Clinical Trials Register

Summary
EudraCT Number:	2017-001339-38
Sponsor's Protocol Code Number:	17-AVP-786-305
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:	2021-01-27
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

2017-001339-38

A.3

Full title of the trial

A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-design study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer's type

Studio di fase 3, multicentrico, randomizzato, in doppio cieco, controllato con placebo, con disegno parallelo volto a valutare l'efficacia, la sicurezza e la tollerabilità di AVP-786 (destrometorfano bromidrato deuterato [d6-DM]/chinidina solfato [Q]) per il trattamento dell'agitazione in pazienti con demenza di tipo Alzheimer.

A.3.1

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

AVP-786 in the Treatment of Subjects with Agitation Associated with Dementia of the Alzheimer's Type

AVP-786 nel trattamento dei soggetti con agitazione associata a demenza di tipo Alzheimer

A.3.2

Name or abbreviated title of the trial where available

AVP-786 in the Treatment of Subjects with Agitation Associated with Dementia of the Alzheimer's Type

AVP-786 nel trattamento dei soggetti con agitazione associata a demenza di tipo Alzheimer

A.4.1

Sponsor's protocol code number

17-AVP-786-305

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN00000000

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03393520

A.5.3

WHO Universal Trial Reference Number (UTRN)

U0000-0000-0000

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	AVANIR PHARMACEUTICALS, INC.
B.1.3.4	Country	United States
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	Avanir Pharmaceuticals Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Avanir Pharmaceuticals Inc.
B.5.2	Functional name of contact point	Agitation Project Team
B.5.3	Address:
B.5.3.1	Street Address	30 Enterprise, Suite 400
B.5.3.2	Town/ city	Aliso Viejo, California
B.5.3.3	Post code	92656
B.5.3.4	Country	United States
B.5.4	Telephone number	0019492685912
B.5.5	Fax number	0019492422486
B.5.6	E-mail	17.AVP.786.305@avanir.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	No
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	AVP-786 (DESTROMETORFANO BROMIDRATO 18, CHINIDINA SOLFATO 4.9)
D.3.2	Product code	[AVP-786]
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	DESTROMETORFANO BROMIDRATO
D.3.9.1	CAS number	1373497-18-7
D.3.9.2	Current sponsor code	d6-DM
D.3.9.3	Other descriptive name	Deudextromethorphan Hydrobromide
D.3.9.4	EV Substance Code	SUB191183
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	36
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DESTROMETORFANO BROMIDRATO
D.3.9.1	CAS number	1373497-18-7
D.3.9.2	Current sponsor code	d6-DM
D.3.9.3	Other descriptive name	Deudextromethorphan Hydrobromide
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	28
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DESTROMETORFANO BROMIDRATO
D.3.9.1	CAS number	1373497-18-7
D.3.9.2	Current sponsor code	d6-DM
D.3.9.3	Other descriptive name	Deudextromethorphan Hydrobromide
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	42
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CHINIDINA SOLFATO
D.3.9.1	CAS number	6591-63-5
D.3.9.2	Current sponsor code	Q
D.3.9.3	Other descriptive name	QUINIDINE SULFATE DIHYDRATE
D.3.9.4	EV Substance Code	SUB15083MIG
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.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	No
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	AVP-786 (DESTROMETORFANO BROMIDRATO 28, CHINIDINA SOLFATO 4.9)
D.3.2	Product code	[AVP-786]
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	DESTROMETORFANO BROMIDRATO
D.3.9.1	CAS number	1373497-18-7
D.3.9.2	Current sponsor code	d6-DM
D.3.9.3	Other descriptive name	Deudextromethorphan Hydrobromide
D.3.9.4	EV Substance Code	SUB191183
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	56
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CHINIDINA SOLFATO
D.3.9.1	CAS number	6591-63-5
D.3.9.2	Current sponsor code	Q
D.3.9.3	Other descriptive name	QUINIDINE SULFATE DIHYDRATE
D.3.9.4	EV Substance Code	SUB15083MIG
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.IMP: 3
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	No
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	AVP-786 (DESTROMETORFANO BROMIDRATO 42.63, CHINIDINA SOLFATO 4.9)
D.3.2	Product code	[AVP-786]
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	DESTROMETORFANO BROMIDRATO
D.3.9.1	CAS number	1373497-18-7
D.3.9.2	Current sponsor code	d6-DM
D.3.9.3	Other descriptive name	Deudextromethorphan Hydrobromide
D.3.9.4	EV Substance Code	SUB191183
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	85
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CHINIDINA SOLFATO
D.3.9.1	CAS number	6591-63-5
D.3.9.2	Current sponsor code	Q
D.3.9.3	Other descriptive name	QUINIDINE SULFATE DIHYDRATE
D.3.9.4	EV Substance Code	SUB15083MIG
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
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

Agitation Associated with Dementia of the Alzheimer's Type

Agitazione associata a demenza di tipo Alzheimer

E.1.1.1

Medical condition in easily understood language

Agitation behavior associated with Alzheimer's disease

Comportamento caratterizzato da agitazione associata alla malattia di Alzheimer

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	PT
E.1.2	Classification code	10001497
E.1.2	Term	Agitation
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

Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Efficacia, sicurezza e tollerabilità di AVP-786 per il trattamento dell'agitazione in pazienti con demenza di tipo Alzheimer.

E.2.2

Secondary objectives of the trial

None

Nessuno

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Diagnosis of probable AD according to the 2011 NIA-AA working groups criteria.
2. The patient has clinically significant, moderate/severe agitation at the
time of screening and for at least 2 weeks prior to randomization.
3. The diagnosis of agitation must meet the IPA provisional definition of agitation.
4. CGIS-Agitation score is >= 4 (moderately ill) at Screening and Baseline.
5. MMSE score between 6 and 26 (inclusive) at Screening and Baseline.
6. Caregiver must be willing and able to comply with study procedures,including not administering any prohibited medications during the course of the study.

1. Diagnosi di probabile malattia di Alzheimer basata sulle “Linee guida diagnostiche 2011 per la malattia di Alzheimer” emesse dai gruppi di lavoro dell’Istituto nazionale sull’invecchiamento (NIA)-Associazione Alzheimer (AA).
2. Pazienti con agitazione moderata/grave clinicamente significativa al momento dello screening e per almeno 2 settimane prima della randomizzazione.
3. La diagnosi di agitazione deve soddisfare la definizione di agitazione dell’Associazione psicogeriatrica internazionale (IPA).
4. Punteggio >=4 (malattia moderata) nella scala di Impressione clinica globale della gravità della malattia per l’agitazione (CGIS-Agitazione) allo screening e al basale.
5. Punteggio MMSE tra 6 e 26 (compresi) allo screening e al basale.
6. Caregiver affidabile che sia in grado di e disposto ad attenersi alle procedure dello studio, compreso il requisito di non somministrare alcun farmaco proibito durante il corso dello studio.

E.4

Principal exclusion criteria

1. Patient has dementia predominantly of non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia).
2. Patients with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium).
3. Patients with myasthenia gravis (contraindication for quinidine).

1. Pazienti con demenza prevalentemente di tipo non Alzheimer (ad es., demenza vascolare, demenza frontotemporale, malattia di Parkinson, demenza indotta da sostanze).
2. Pazienti con sintomi di agitazione non secondari alla malattia di Alzheimer (ad es., secondari a dolore, altro disturbo psichiatrico o delirio).
3. Pazienti affetti da miastenia gravis (controindicazione per la chinidina).

E.5 End points

E.5.1

Primary end point(s)

Change from Baseline to Week 12 in the composite Cohen-Mansfield Agitation Inventory (CMAI) scores

Variazione dal basale alla Settimana 12 nei punteggi dell’Inventario sull’agitazione di Cohen-Mansfield (CMAI) compositi

E.5.1.1

Timepoint(s) of evaluation of this end point

The CMAI will be assessed at Screening (Day -28 to Day -1), Baseline (Day 1), Day 8 (Visit 2), Day 15 (Visit 2.1), Day 22 (Visit 3), Day 43 (Visit 4), Day 64 (Visit 5), Day 85 (Visit 6), and Follow up visit (for ET patients).

Il CMAI verrà valutato allo screening (dal Giorno -28 al Giorno -1), al basale (Giorno 1), al Giorno 8 (Visita 2), al Giorno 15 (Visita 2.1), al Giorno 22 (Visita 3), al Giorno 43 (Visita 4), al Giorno 64 (Visita 5), al Giorno 85 (Visita 6) e alla Visita di follow-up (per pazienti affetti da trombocitemia essenziale (TE).

E.5.2

Secondary end point(s)

Change from Baseline to Week 12 (Day 85) in the following measures:
Alzheimer's Disease Cooperative Study-Clinical Global Impression of
Change (mADCS-CGIC)-Agitation
Neuropsychiatric Inventory (NPI)
Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain
Alzheimer's Disease Cooperative Study-Clinical Global Impression of
Change (ADCS-CGIC)
Patient Global Impression of Change (PGIC)
Dementia Quality of Life (DEMQOL)
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Resource Utilization in Dementia (RUD)
EuroQol 5-Dimension 5-Level (EQ-5D-5L)

Variazione dal basale alla Settimana 12 (Giorno 85) nelle seguenti misure:
Studio cooperativo sulla malattia di Alzheimer-Impressione clinica globale del cambiamento (mADCS-CGIC)-Agitazione
Inventario neuropsichiatrico (NPI)
Impressione clinica globale della gravit¿ della malattia (CGIS)-Dominio agitazione
Studio cooperativo sulla malattia di Alzheimer-Impressione clinica globale del cambiamento (ADCS-CGIC)
Impressione globale del cambiamento per il paziente (PGIC)
Scala di valutazione della qualit¿ della vita nella demenza (DEMQOL)
Scala di valutazione della malattia di Alzheimer-sottoscala cognitiva (ADAS-Cog)
Utilizzo delle risorse nella demenza (RUD)
Questionario europeo sulla qualit¿ della vita (EuroQol) a 5 dimensioni e 5 livelli (EQ-5D-5L)

E.5.2.1

Timepoint(s) of evaluation of this end point

mADCS-CGIC-Agitation:Day(d) 1,d43(Visit(v) 4),d85(v6 /ET), and Follow-up visit (for ET patients);NPI-Agitation/Aggression domain score
and CaregiverDistress score:Screening (d-28 to d-1),d8 (v2), and d15(v2.1); NPI-AberrantMotorBehaviordomain: (d1),
d22(v3),d43(v4),d64(v5),and d85(v6/ET); NPI-Irritability/Lability domain:(d1),d22 (v3),d43 (v4),d64(v5),and d85(v6/ET);Total NPI:(d1),
d22(v3),d4(v4),d6 (v5),and d85(v6/ET);CGIS-Agitation: Screening (d-28 to d-1),(d1),d43(v4) ,and d85 (v6/ET);ADCS-CGICOverall:(d1),d85(v6/ET);PGIC: d43(v4) and d85(v6/ET); DEMQOL:(d1),
d43 (v4),and d85(v6/ET) for patients withMMSE =10 at the d1;EQ-5D-5L: (d1),d43 (v4),and d85(v6/ET)for patients with MMSE =10;ADAScog:(d1)and d85(v6/ET) forpatients withanMMSEscoreof= 10 at the d1visit;RUD:(d1),d43 (v4),d85(v6/ET)

mADCS-CGIC-Agitazione:d1,d43(v4),d85(v6/TE),visita FU(per pazienti affetti da TE);punteggio relativo al dominio agitazione/aggressivit¿ NPI e punteggio del distress a carico del caregiver:Screening(da d-28 a d-1),d8(v2),d15(v2.1); DominioComportamentoMotorioAberrante NPI:(d1),d22(v3),d43(v4),d64(v5), d85 (v6/TE); Dominio Irritabilit¿/Instabilit¿ NPI:(d1),d22(v3),d43(v4),d64(v5),d85(v6/TE);NPI totale:(d1),d22(v3),d4(v4),d6(v5),d85(v6/TE); CGIS-Agitazione: Screening (da d-28 a d-1),(d1) ,d43(v4),d85(v6/TE);ADCS-CGIC-Generale:(d1),d85(v6/TE);PGIC:d43 (v4),d85(v6/TE); DEMQOL:(d1), d43(v4), d85(v6/TE) per pazienti conMMSE =10 a d1;EQ-5D-5L: d1),d43(v4),d85(v6/TE)per pazienti con MMSE =10;ADAS-cog: (d1)e d85(v6/TE) per pazienti con un punteggio MMSE di=10 a visita d1;RUD: (d1),d43(v4),d85(v6/TE)

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

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

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.8.2.4

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

Yes

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

South Africa

Bulgaria

Czechia

France

Hungary

Italy

Poland

Romania

Spain

United Kingdom

E.8.7

Trial has a data monitoring committee

Yes

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)

Yes

F.1.2.1

Number of subjects for this age range:

103

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

309

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

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

Patients with agitation secondary to dementia of the Alzheimer's type

Pazienti con agitazione secondaria alla demenza di tipo Alzheimer

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

300

F.4.2.2

In the whole clinical trial

412

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)

YES - Patients will have the opportunity to continue treatment and enter into a planned long term extension study.
After a patient has ended the study, usual treatment will be administered.

SI - I pazienti avranno la possibilità di continuare il trattamento e di entrare a far parte di uno studio di estensione programmato a lungo termine. Dopo il completamento dello studio da parte del paziente, gli verrà somministrato il normale trattamento.

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

2018-05-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-03-06

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

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IMP with orphan designation in the indication
Orphan Designation Number:
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