Clinical Trials Register

Summary
EudraCT Number:	2019-002997-30
Sponsor's Protocol Code Number:	RA-201902-2017958
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:	2021-10-19
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

2019-002997-30

A.3

Full title of the trial

Dopaminergic Therapy for Frontotemporal Dementia Patients

Effetti della terapia dopaminergica in pazienti con demenza fronto temporale

A.3.1

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

Dopaminergic Therapy for Frontotemporal Dementia Patients

Effetti della terapia dopaminergica in pazienti con demenza fronto temporale

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

RA-201902-2017958

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	I.R.C.C.S. FONDAZIONE S.LUCIA
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	Alzheimer's Drug Discovery Foundation - USA
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	Fondazione Santa Lucia I.R.C.C.S.
B.5.2	Functional name of contact point	Laboratorio di Neuropsicofisiologia
B.5.3	Address:
B.5.3.1	Street Address	Via Ardeatina, 306
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00179
B.5.3.4	Country	Italy
B.5.4	Telephone number	06551501181
B.5.5	Fax number	0651501453
B.5.6	E-mail	g.koch@hsantalucia.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	NEUPRO - 2 MG/24 H + 4 MG/24 H + 6 MG/24 H+ 8 MG/24 H CEROTTO OTTO TRANSDERMICO 7 CEROTTI + 7 CEROTTI + 7 CEROTTI + 7 CEROTTI TRANDERMICI IN BUSTINA
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB MANUFACTURING IRELAND LTD
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	Neupro
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Transdermal patch
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Transdermal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Rotigotina
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Rotigotine
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	4
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	NEUPRO - 2 MG/24 H + 4 MG/24 H + 6 MG/24 H+ 8 MG/24 H CEROTTO OTTO TRANSDERMICO 7 CEROTTI + 7 CEROTTI + 7 CEROTTI + 7 CEROTTI TRANDERMICI IN BUSTINA
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB Pharma S.A. Chemin du Foriest B-1420 Braine l’Alleud Belgio
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	Neupro
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Transdermal patch
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Transdermal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Rotigotina
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Rotigotine
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	2
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	Yes
D.2.1.1.1	Trade name	NEUPRO - 2 MG/24 H + 4 MG/24 H + 6 MG/24 H+ 8 MG/24 H CEROTTO OTTO TRANSDERMICO 7 CEROTTI + 7 CEROTTI + 7 CEROTTI + 7 CEROTTI TRANDERMICI IN BUSTINA
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB MANUFACTURING IRELAND LTD
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	Neupro
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Transdermal patch
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Transdermal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Rotigotina
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Rotigotine
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	6
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
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	Transdermal patch
D.8.4	Route of administration of the placebo	Transdermal use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Transdermal patch
D.8.4	Route of administration of the placebo	Transdermal use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Transdermal patch
D.8.4	Route of administration of the placebo	Transdermal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Frontotemporal Dementia

Demenza fronto-temporale

E.1.1.1

Medical condition in easily understood language

Dementia

Demenza

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	SOC
E.1.2	Classification code	10029205
E.1.2	Term	Nervous system disorders
E.1.2	System Organ Class	10029205 - Nervous system 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

To investigate the potential clinical impact of DA agonists on cognitive and behavioral functions in FTD patients.

Valutare nei pazienti con demenza Fronto-Temporale il potenziale impatto clinico degli agonisti dopaminergici (Rotigotina) sulle funzioni cognitive e comportamentali.

E.2.2

Secondary objectives of the trial

To test if DA agonists treatment changes brain metabolism and brain physiology of FTD patients.

Valutare nei pazienti con demenza Fronto-Temporale le modifiche indotte dalla terapia dopaminergica sul metabolismo cerebrale e sull’attività fisiologica cerebrale.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. The patient has a diagnosis of probable Frontotemporal dementia behavioural variant (bv-FTD) based on the International consensus clinical diagnostic criteria described by Rascovsky et al., 2011.
2. The patient is a man or a woman, aged from 40 to 80 years.
3. The patient has a Clinical Dementia Rating-FTD (CDR-FTD) total score of =2 at Screening.
4. The patient has not been treated with acetylcholinesterase inhibitor (AChEI), i.e., donepezil, galantamine, or rivastigmine, at the time of screening.
5. The patient is able to comply with the study procedures in the view of the investigator.
6. Evidence of frontotemporal hypometabolism at PET imaging.
7. Evidence of amyloid markers excluding Alzheimer’s disease (cerebrospinal fluid Abeta/Tau dosages or amyloid PET imaging).

Tutti i pazienti dovranno avere una diagnosi di probabile demenza Fronto-Temporale variante comportamentale, in base al consenso internazionale dei criteri clinici-diagnostici descritti da Rascovsky et al., 2011.
- I pazienti possono essere uomo o donna, con un’età compresa tra i 40 e gli 80 anni.
- Tutti i pazienti, in seguito ad uno screening, dovranno avere un punteggio totale = 2 nel Clinical Dementia Rating-FTD (CDR-FTD).
- I pazienti, in fase di screening, non sono stati trattati con inibitori dell’Acetilcolinesterasi (AchEI) come Donepezil, Galantamina, Rivastgmina.
- Evidenza di ipometabolismo Fronto-Temporale nelle indagini PET
- Evidenza dei marker di amiloide che escludono la malattia di Alzheimer (dosaggi di Abeta/Tau nel liquido cerebrospinale o Pet amiloide).

E.4

Principal exclusion criteria

1. Significant neurodegenerative disorder of the central nervous system other than FTD e.g., Alzheimer’s disease, Lewy body dementia, Parkinson’s disease, multiple sclerosis, progressive supranuclear palsy, normal pressure hydrocephalus, Huntington’s disease, any condition directly or indirectly caused by Transmissible Spongiform Encephalopathy (TSE), Creutzfeldt-Jakob Disease (CJD), variant Creutzfeldt-Jakob Disease (vCJD), or new variant Creutzfeldt-Jakob Disease (nvCJD)
2. Significant intracranial focal or vascular pathology seen on brain MRI scan within a maximum of 6 months before Baseline leading to a diagnosis other than probable FTD.
3. The patients has history of seizure (with the exception of febrile seizures in childhood).
4. Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MR imaging.
5. Treatment currently or within 3 months before Baseline with any of the following medications: Typical and Atypical antipsychotics (i.e., Clozapine, Olanzapine); Antiepileptics drugs (i.e., Carbamazepine, Primidone, Pregabalin, Gabapentin); Antidepressants (i.e., Citalopram, Duolxetine, Paroxetine).
6.Evidenza di patologie clinicamente significative o scompensate incluse, ma non limitate a patologie polmonari, gastrointestinali, renali, epatiche, endocrine, malattie cardiovascolari o metaboliche. Evidenza di ipotensione ortostatica o disautonomia..
7.Trattamento corrente o entro i 6 mesi precedenti al Baseline con agenti antiparkinsoniani (es L-dopa, dopamino-agonisti, inibitori delle COMT, inibitori delle MAO, farmaci anticolinergici).

Disturbi del Sistema Nervoso Centrale diversi dalla demenza Fronto-Temporale, come malattia di Alzheimer, demenza a corpi di Lewy, Morbo di Parkinson, Paralisi Sopranucleare Progressiva, Sclerosi multipla, Idrocefalo a pressione normale, malattia di Huntington, qualsiasi condizione direttamente o indirettamente causata da encefalopatia spongiforme trasmissibile (TSE), malattia di Creutzfeldt-Jakob (CJD), variante della malattia di Creutzfeldt-Jakob (vCJD) o nuova variante della malattia di Creutzfeldt-Jakob ( nvCJD).
- Presenza di una significativa patologia intracranica o vascolare osservata sulla RMN cerebrale entro un massimo di 6 mesi prima del basale che porta a una diagnosi diversa dal probabile FTD.
- I pazienti hanno una storia di convulsioni (ad eccezione delle convulsioni febbrili nell'infanzia).
- Protesi metalliche nella testa (eccetto quelle dentistiche), pacemaker, impianti cocleari o qualsiasi altro oggetto non rimovibile che sono controindicazioni all'imaging RM.
- Trattamento attualmente o entro 3 mesi prima dela visita basaline con uno qualsiasi dei seguenti farmaci: antipsicotici tipici e atipici (cioè, clozapina, olanzapina); Farmaci antiepilettici (cioè Carbamazepina, Primidone, Pregabalin, Gabapentin); Antidepressivi (cioè Citalopram, Duolxetina, Paroxetina).

E.5 End points

E.5.1

Primary end point(s)

Change from Baseline to Week 24 in the Frontal Assessment Battery (FAB) to evaluate effects of RTG on frontal lobe functions.

Cambiamenti pre-post trattamento (24 settimane) nella “Frontal Assessment Battery” (FAB) per valutare gli effetti della Rotigotina sulle funzioni dei lobi frontali.

E.5.1.1

Timepoint(s) of evaluation of this end point

12 and 24 weeks

12 e 24 settimane

E.5.2

Secondary end point(s)

• Change from Baseline to Week 24 in the Neuropsychiatric Inventory (NPI) scale, to evaluate efficacy of RTG on behavior.
• Change from Baseline to Week 24 in the Clinical Dementia Rating scale-Frontotemporal dementia Sum Of Boxes (CDR-FTDSOB), to evaluate efficacy of RTG on global disease severity.
• Change from Baseline to Week 24 in the Screening for aphasia in Neurodegeneration (SAND) scale, to evaluate efficacy of RTG on language functions.
• Change from Baseline to Week 24 in the Mini Mental State Examination (MMSE), to evaluate efficacy of RTG on global cognition.
• Change from Baseline to Week 24 in the Addenbrooke's Cognitive Examination Revised (ACE-R), to evaluate efficacy of RTG on global cognition.
• Change from Baseline to Week 24 in the Alzheimer's Disease Cooperative Study – Activities of Daily Living (ADCS-ADL): to evaluate efficacy of RTG on activities of daily living.
• Change from baseline to week 24 in 18F-FDG CT/PET, to evaluate the effects of RTG on brain metabolism.
• Change from baseline to week 24 in the SICI, LICI and SAI paired pulse TMS protocols, to evaluate the effects of RTG on synaptic transmission.
• Change from Baseline to Week 24 in the iTBS protocol, to evaluate effects of RTG on cortical plasticity.
• Change from Baseline to Week 24 in the TMS/EEG protocol, to evaluate effects of RTG on DLPFC cortical activity, oscillatory activity and connectivity.
• Nature, frequency and severity of adverse events (AEs): to assess the safety and tolerability of RTG 4mg/day given for up to 24 Weeks.

- Cambiamenti pre-post trattamento (24 settimane) nel “Neuropsychiatric Inventory” (NPI) per valutare gli effetti della Rotigotina sul comportamento.
- cambiamenti pre-post trattamento (24 settimane) nel “Clinical Dementia Rating scale-Frontotemporal dementia Sum Of Boxes” (CDR-FTDSOB) per valutare gli effetti della Rotigotina sulla gravità globale della malattia.
- cambiamenti pre-post trattamento (24 settimane) nel “Screening for aphasia in Neurodegeneration” (SAND) per valutare gli effetti della Rotigotina sul linguaggio.
- cambiamenti pre-post trattamento (24 settimane) nel “Mini Mental State Examination” (MMSE) per valutare gli effetti della Rotigotina sul funzionamento cognitivo globale.
- cambiamenti pre-post trattamento (24 settimane) nel “Addenbrooke's Cognitive Examination Revised” (ACE-R) per valutare gli effetti della Rotigotina sul funzionamento cognitivo globale.
- cambiamenti pre-post trattamento (24 settimane) nel “Alzheimer's Disease Cooperative Study – Activities of Daily Living” (ADCS-ADL) per valutare gli effetti della Rotigotina sulle attività di vita quotidiana.
- cambiamenti pre-post trattamento (24 settimane) nel in 18F-FDG CT/PET, per valutare gli effetti della Rotigotina sul metabolismo cerebrale.
- cambiamenti pre-post trattamento (24 settimane) nei protocolli neurofisiologici SICI, LICI e SAI, per valutare gli effetti della Rotigotina sulla trasmissione sinaptica.
- cambiamenti pre-post trattamento (24 settimane) nel protocollo iTBS, per valutare gli effetti della Rotigotina sulla plasticità corticale.
- cambiamenti pre-post trattamento (24 settimane) nel protocollo TMS-EEG, per valutare gli effetti della Rotigotina sull’attività corticale, sulle oscillazioni corticali e sulla connettività della Corteccia PreFrontale Dorsolaterale (DLPC).
- Natura, frequenza e gravità degli eventi avversi, per valutare la sicurezza e la tollerabilità della Rotigotina ad un dosaggio di 4 mg o 6mg / die somministrati per un massimo di 24 settimane.

E.5.2.1

Timepoint(s) of evaluation of this end point

24 weeks

24 settimane

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

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

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

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

At the end of the 24th week of the last patient

A completamento della 24esima settimana del paziente 75

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:

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)

Plans for treatment or care after a subject has ended his/her participation in the trial. Please specify: (up to 500
characters)(Specificare i programmi per il trattamento o l'assistenza per i soggetti al termine della loro partecipazione allo studio,
in inglese): At the end of experimental procedure (24 weeks from the start of experimental treatment) AD patients will interrupt
the Rotigotine administration and they will continue to take current therapy.

Alla fine della procedura sperimentale (24 settimane dall'inizio del trattamento) i pazienti con demenza fronto-temporale sospenderanno l'assunzione di rotigotina e continueranno la terapia farmacologica di base

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

2021-01-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-02-17

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

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Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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