Clinical Trials Register

Summary
EudraCT Number:	2017-000762-29
Sponsor's Protocol Code Number:	COLAL/11/2016
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:	2021-01-20
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

2017-000762-29

A.3

Full title of the trial

CHOLINA ALPHOSCERATE INJECTION VERSUS CITICOLINE INJECTION IN ELDERLY PATIENTS WITH COGNITIVE IMPAIRMENT RESULTING FROM CEREBROVASCULAR EVENT

STUDIO DI CONFRONTO TRA UNA TERAPIA
A BASE DI COLINA ALFOSCERATO INIETTABILE VERSUS UN REGIME A BASE DI CITICOLINA INIETTABILE IN PAZIENTI ANZIANI CON DEFICIT COGNITIVO CONSEGUENTE AD EVENTO CEREBROVASCOLARE

A.3.1

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

Comparison of choline alphoscerate and citicoline in elderly patients with cognitive disorders of vascular origin

Confronto tra colina alfoscerato e citicolina in pazienti anziani con disturbi cognitivi di origine vascolare

A.3.2

Name or abbreviated title of the trial where available

COMPARISON BETWEEN CHOLINA ALPHOSCERATE AND CITICOLINE IN ELDERLY WITH COGNITIVE IMPAIRMENT OF CEREB

CONFRONTO TRA COLINA ALFOSCERATO E CITICOLINA IN PAZIENTI ANZIANI CON DEFICIT COGNITIVO DI ORIGINE

A.4.1

Sponsor's protocol code number

COLAL/11/2016

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	MDM S.P.A.
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	MDM SPA
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	M.D.M. SPA
B.5.2	Functional name of contact point	Managing Director
B.5.3	Address:
B.5.3.1	Street Address	Via Volturno 29/B
B.5.3.2	Town/ city	Monza
B.5.3.3	Post code	20900
B.5.3.4	Country	Italy
B.5.4	Telephone number	+390393909110
B.5.5	Fax number	+39 039.32.28.88
B.5.6	E-mail	a.maggi@mdmspa.com

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	DELECIT - 5 FIALE SOLUZ INIETT USO IM/EV 1000 MG/4 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	MDM S.P.A.
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.3.1	Product name	Delecit
D.3.2	Product code	025935014
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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	CITICOLIN - 1000 MG/4 ML SOLUZIONE INIETTABILE 5 FIALE 4 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	PIAM FARMACEUTICI S.P.A.
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.3.1	Product name	Citicolin
D.3.2	Product code	024649093
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Cognitive impairment resulting from cerebrovascular event.

Deficit cognitivo conseguente ad evento cerebrovascolare.

E.1.1.1

Medical condition in easily understood language

Cognitive deficit caused by cerebral vascular problems

Disturbo cognitivo causato da un problema vascolare cerebrale

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	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10009846
E.1.2	Term	Cognitive impairment
E.1.2	System Organ Class	100000004852

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10000374
E.1.2	Term	Accident cerebrovascular
E.1.2	System Organ Class	100000004852

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluation of efficacy of the administration of choline alfoscerate injection compared to citicoline injection on global cognitive function.

Valutazione dell¿efficacia della somministrazione di colina alfoscerato iniettabile rispetto alla citicolina iniettabile sulla funzione cognitiva globale.

E.2.2

Secondary objectives of the trial

-Evaluation of efficacy of the administration of choline alfoscerate injection compared to citicoline injection on specific cognitive functions, depression, daily living activity and motor impairment.
-Safety profile of the two study drugs.

-Valutazione dell¿efficacia della somministrazione di colina alfoscerato iniettabile rispetto alla citicolina iniettabile sulle funzioni cognitive specifiche, sulla depressione, sulle attivit¿ quotidiane e sul deficit motorio
-Profilo di sicurezza dei farmaci in studio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Adults male and female aged = 65 years.
•Patients with mild cognitive impairment (MMSE 21-26) post-TIA/stroke
•Subject available for the whole study period and written informed consent obtained prior to enrollement in the study.
•Females infertile according to the following criteria:
• menopausae (amenorrhea of 12 months or more after the conclusion of all the exogenous hormone treatments
• irreversible surgical sterilization documentation (hysterectomy or oophorectomy or bilateral salpingectomy but no tubal ligation).

•Uomini e donne di età = 65
•Pazienti anziani affetti da deficit cognitivo lieve (MMSE tra 21 e 26) post-TIA/ictus
•Soggetto disponibile per tutto il periodo dello studio e consenso informato scritto ottenuto prima dell’inclusione nello studio.
•Donne non fertili secondo uno dei seguenti criteri:
• post-menopausa definita come amenorrea di almeno 12 mesi successiva
alla conclusione di tutti i trattamenti ormonali esogeni;
• documentazione di sterilizzazione chirurgica irreversibile con isterectomia, o ooforectomia bilaterale o salpingectomia bilaterale ma non legatura delle tube.

E.4

Principal exclusion criteria

•Patients with cognitive impairment due to other condition
•Moderate-severe cognitive impairment (MMSE 10-20 or <10)
•Unable to read and/or write
•Evidence of severe or uncontrolled systemic disease or any other significant disorders, which in the opinion of the investigator does not allow the participation in the study or could compromise patient compliance.
•Hypersensitivity to study drugs or excipients.
•History of alcohol or drug abuse.
•Enrollment in another study protocol within 30 days prior to randomization.

•Qualunque altra condizione alla base del deficit cognitivo
•Deficit cognitivo moderato-severo (MMSE tra 10 e 20 e MMSE < 10)
•Pazienti incapaci di leggere o scrivere
•Evidenza di patologie sistemiche gravi o non controllate, che secondo il parere dello sperimentatore non consentono la partecipazione allo studio o potrebbero compromettere la compliance del paziente.
•Storia di ipersensibilità al farmaco o agli eccipienti.
•Arruolamento in un altro studio nei 30 giorni precedenti.
•Storia di abuso di alcol o droghe.
•Qualsiasi altro disturbo che, secondo l’opinione dello sperimentatore, potrebbe influenzare la partecipazione allo studio o i risultati.

E.5 End points

E.5.1

Primary end point(s)

Global cognitive functions assessment:
• Mini Mental State Examination (MMSE)
• Montreal Cognitive Assessment (MoCA)

Valutazione di funzioni cognitive globali:
• Mini Mental State Examination (MMSE)
• Montreal Cognitive Assessment (MoCA)

E.5.1.1

Timepoint(s) of evaluation of this end point

At baseline and after treatment with one of the study drugs for 30 days

Al basale e dopo il trattamento con uno dei farmaci in studio per 30 giorni.

E.5.2

Secondary end point(s)

-Specific cognitive functions assessment:
¿Rey¿s 15 Words Test
¿Verbal memory span
¿ Frontal Assessment Battery (FAB) ; -Depression assessment:
¿Hamilton Psychiatric Rating scale for Depression (HAMD)
¿ Beck Depression Inventory (BDI); -Daily Living assessment:
¿Activities of Daily Living (ADL)
¿Instrumental Activities of Daily Living (IADL); -Motor impairment assessment
¿ Barthel Index
¿Physical Performance Test
¿Medical Research Council Scale for muscle strength ; -Adverse events occurrence.

-Valutazione di alcune funzioni specifiche:
¿ Rey¿s 15 Words Test
¿Verbal memory span
¿ Frontal Assessment Battery (FAB) ; -Valutazione della depressione:
¿ Hamilton Psychiatric Rating scale for Depression (HAMD)
¿Beck Depression Inventory (BDI)
; -Valutazione delle abilit¿ di vita quotidiana:
¿ Activities of Daily Living (ADL)
¿ Instrumental Activities of Daily Living (IADL)
; -Deficit motori (Barthel Index, Physical Performance Test, Scala Medical Research Council della forza muscolare) ; -Insorgenza di eventi avversi

E.5.2.1

Timepoint(s) of evaluation of this end point

At baseline and after treatment with one of the study drugs for 30 days; At baseline and after treatment with one of the study drugs for 30 days
; At baseline and after treatment with one of the study drugs for 30 days; At baseline and after treatment with one of the study drugs for 30 days; Throughout the study

Al basale e dopo il trattamento con uno dei farmaci in studio per 30 giorni.; Al basale e dopo il trattamento con uno dei farmaci in studio per 30 giorni.; Al basale e dopo il trattamento con uno dei farmaci in studio per 30 giorni.; Al basale e dopo il trattamento con uno dei farmaci in studio per 30 giorni.; Per tutta la durata dello studio

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)

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

Yes

E.8.2.2

Placebo

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

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.8.5.1

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

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

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

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

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)

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

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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 patients will be ensured medical care at the same clinical center, in accordance with the timing and procedures required by current clinical practice.

Al termine dello studio ai pazienti partecipanti sar¿ assicurata assistenza medica presso il centro clinico in cui sono stati arruolati, in accordo con le tempistiche e le procedure previste dalla pratica clinica corrente.

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

2017-10-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-09-11

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

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