Clinical Trials Register

Summary
EudraCT Number:	2010-018740-13
Sponsor's Protocol Code Number:	acareoxt01
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:	2010-04-08
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

Netherlands - Competent Authority

A.2

EudraCT number

2010-018740-13

A.3

Full title of the trial

Short- and long-term effects of oxytocin on empathy and social behaviour in autistic and antisocial male adults.

A.3.2

Name or abbreviated title of the trial where available

Oxytocin effects in autistic and antisocial male adults

A.4.1

Sponsor's protocol code number

acareoxt01

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	University Medical Center Groningen
B.1.3.4	Country	Netherlands
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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
D.2.1.1.2	Name of the Marketing Authorisation holder	Sigma-Tau BV
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	oxytocin
D.3.4	Pharmaceutical form	Nasal spray*
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intranasal use (Noncurrent)
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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

Antisocial personality disorder
Autism spectrum disorder

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10002822
E.1.2	Term	Antisocial personality disorder

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10063844
E.1.2	Term	Autism spectrum disorder

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To investigate the effectiveness of 4-weeks treatment with intranasally adminsitered oxytocin twice a day versus placebo in improving social behaviour in patients with antisocial personality disorder and in those with autism spectrum disorder

E.2.2

Secondary objectives of the trial

To identify predictors of treatment effectiveness

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. All participants must be male and be in the age range of 18 to 30 years. We decided to investigate only males because the prevalence of both ASD and APD is higher (about 4 times) in males than in females and because sex differences have been found in neuropeptide systems as well as in the processing of socially positive vs. negative information. The choice for investigating males up from the age of 18 is based on the findings that dopamine levels peak in early adolescence and that dopamine has been found to interact with OT expression.
2. All participants must have an IQ of 80 or higher.
3. All participants must have normal or corrected to normal vision.

Additional inclusion criteria for the specific groups:

Participants with ASD:
1. Clinical score on the adult module (V) of the Autism Diagnostic Observation Scale (ADOS). This instrument is a widely accepted and internationally used gold standard for obtaining reliable ASD diagnoses.

Participants with APD:
1. (Previous) DSM-IV diagnosis of an early onset Conduct Disorder.
2. Clinical score on a structured clinical interview for diagnosing DSM-IV axis-II antisocial personality disorders (the SCID-II).
3. A score of 30 or more on the Psychopathy Checklist-Revised (PCL-R) by Hare (1991) which is a semi-structured interview consisting of 20 items to be rated on a 2-point scale by a professional. Yielding a maximum total score of 40, a score of 30 or more is recommended by Hare to identify the prototypical psychopath with a majority of these individuals meeting the criteria for APD. To ensure the inclusion of only highly callous, remorseless individuals in our APD group, we will principally adopt this criterion. If this, however, will result in too a small number of participants left we will lower the criterion.

E.4

Principal exclusion criteria

1. Participants may not have a nasal congestion due to cold or allergies.
2. All participants must be free of psychotropic medication or neuroleptics and stimulant medication. They may not have a history of alcohol or drug dependence.
3. For the empathy experiment, all participants are required to abstain from stimulants, XTC, soft drugs and alcohol for about 20 h, from caffeine for about 4 h and from cigarette smoking and taking food for 2 h before testing. This will, in the first place, rely on informed consent. The use of cocaine, amphetamine, methamphetamine, cannabis and XTC will be controlled for by saliva samples taken before starting the experiment. Blood serum controls will be carried out on the use of methylphenidate and alcohol. Participants who did not abstain for the time of the experiment will be excluded from further participation or data analysis.

E.5 End points

E.5.1

Primary end point(s)

Our primary outcome measures will be social functioning as assessed by (1) the Social Responsiveness Scale (the SRS-A) to be completed by an adult informant who knows the participant in naturalistic social settings and (2) by a symptom checklist to be completed by the participant himself, i.e. the SCL 90 that has been used for treatment studies in forensic settings before.

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

Yes

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

Yes

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)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

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

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

Yes

E.8.2.3

Other

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.8.4.1

Number of sites anticipated in 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

Information not present in EudraCT

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

End of the trial is the last visit of the last subject.

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	No
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	Yes
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	78

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

2010-06-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-08-25

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

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