Clinical Trials Register

Summary
EudraCT Number:	2017-000990-35
Sponsor's Protocol Code Number:	FARM12.PW7R_A6-DeprEpil
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-01-14
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

2017-000990-35

A.3

Full title of the trial

EFFECTS OF ANTIDEPRESSANT TREATMENT WITH AGOMELATINE ON PATIENTS AFFECTED BY DEPRESSION AND EPILEPSY. A DOUBLE BLIND RANDOMIZED STUDY WITH ACTIVE CONTROL (ESCITALOPRAM) WITH PARALLEL GROUPS.

A.3.1

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

Effects of the antidepressive therapy with Agomelatin and Escitalopram in people with depression and epilepsy

Effetti della terapia antidepressiva utilizzando Agomelatina ed Escitalopram in persone con depressione ed epilessia

A.3.2

Name or abbreviated title of the trial where available

DeprEpil

A.4.1

Sponsor's protocol code number

FARM12.PW7R_A6-DeprEpil

A.5.4

Other Identifiers

Name:

n.a.

Number:

n.a.

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	DIP. MEDICINA DEI SISTEMI UNIVERSITà DEGLI STUDI DI ROMA TOR VERGATA
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
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	Link Neuroscience and health care s.r.l. - L.N.Age s.r.l.
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Via Luigi Rizzo 62
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00136
B.5.3.4	Country	Italy
B.5.4	Telephone number	0639746749
B.5.5	Fax number	0683962771
B.5.6	E-mail	info@lnage.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.2.1.1.1	Trade name	VALDOXAN - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (ALU/PVC) 7 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	LES LABORATOIRES SERVIER
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	Agomelatina
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	n.a.
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	25
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	Comparator
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	ESCITALOPRAM ACCORD - " 10 MG COMPRESSE RIVESTITE CON FILM " 98 COMPRESSE IN BLISTER AL/AL
D.2.1.1.2	Name of the Marketing Authorisation holder	ACCORD HEALTHCARE LIMITED
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	Escitalopram
D.3.2	Product code	n.a.
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	n.a.
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	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	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

Depression in patients affected by epilepsy

Depressione in pazienti affetti da epilessia

E.1.1.1

Medical condition in easily understood language

Depression in person with epilepsy

Depressione in persone con epilessia

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10032061
E.1.2	Term	Other forms of epilepsy
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

The primary objective of this study is to evaluate the effects of AGO on depressive symptoms of PWE as compared to escitalopram as active control.

L’obiettivo primario di questo studio è la valutazione dell’effetto dell’Agomelatina sui sintomi depressivi nelle persone affette da epilessia comparato all’Escitalopram come controllo attivo.

E.2.2

Secondary objectives of the trial

• To evaluate the quality of life and seizure frequency in order to test the actual relationship between depressive symptoms and seizure control and to test the hypothesis of a “melatoninergic” additive effect of AGO on depression and seizures frequency when compared to escitalopram as active control;
• To evaluate the effects of AGO on subjective sleep quality as compared to escitalopram;
• To evaluate the effects of AGO on excessive daytime somnolence as compared to escitalopram;
• To evaluate the effects of AGO on cognition as compared to escitalopram.

• Valutare la qualità della vita e la frequenza delle crisi per testare l'effettiva relazione tra sintomi depressivi e controllo delle crisi e testare l'ipotesi di un effetto additivo "melatoninergico" di AGO sulla depressione e sulla frequenza di crisi rispetto all'escitalopram come controllo attivo;
• Valutare gli effetti di AGO sulla qualità del sonno soggettiva comparato ad Escitalopram;
• Valutare gli effetti di AGO sull’eccessiva sonnolenza diurna comparato con Escitalopram;
• Valutare gli effetti di AGO sulla cognizione comparato con Escitalopram.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Definite diagnosis of epilepsy and antiepileptic medication for more than 6 months;
2. Age 40-75;
3. Beck Depression Inventory –II score >14
4. No previous utilization of any antidepressant agent;
5. Able to co-operate and understand written and oral information;
6. Signed written informed consent.

1. Diagnosi conclamata di epilessia e assunzione di farmaci antiepilettici per più di 6 mesi;
2. Età compresa tra 40 e 75 anni;
3. Punteggio> 14 nella “Beck Depression Inventory”;
4. Nessun precedente trattamento antidepressivo utilizzato;
5. Capacità di cooperazione e comprensione di informazioni scritte e orali;
6. Consenso Informato scritto.

E.4

Principal exclusion criteria

1. Patients with hypersensitivity to the Agomelatine and/or Escitalopram;
2. Psychiatric disorders other than depression;
3. Participation in other clinical trials within the last six months prior to inclusion in the present study;
4. Unable to take part in the study as a whole;
5. Use of drugs interfering with CNS other than AEDs;
6. History of pseudoseizures, status epilepticus during the previous year;
7. Alterations of blood tests that might interfere with the participation and/or completion of the study by the patient;
8. Patients with hepatic injury, or with transaminases levels three times the upper limit of normal (ULN), or hepatic risk factors such as obesity/overweight/non-alcoholic fatty liver disease, diabetes, substantial alcohol intake or concomitant medicinal products associated with risk of hepatic injury.
9. Concomitant treatment based on strong CYP1A2 inhibitors;
10. Women of childbearing potential who are not using effective contraception;
11. Women with suspected or confirmed pregnancy and breastfeeding;
12. Concomitant hormonal therapy;
13. QTc interval>450 msec.

1. Pazienti con ipersensibilità ad AGO e/o Escitalopram;
2. Disturbi psichiatrici diversi dalla depressione;
3. Partecipazione ad altre sperimentazioni cliniche negli ultimi sei mesi antecedenti la partecipazione al presente studio;
4. Incapacità di prendere parte allo studio nel suo complesso;
5. Utilizzo concomitante di farmaci, diversi da quelli epilettici, che possono interferire con il SNC;
6. Storia di pseudo-crisi convulsive, stato epilettico durante l'anno precedente;
7. Le alterazioni degli esami del sangue che potrebbero interferire con la partecipazione e/o il completamento dello studio da parte del paziente;
8. I pazienti con danno epatico, o con valori delle transaminasi tre volte più alto il limite superiore, o con fattori di rischio epatici, per esempio, obesità/ sovrappeso/malattia non alcolica del fegato grasso, il diabete, sostanziale assunzione di alcol o medicinali concomitanti associati al rischio di danno epatico;
9. Uso concomitante con forti inibitori del CYP1A2;
10. Le donne in età fertile che non utilizzano un contraccettivo efficace;
11. Donne con sospetta o confermata gravidanza o allattamento;
12. Presenza di terapie ormonali concomitanti;
13. Intervallo QTc > 450 msec.

E.5 End points

E.5.1

Primary end point(s)

Efficacy (Depression BDI-II)

Efficacia (Depressione BDI-II)

E.5.1.1

Timepoint(s) of evaluation of this end point

30 months

30 mesi

E.5.2

Secondary end point(s)

Depression (HDRS), Quality of life (Qolie-31P, Quality of Life in Epilepsy II Version), Sleep quality (PSQI), daytime sleepiness (ESS) and cognition (MDB).

Depressione (HDRS), Qualità della vita (Qolie-31P, Quality of Life in Epilepsy II Version), Qualità del sonno (PSQI), sonnolenza giornaliera (ESS) e capacità cognitive (MDB).

E.5.2.1

Timepoint(s) of evaluation of this end point

30 months

30 mesi

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

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)

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

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.8.5.1

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

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

134

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

Information not present in EudraCT

F.3.3.2

Women of child-bearing potential using contraception

Information not present in EudraCT

F.3.3.3

Pregnant women

Information not present in EudraCT

F.3.3.4

Nursing women

Information not present in EudraCT

F.3.3.5

Emergency situation

Information not present in EudraCT

F.3.3.6

Subjects incapable of giving consent personally

Information not present in EudraCT

F.3.3.7

Others

Information not present in EudraCT

F.4 Planned number of subjects to be included

F.4.1

In the member state

208

F.4.2

For a multinational trial

F.4.2.1

In the EEA

208

F.4.2.2

In the whole clinical trial

208

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 Clinical Trial the PI will decide if the patient can continue the therapy or not.

Al termine dello Studio è a discrezione del medico la decisione di far continuare o meno al paziente la terapia sottopostagli durante lo Studio

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

2018-05-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-02-06

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

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