Clinical Trials Register

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

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A. Protocol Information

A.1

Member State Concerned

Sweden - MPA

A.2

EudraCT number

2017-001490-16

A.3

Full 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.3.1

Title 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.4.1

Sponsor's protocol code number

SCÄ01

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Stockholms läns landsting
B.1.3.4	Country	Sweden
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Stiftelsen Söderström-Königska sjukhemmet, Petrus och Augusta Hedlunds stiftelse
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Stockholms centrum för ätstörningar
B.5.2	Functional name of contact point	Forsknings- och utvecklingsenheten
B.5.3	Address:
B.5.3.1	Street Address	Wollmar Yxkullsgatan 25
B.5.3.2	Town/ city	Stockholm
B.5.3.3	Post code	11850
B.5.3.4	Country	Sweden
B.5.4	Telephone number	+46(0)812340000
B.5.6	E-mail	nils.erik.svedlund@ki.se

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Elvanse vuxen
D.2.1.1.2	Name of the Marketing Authorisation holder	SHIRE Pharmaceutical Contracts Limited
D.2.1.2	Country which granted the Marketing Authorisation	Sweden
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	lisdexamfetamine dimesylate
D.3.9.1	CAS number	608137-32-2
D.3.9.3	Other descriptive name	LISDEXAMFETAMINE DIMESYLATE
D.3.9.4	EV Substance Code	SUB32146
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Elvanse vuxen
D.2.1.1.2	Name of the Marketing Authorisation holder	SHIRE Pharmaceutical Contracts Limited
D.2.1.2	Country which granted the Marketing Authorisation	Sweden
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	lisdexamfetamine dimesylate
D.3.9.1	CAS number	608137-32-2
D.3.9.3	Other descriptive name	LISDEXAMFETAMINE DIMESYLATE
D.3.9.4	EV Substance Code	SUB32146
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Elvanse vuxen
D.2.1.1.2	Name of the Marketing Authorisation holder	SHIRE Pharmaceutical Contracts Limited
D.2.1.2	Country which granted the Marketing Authorisation	Sweden
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	lisdexamfetamine dimesylate
D.3.9.1	CAS number	608137-32-2
D.3.9.3	Other descriptive name	LISDEXAMFETAMINE DIMESYLATE
D.3.9.4	EV Substance Code	SUB32146
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	70
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another 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.1.1

Medical 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.1.1.1

Medical condition in easily understood language

Bulimia Nervosa with and without simultaneous ADHD

Bulimia Nervosa med och utan samtidig ADHD

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary 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.5.1.1

Timepoint(s) of evaluation of this end point

Visit 8 at week 12.

Besök 8 vecka 12

E.5.2

Secondary 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.5.2.1

Timepoint(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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Enbart internetbehandling utan Lisdexamfetamindimesylat

Solely internet treatment without Lisdexamphetamine dimesylate

E.8.2.4

Number of treatment arms in the trial

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

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-11-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-05-24

P. End of Trial
P.	End of Trial Status	Ongoing

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