number of binge eating days between the two screen-weeks and the two last weeks with Lisdexamphetamine dimesylate (LDX)-treatment in the whole patient group (n=50).
    2. Difference in "Clinical global impression-severity" (CGI-S) from baseline to end of LDX-treatment.
    3. Difference in 3 weeks without symptoms of Bulimia between the last 3 weeks with only internet treatment and the last 3 weeks with LDX-treatment during the treatment phase.
    4. Difference in 1 weeks without symptoms of Bulimia between the last week with only internet treatment and the last week with LDX-treatment during the treatment phase.
    5. Difference in "Eating disorder examination-questionnaire" (EDE-Q) between the initial registration in Riksät and EDE-Q at end of LDX-treatment.
    6. Difference in average weekly binge eating days between the last two weeks with only internet treatment and the last two weeks with LDX-treatment in relation to "Adult self-rating scale for ADHD trait score (ASRSTS).
    7. Difference in average weekly binge eating days between the last two weeks with only internet treatment and the last two weeks with LDX-treatment in relation to "Inattention trait score" (ITS).
    8. Difference in average weekly binge eating days between the last two weeks with only internet treatment and the last two weeks with LDX-treatment in relation to "Hyperactivity trait score" (HTS).
    9. Difference in average weekly binge eating days between the last two weeks with only internet treatment and the last two weeks with LDX-treatment separately for patients with and without ADHD.
    10. Semistructured interview 2 weeks after end of treatment phase.



    1. Skillnad i genomsnittligt antal hetsätningsdagar per vecka mellan screeningveckorna och sista 2 veckorna med LDX-behandling i hela patientgruppen (n=50).
    2. Skillnad i ”Clinical global impression –severity” (CGI-S)(24) från baseline till avslut LDX-behandling.
    3. Skillnad i 3 veckors frihet från bulimisymtom mellan 3 sista veckorna med enbart internetbehandling och 3 sista veckorna med LDX under behandlingsfasen.
    4. Skillnad i 1 veckas frihet från bulimisymtom mellan sista veckan med enbart internetbehandling och sista veckan med LDX under behandlingsfasen.
    5. Skillnad i ”Eating disorder examination-questionnaire” (EDE-Q)(25) mellan initial registrering i Riksät och EDE-Q vid avslut av LDX.
    6. Skillnad i genomsnittligt antal hetsätningsdagar per vecka mellan sista 2 veckorna med enbart internetbehandling och sista 2 veckorna med LDX-behandling i relation till ”Adult self-rating scale for ADHD trait score” (ASRSTS).
    7. Skillnad i genomsnittligt antal hetsätningsdagar per vecka mellan sista 2 veckorna med enbart internetbehandling och sista 2 veckorna med LDX-behandling i relation till ”Inattention trait score” (ITS).
    8. Skillnad i genomsnittligt antal hetsätningsdagar per vecka mellan sista 2 veckorna med enbart internetbehandling och sista 2 veckorna med LDX-behandling i relation till ”Hyperactivity trait score” (HTS).
    9. Skillnad i genomsnittligt antal hetsätningsdagar per vecka mellan sista 2 veckorna med enbart internetbehandling och sista 2 veckorna med LDX-behandling separat för patienter med respektive utan ADHD.
    10. Semistrukturerad intervju 2 veckor efter avslutat behandlingsskede.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2 and 5: Week 6 for the group that starts with Lisdexamphetamine dimesylate and week 12 for the group that starts with only internet treatment.
    3, 4, 6, 7, 8 and 9: Week 12.
    10: Week 14.
    1,2 och 5: Vecka 6 för gruppen som startar med Lisdexamfetamin och vecka 12 för gruppen som startar med enbart internetbehandling.
    3,4,6,7,8 och 9: Vecka 12.
    10: Vecka 14.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.6Cross over Yes
    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
    Enbart internetbehandling utan Lisdexamfetamindimesylat
    Solely internet treatment without Lisdexamphetamine dimesylate
    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
    The end of the trial is defined as the last study visit for the last study subject.
    Prövningens avslutande definieras som sista patientens sista besök.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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: 50
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state50
    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)
    After completion of the study the patient continues with the internet treatment that is a routinely used treatment option at Stockholm centre for Eating Disorders. Evaluation of this treatment and further planning is done together with the internet terapeut after 20 weeks treatment. Participation in the study or premature exit from the study doesn´t influence the internet treatment or other treatment options at Stockholm centre for Eating Disorders.
    Efter studiens avslut fortsätter patienten i internetbehandling som är ett rutinmässigt använt behandlingsalternativ vid Stockholms centrum för ätstörningar. Utvärdering av denna och fortsatt planering görs mellan patienten och internetbehandlaren efter 20 veckors behandling. Deltagande i behandlingsstudien eller förtida avslut av behandlingsstudien påverkar inte internetbehandlingen eller övrigt omhändertagande vid SCÄ.
    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 Decision2017-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-24
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA