Clinical Trials Register

Summary
EudraCT Number:	2011-001556-11
Sponsor's Protocol Code Number:	1058
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-03-13
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-001556-11

A.3

Full title of the trial

Decline of mentale functions in adults with Down Syndrome: clinical and experimental study on the effects of treatment with fluoxetine and of cognitive and physical training.

Declino delle funzioni mentali nella sindrome di Down: studio clinico e sperimentale sugli effetti della fluoxetina e di un training psico-fisico.

A.3.1

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

Decline of mentale functions in adults with Down Syndrome: clinical and experimental study on the effects of treatment with fluoxetine and of cognitive and physical training.

Declino delle funzioni mentali nella sindrome di Down: studio clinico e sperimentale sugli effetti della fluoxetina e di un training psico-fisico.

A.4.1

Sponsor's protocol code number

1058

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	IRCCS FONDAZIONE STELLA MARIS
B.1.3.4	Country	Italy
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	Regione Toscana
B.4.2	Country	Italy
B.4.1	Name of organisation providing support	IRCCS FONDAZIONE STELLA MARIS
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	IRCCS Stella Maris
B.5.2	Functional name of contact point	Stefania Bargagna
B.5.3	Address:
B.5.3.1	Street Address	viale del tirreno 331
B.5.3.2	Town/ city	calambrone
B.5.3.3	Post code	56018
B.5.3.4	Country	Italy
B.5.4	Telephone number	050886111
B.5.5	Fax number	050886247
B.5.6	E-mail	sbargagna@inpe.unipi.it

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.2.1.2	Country which granted the Marketing Authorisation	Italy
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	FLUOXETINE
D.3.9.1	CAS number	54910-89-3
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
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	20
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	Yes
D.3.11.13.1	Other medicinal product type	Inibitore selettivo della ricaptazione della serotonina

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

Adults (over 30 years) with Down Syndrome.

Adulti (maggiori di 30 anni) con Sindrome Down.

E.1.1.1

Medical condition in easily understood language

Adults (over 30 years) with Down Syndrome.

Adulti (maggiori di 30 anni) con Sindrome di Down.

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10040442
E.1.2	Term	Severe imbecility
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	SOC
E.1.2	Classification code	10029205
E.1.2	Term	Nervous system disorders
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

The main objective of the project is to determine the effects of environmental enrichment and intervention of fluoxetine after 6 months of the start of the intervention (training or treatment with fluoxetine): i) to prevent cognitive and functional impairment through behavioral tests and questionnaires standardized ii) to change structural neurobiological (brain MRI) and functional (EEG) indices in subjects with DS over 30 years.

L’obiettivo principale del progetto è di determinare gli effetti di un intervento di arricchimento ambientale e della fluoxetina a 6 mesi dall’inizio dello intervento (training o terapia con fluoxetina): i) nel prevenire il deterioramento cognitivo e funzionale attraverso test comportamentali e questionari standardizzati ii) nel modificare indici neurobiologici strutturali (RM encefalo) e funzionali (EEG) in soggetti con SD di età superiore ai 30 anni.

E.2.2

Secondary objectives of the trial

Secondary objectives of the study are: 1. Determine the health and quality of life, through standardized instruments, of adults with DS older than 30 years in Tuscany and to develop a regional database with the data obtained 2. Determine the compliance to the enrichment intervention into the study group and just in case of positive results the treatment protocol will be expanded to all adults with DS in Tuscany.

Gli obiettivi secondari dello studio sono i seguenti: 1. Determinare lo stato di salute e la qualità della vita, attraverso strumenti standardizzati, degli adulti con SD di età superiore ai 30 anni in Toscana e sviluppare un database regionale con i dati ottenuti; 2. Determinare la compliance all’intervento di arricchimento all’interno del gruppo di studio, in modo da valutare la possibilità di espandere il protocollo di trattamento a tutta la popolazione adulta con SD nella regione Toscana in caso di risultati positivi.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion criteria are: 1) SD 2) subjects of both sexes and older than 30 years 3) signing of informed consent by the parent or legal tutor of the patient.

I criteri di inclusione sono: 1) la SD 2) l’età maggiore di 30 anni in soggetti di entrambi i sessi. 3) firma del consenso informato da parte del genitore o tutore legale del paziente.

E.4

Principal exclusion criteria

Exclusion criteria are: 1) the presence of clinical signs of dementia at the first valuation, 2) drugs that may interact with fluoxetine (Monoamine Oxidase, Phenytoin, serotonergic drugs, lithium and tryptophan, oral anticoagulants, Electroconvulsive Therapy, drugs that interact with the CYP2D6 isoenzyme system in the liver), 3) medical conditions that are contraindicated for treatment with fluoxetine (Mania, Hepatic and renal failure, diabetes, Akathisia / psychomotor restlessness, bleeding disorders, epilepsy), 4) established pregnancy (the pregnancy will be investigated in females of childbearing age through the declaration of the person and / or tutor).

I criteri di esclusione sono: 1) la presenza di segni clinici di demenza alla prima valutazione; 2) l’assunzione di farmaci che possono avere interazione con la fluoxetina (Inibitori della Monoamino Ossidasi, Fenitoina, Farmaci serotoninergici, Litio e Triptofano, Anticoagulanti orali, Terapia elettroconvulsiva, farmaci che interagiscono con il sistema isoenzimatico del citocromo CYP2D6 a livello epatico); 3) condizioni cliniche che costituiscono una controindicazione al trattamento con fluoxetina (Mania, Insufficienza epatica e renale, Diabete, Acatisia/irrequietezza psicomotoria, Patologie della coagulazione, Epilessia); 4) accertata gravidanza (lo stato di gravidanza verrà indagato nelle femmine in età fertile attraverso la dichiarazione della persona stessa e/o del tutore).

E.5 End points

E.5.1

Primary end point(s)

Percentual variation of each parameter which has been evaluated.

Variazione percentuale dei singoli parametri valutati.

E.5.1.1

Timepoint(s) of evaluation of this end point

Six months.

Sei mesi

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

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

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

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

in singolo cieco solo per il trainer

Single blinding for the trainer

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

trainig psicofisico

psyco-physical trainig

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.8.4.1

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

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

LVLS

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

Number of subjects for this age range:

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)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

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

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-03-13.

Yes

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Intellectual disabiliy

Disabili intellettivi

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)

At the end of the study, recruited subjects will receive medical assistance according to the protocol for adults with Down syndrome.

Al termine della partecipazione allo studio i soggetti reclutati continueranno a ricevere l’assitenza medica prevista per i soggetti adulti con SD.

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

2011-05-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-05-12

P. End of Trial
P.	End of Trial Status	Completed

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