Clinical Trials Register

Summary
EudraCT Number:	2009-011144-19
Sponsor's Protocol Code Number:	12962A
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:	2009-11-05
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

2009-011144-19

A.3

Full title of the trial

A randomised, double-blind, placebo-controlled study to evaluate if rasagiline can improve depressive symptoms and cognitive function in non-demented, idiopathic Parkinson s disease patients.

A.3.2

Name or abbreviated title of the trial where available

ACCORDO

A.4.1

Sponsor's protocol code number

12962A

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

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	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	AZILECT
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	Information not present in EudraCT
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	Rasagiline
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	1
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	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Subjects will be recruited from the Movement Disorders Outpatient Clinics from academic and hospital institutions in Italy. Only subjects with a BDI-IA score > or = 15 at baseline will be enrolled.Subjects have to be under stable treatment with dopaminergic agents at least 4 weeks before baseline.

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10013113

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 evaluate if rasagiline compared to placebo improves depressive symptoms as evaluated by the Beck Depression Inventory (BDI-IA) total score over a treatment period of 12 weeks.

E.2.2

Secondary objectives of the trial

1. To evaluate if rasagiline compared to placebo improves cognitive function, over a treatment period of
12 weeks, in idiopathic Parkinsons disease (PD) subjects. Cognition will be assessed by the use of a
formal neuropsychiatric cognitive test battery: Noun and Verb Naming Tasks (ENPA), Trail Making
Test (Trails A & B), Cognitive Performance Test (CPT), Stroop Test (ST), Clock Drawing Test (CDT),
Rey Auditory Verbal Learning Test (RAVLT), Benton Judgment of Line Orientation Test (BJLOT),
and ReyOsterrieth Complex Figure (ROCF).
2. To evaluate change in quality of life (QOL) following a treatment period of 12 weeks by using the
Parkinson`s Disease Questionnaire (PDQ-39) scale.
3. To evaluate change in apathy following a treatment period of 12 weeks by using the Apathy Scale (AS).
4. To evaluate change in activities of daily living (ADL) and motor function following a treatment period of
12 weeks by using the Unified Parkinsons Disease Rating Scale (UPDRS) scales part II a

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Outpatient, male or female aged ≥ 40 and < 80 years. The subject has a diagnosis of idiopathic PD
according to the United Kingdom Parkinson`s Disease Society brain bank diagnostic criteria for
Parkinsons disease for the clinical diagnosis of PD.
2. Depressive symptoms with a minimum severity of ≥ 15 using the BDI-IA
3. Hoehn and Yahr stage I-III
4. Under stable (4 weeks prior to baseline) dopaminergic treatment without significant motor complication
such as on-off phenomena and/or dyskinesia
5. The subject and/or legal representative and/or impartial witness is/are able to read and understand the
Subject Information Sheet (SIS).
6. The subject and/or legal representative has/have signed the Informed Consent Form (ICF) and if relevant
the impartial witness has co-signed the ICF.
7. If female, must:
− agree not to try to become pregnant during the study (female patients of childbearing potential will
take pregnancy test, using a urine stick), AND
− use adequate contraception (adequate contraception is defined as oral/systemic contraception,
intrauterine device, diaphragm in combination with spermicidal, or condom for male partner in
combination with spermicidal), OR
− have been menopausal for at least 24 months prior to baseline, (OR)
− have been surgically sterilised prior to baseline, OR
− have had a hysterectomy prior to baseline

E.4

Principal exclusion criteria

1. Motor complications such as wearing off and on-off phenomena
2. Mini-Mental State Examination (MMSE) <26, corrected score.
3. Diagnosis of current or history of major depressive episode according to Diagnostic and Statistical Manual
of Mental Disorders-Text Revision (DSM-IV-TR) criteria within 1 year before recruitment into the study
4. Presence of any other neurodegenerative disorder other than PD, based on judgement of investigator
5. Psychotic symptoms, e.g. hallucination and delirium (determined by clinical evaluation)
6. Presence of any unstable or untreated systemic disorder such as diabetes, cardiac failure, or renal failure
7. Use of any prohibited concomitant medication according to according to the timelines provided in
Appendix II
8. Patient who undergone Deep Brain Stimulation surgery
9. Current treatment with antidepressants or history of treatment with antidepressants less than 1 month prior to randomisation
10. Current treatment or history of treatment less than 1 month prior to randomisation, with antipsychotics,
cholinesterase inhibitors, memantine, amantadine, or anticholinergics
11. Current treatment with selegiline or history of treatment with selegiline less than 90 days prior to
randomisation
12. Contraindications according to the current summary of product characteristics (SPC) of rasagiline
13. Dermatological visit cannot be performed or dermatological visit report is not available on the day before the baseline visit
14. Substance use disorder as defined in DSM-IV-TR, within 6 months prior to screening
15. Known hypersensitivity to rasagiline
16. Disease or taking medication that, in the opinion of the investigator, could interfere with the assessments of
safety, tolerability, or efficacy
17. Treated with any investigational medicinal product within 30 days or 5 half lives (whichever is longer)prior to screening
18. Is pregnant or breast-feeding
19. In the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason
20. Known history of Hepatitis B, Hepatitis C and/or HIV positivity
21. Screening AST, ALT or total bilirubin > 3 times the upper limit of normal (ULN)
22. Is a member of the site personnel or their immediate families
23. Is under forced treatment
24. Is in current treatment or was previously treated with rasagiline
25. Has previously participated in a rasagiline study

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy variable will be the change from baseline in BDI-IA total score.

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)

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

Yes

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.8.3

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

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

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

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)	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	No
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 2009-11-05.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Yes
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	136

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

2009-11-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-10-07

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

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