Clinical Trials Register

Summary
EudraCT Number:	2007-004009-93
Sponsor's Protocol Code Number:	12118A
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:	2008-07-14
Trial results	View 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

2007-004009-93

A.3

Full title of the trial

Prevalence of depression,anxiety and impulse control disorder (ICD) in patients with Parkinson's disease and effectiveness of escitalopram

Prevalenza di depressione, disturbi d'ansia e di controllo degli impulsi in soggetti con malattia di Parkinson ed efficacia di escitalopram

A.4.1

Sponsor's protocol code number

12118A

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	LUNDBECK ITALIA
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	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	CIPRALEX
D.2.1.1.2	Name of the Marketing Authorisation holder	LUNDBECK ITALIA SpA
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	Tablet
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	Escitalopram
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.3	Concentration number	10
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	Non Applicabile
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	CIPRALEX
D.2.1.1.2	Name of the Marketing Authorisation holder	LUNDBECK ITALIA SpA
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	Tablet
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	Escitalopram
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
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	Non Applicabile

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

Depression, anxiety and ICD

disturbo depressivo, d'ansia e disturbo di controllo degli impulsi

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	SOC
E.1.2	Classification code	10037175
E.1.2	Term	Psychiatric disorders
E.1.2	System Organ Class	10037175 - Psychiatric disorders

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 primary objective of the present study is to evaluate the efficacy and safety of escitalopram 10-20 mg/die in depression, anxiety or impulse control disorder (ICD) symptoms in patients suffering from Parkinson disease (efficacy objective) after assessing the prevalence of ICD - anxiety ¿ depression in out-patient Parkinson clinic (epidemiological objective).

L'obiettivo primario dello studio e' valutare l'efficacia e la sicurezza di escitalopram 10-20 mg/die nella depressione, nei disturbi d'ansia e nel disturbo da controllo degli impulsi (ICD) in pazienti con malattia di Parkinson (obiettivo di efficacia) dopo aver valutato la prevalenza di ICD, disturbi d'ansia e depressivi nei pazienti ambulatoriali del centro (obiettivo epidemiologico)

E.2.2

Secondary objectives of the trial

The secondary objectives are: to investigate possible relationship between changes in anxiety symptoms (HAM-A), depressive symptoms (HAM-D, BDI), compulsive behaviour symptoms (PI, SCL-90) and changes in levodopa or dopaminergic drugs self-administration; to evaluate the changes in UPDRS over time, changes in daily off¿time (self-administered with VAS) and changes in ADL (UPDRS-II) and QoL (PDQ-39)

Gli obiettivi secondari sono: valutare le possibili relazioni tra i cambiamenti sintomatologici di ansia (HAM-A),depressione (HAM-D,BDI),comportamenti compulsivi (PI,SCL-90) e le variazioni di autoassunzione di levodopa o farmaci dopaminergici; valutare le variazioni della UPDRS,del tempo in off quotidiano (autovalutato con la VAS) e variazioni della ADL (UPDRS II) e QoL (PDQ-39)

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

LIFE QUALITY:
Vers:
Date:
Title:
Objectives:

QUALITA DELLA VITA:
Vers:
Data:
Titolo:
Obiettivi:

E.3

Principal inclusion criteria

¿ Male or female and aged ≥18 years ¿ Diagnosis of Parkinson Disease according to UK Brain Bank criteria ¿ Diagnosis of major depression, minor depression, anxiety disorder (GAD, SAD, panic disorder) impulse control disorder (ICD) according to DSM IV TR criteria ¿ Current treatment with levodopa and/or dopaminergic agonists orally administered ¿ The daily dose of levodopa and dopaminergic agonist have been stable for at least the last 2 months prior to enrolment ¿ Patients are in stage I-II according to H&Y scale ¿ Patients must have signed the informed consent form to study participation

· firma del consenso informato approvato dal CE · pazienti di sesso maschile e femminile di eta` superiore a 18 · diagnosi di malattia di Parkinson secondo i criteri ¿UK Brain bank¿ · diagnosi di disturbo depressivo o ansia o disturbo del controllo degli impulsi in accordo ai criteri DSM IV TR · pazienti attualmente in trattamento con levodopa e/o dopamino-agonisti somministrati oralmente · la dose giornaliera della levodopa e dopamino-agonisti e` stata stabile negli ultimi 2 mesi prima dell¿arruolamento · punteggio I-III secondo la scala H&Y

E.4

Principal exclusion criteria

1. The patient has a terminal illness or a severe general medical condition or has a positive HIV test at entry¿. 2. The patient is suffering from a neurological or psychiatric disease other than PD or affective disorder 3. The patient has concomitant, moderate to severe dementia (MMSE 20) 4. The patient has any condition that could impose hazards to the patient (including suicidal risk) if study therapy is initiated, or affect the participation of the patient in the study. The judgment is left to the discretion of the investigator. 5. The patient is a woman with any childbirth potential 6. The patient is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason 7. The patient has been treated with any investigational medicinal product within 30 days or 5 half lives (whichever is longer) prior to screening 8. The patient is currently treated with non selective I-MAO or moclobemide (selective reversible MAO-A) or has been treated with non selective I-MAO or moclobemide within 14 days prior to enrolment. 9. The patient has a history of lack of response to escitalopram 10. The patient has a history of severe drug allergy or hypersensitivity to escitalopram or any of product components within 30 days or 5 half lives (whichever is longer) prior to screening ¿ The patient is currently treated with non selective I-MAO or have been treated with non selective I-MAO within 14 days prior to enrolment. ¿ The patient has a history of lack of response to escitalopram ¿ The patient has a history of severe drug allergy or hypersensitivity to escitalopram or any of product components

· il paziente e` affetto da una malattia terminale o da condizioni mediche generali critiche · il paziente soffre di altre malattie neurologiche o psichiatriche oltre al morbo di Parkinson · il paziente e` affetto da concomitante demenza moderata o severa (MMSE ≤ 20) · il paziente ha una condizione tale che potrebbe causale rischi (incluso rischio di suicidio) in seguito all¿assunzione del farmaco in studio, o potrebbe influenzare la partecipazione del paziente allo studio · la paziente ha un test di gravidanza (βHCG serico positivo o test di gravidanza delle urine o evidenza clinica) positivo o sta allattando · il paziente, secondo giudizio dello sperimentatore, non e` in grado di soddisfare i requisiti del protocollo · il paziente e` stato trattato con un farmaco sperimentale negli ultimi 30 giorni prima dello screening · il paziente e` attualmente in trattamento con inibitori non selettivi MAO o e` stato trattato con inibitori non selettivi MAO negli ultimi 14 giorni · il paziente ha evidenza di mancata risposta ad escitalopram · il paziente ha storia di severa allergia o ipersensibilita` ad escitalopram o a qualsiasi altro componente del prodotto

E.5 End points

E.5.1

Primary end point(s)

Primary variables: The primary efficacy assessments will be based on the following evaluation tools for each diagnostic group: Depression: HAM-D Anxiety: HAM-A ICD: PI Primary end point will be the change from baseline of reference scale for each diagnostic group

Depressione: HAM-D Ansia: HAM-A ICD: BIS End-point primario sara` la variazione delle scale di riferimento per ciascun gruppo rispetto al basale

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

in aperto

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

Information not present in EudraCT

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 study is defined as the last protocol-specified contact with a 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

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.1.3

Elderly (>=65 years)

Yes

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

Yes

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.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)

nessuno

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

2008-05-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-04-01

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

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