Clinical Trials Register

Summary
EudraCT Number:	2010-024202-34
Sponsor's Protocol Code Number:	24122010
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-12-09
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

Germany - BfArM

A.2

EudraCT number

2010-024202-34

A.3

Full title of the trial

Effect of oxytocin on therapy results of a group based social skill training in adolescents with Autism Spectrum Disorder

Effekt von Oxytocin auf den Therapieerfolg eines sozialen Kompetenztrainings bei Jugendlichen mit Autismus-Spektrum-Störung

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

group-therapy, autism and oxytocin - an investigation with the question "Does oxytocin (OT) enhance therapy effects in autism?“

Gruppentherapie, Autismus und Oxytocin - Eine Untersuchung, mit der Fragestellung: "Erhöht Oxytocin den Therapieeffekt bei Autisten?"

A.3.2

Name or abbreviated title of the trial where available

group-therapy-autism-oxytocin

Gruppentherapie-Autismus-Oxytocin

A.4.1

Sponsor's protocol code number

24122010

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	UNIVERSITÄTSMEDIZIN GÖTTINGEN, GEORG-AUGUST-UNIVERSITÄT,Klinik für Kinder- und Jugendpsychiatrie/Psychotherapie
B.1.3.4	Country	Germany
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	UNIVERSITÄTSMEDIZIN GÖTTINGEN, GEORG-AUGUST-UNIVERSITÄT, Klinik für Kinder- und Jugendpsychiatrie/Psychotherapie
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters am Zentralinstitut für Seelische Gesundheit
B.5.2	Functional name of contact point	Tanja Schad-Hansjosten
B.5.3	Address:
B.5.3.1	Street Address	J5
B.5.3.2	Town/ city	Mannheim
B.5.3.3	Post code	68159
B.5.3.4	Country	Germany
B.5.4	Telephone number	0049 062117034804
B.5.5	Fax number	0049 062117034805
B.5.6	E-mail	tanja.schad@zi-mannheim.de

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	SyntocinonⓇSpray
D.2.1.1.2	Name of the Marketing Authorisation holder	Defiante Farmaceutica S.A
D.2.1.2	Country which granted the Marketing Authorisation	Austria
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.3.1	Product name	SyntocinonⓇSpray
D.3.2	Product code	11.266
D.3.4	Pharmaceutical form	Nasal spray
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intranasal use (Noncurrent) Nasal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Oxytocin
D.3.9.1	CAS number	50-56-6
D.3.9.4	EV Substance Code	SUB09580MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
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	SyntocinonⓇSpray
D.2.1.1.2	Name of the Marketing Authorisation holder	Alfasigma S.p.A., Italy
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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.3.1	Product name	SyntocinonⓇSpray
D.3.2	Product code	RVG 03716
D.3.4	Pharmaceutical form	Nasal spray
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intranasal use (Noncurrent) Nasal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Oxytocin
D.3.9.1	CAS number	50-56-6
D.3.9.4	EV Substance Code	SUB09580MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Nasal spray
D.8.4	Route of administration of the placebo	Intranasal use (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

high-functioning autismus spectrum disorders: autistic disorder (F84.0), Asperger syndrome (F84.5), atypical autism (F84.1)

Hochfunktionale Autismus-Spektrum-Störung: Frühkindlicher Autismus (F84.0), Asperger-Syndrom (F84.5), Atypischer Autismus (F84.1)

E.1.1.1

Medical condition in easily understood language

autism

Autismus

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10021737
E.1.2	Term	Infantile autism
E.1.2	System Organ Class	100000004873

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The main aim of the study is to investigate if the administration of oxytocin (vs. placebo) facilitates the acquisition of social skills and potentiates the effect of social skill training in patients high-functioning autismus spectrum disorders.

Das Hauptziel ist es zu prüfen, ob die Gabe von Oxytocin (vs. Placebo) bei Patienten mit einer hochfunktionalen Autismus-Spektrum-Störung zu einer verbesserten Lernleistung sozialer Fähigkeiten führt und den Effekt eines Sozialen Kompetenztrainings erhöht

E.2.2

Secondary objectives of the trial

Furthermore we investigate, if the effect of social learning via Oxytocin will be manifest over time.
1. Influence of intranasal applied oxytocin on social interaction, social communication and empathy
2. Influence of intranasal applied oxytocin on mental state and quality of life.

Zudem möchten wir überprüfen, ob sich dieser Lerneffekt über die Zeit manifestiert.
1. Einfluss von Oxytocin auf die soziale Interaktion und soziale Kommunikation und Empathie
2. Einfluss von Oxytocin auf die emotionale Befindlichkeit und Lebensqualität

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Diagnosis of autistic disorder (F84.0 according to ICD-10), Asperger syndrome (F84.5 according to ICD-10), atypical autism (F84.1 according to ICD-10)
male patients
Age 8-18 years
German as native language
no or stable psychopharmacotherapy
signed form of consent (for underage person: legal guardian)

Patienten mit der Diagnose Frühkindlicher Autismus (F84.0 nach ICD-10), Asperger-Syndrom (F84.5 nach ICD-10) und Atypischer Autismus (F84.1 nach ICD-10)
männliches Geschlecht
Alter 8-18 Jahre
gute Deutschkenntnisse
keine oder stabile Psychopharmakotherapie
Einverständniserklärung der Eltern und des Patienten

E.4

Principal exclusion criteria

Female
IQ < 80
traumatic lesions of the brain
obsessive-compulsive disorder
social anxiety disorder
major depression episode with suicidal ideation
aggressive behaviour interfering with group therapy
any personality disorder
serious neurological disease (e.g. epilepsy)
other medical disorder interfering with therapy
group based Social skill training during the last 6 months prior to study
cardiovascular disease
anamnestic known metabolic or endocrinologic disorders
anamnestic known hypersensitivity to nasal sprays or other drugs
within the 2 hours before the application of oxytocin/placebo intake of food, coffee, beverages (except water), nicotin-consumption as well as excessive fluid intake
hypersensitivity to oxytocin
(Safety: At the beginning of the study, each participant will receive OXT/Placebo while being monitored for 90 min by a physician. Participants experiencing serious adverse side effects will be excluded from the study. A trained physician will monitor each group-session)

Weibliches Geschlecht
IQ < 80
Traumatische Hirnverletzungen
Störungen des Sozialverhaltens
Soziale Phobie
schwere Depression mit akuter Suizidalität
aggressives Verhalten, dass mit der Gruppentherapie interferieren könnte
Persönlichkeitsstörung
Schwerwiegende neurologische Erkrankungen (z.B. Epilepsie)
Einnahme von Medikamenten, die mit der Gruppentherapie interferieren könnten
Soziales Kompetenztraining in den letzten 6 Monaten vor Studienbeginn
kardiovaskuläre Erkrankungen
anamnestisch bekannte metabolische oder endokrinologische Erkrankungen
anamnestisch bekannte Überempfindlichkeit gegen Nasensprays oder andere Medikamente
innerhalb der 2 Stunden vor der Verum/ Placebo-Gabe Aufnahme von Nahrung, Kaffee, Getränken (außer Wasser), Nikotin-Konsum sowie exzessives Wassertrinken
Überempfindlichkeit gegenüber Oxytocin
(Vor Studienbeginn erhält jeder Patient unter Beobachtung 90 min eines Mediziner Oxytocin. Bei Nebeneffekten wird der Patient nicht in die Studie eingeschlossen)

E.5 End points

E.5.1

Primary end point(s)

Primary efficacy endpoint:
1. Social interaction and communication behaviour, rated by the parents

1. Soziale Interaktion und Kommunikation

E.5.1.1

Timepoint(s) of evaluation of this end point

baseline assessment
end of intervention
follow-up 3 months
follow-up 6 months

Baseline-Messung (vor der Gruppentherapie)
Ende der Gruppenterapie
Follow-up nach 3 Monaten
Follow-up nach 6 Monaten

E.5.2

Secondary end point(s)

Key secondary endpoint(s):
1. Prosocial behaviour and peer related problems
2. Emotional empathy
3. Depression
4. Psychological distress
5. Quality of life

1. Sozialverhalten und Probleme mit Gleichaltrigen
2. Empathie
3. Depression
4. Stresserleben
5. Lebensqualität

E.5.2.1

Timepoint(s) of evaluation of this end point

baseline assessment
end of intervention
follow-up 3 months
follow-up 6 months

Baseline-Messung (vor der Gruppentherapie)
Ende der Gruppenterapie
Follow-up nach 3 Monaten
Follow-up nach 6 Monaten

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

E.6.4

Safety

E.6.5

Efficacy

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

Yes

E.6.13.1

Other scope of the trial description

cognitive behavioural therapy (group)

kognitive Verhaltenstherapie (Gruppe)

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

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

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

Last Visit of the last patient and data base closure

Letzte Visite des letzten Patienten und Datenbankschluss

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

Yes

F.1.1

Number of subjects for this age range:

210

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

189

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

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

210

F.4.2

For a multinational trial

F.4.2.1

In the EEA

210

F.4.2.2

In the whole clinical trial

210

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)

None

keine

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Klinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Gießen und Marburg
G.4.3.4	Network Country	Germany
G.4 Investigator Network to be involved in the Trial: 2
G.4.1	Name of Organisation	Universitätsklinikum Carl Gustav Carus, Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie, Dresden
G.4.3.4	Network Country	Germany
G.4 Investigator Network to be involved in the Trial: 3
G.4.1	Name of Organisation	UNIVERSITÄTSMEDIZIN GÖTTINGEN, GEORG-AUGUST-UNIVERSITÄT, Klinik für Kinder- und Jugendpsychiatrie/Psychotherapie
G.4.3.4	Network Country	Germany
G.4 Investigator Network to be involved in the Trial: 4
G.4.1	Name of Organisation	Univeritätsklinikum Würzburg, Klinik und Poliklinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie
G.4.3.4	Network Country	Germany
G.4 Investigator Network to be involved in the Trial: 5
G.4.1	Name of Organisation	Zentralinstitut für Seelische Gesundheit, Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters
G.4.3.4	Network Country	Germany

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-04-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-12-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-01-31

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