Clinical Trials Register

Summary
EudraCT Number:	2011-002073-30
Sponsor's Protocol Code Number:	CAFQ056A2222
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:	2012-03-06
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

2011-002073-30

A.3

Full title of the trial

12-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson's disease

Studio in doppio cieco, multicentrico, controllato verso placebo, della durata di 12 settimane, a dose fissa, per valutare l'efficacia e la sicurezza di AFQ056 nella riduzione delle discinesie di grado da moderato a severo indotte da trattamento con L-dopa in pazienti con malattia di Parkinson.

A.3.1

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

Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

Valutazione della efficacia e della sicurezza di AFQ056 nella riduzione delle discinesie indotte da trattamento con L-dopa in pazienti con malattia di Parkinson.

A.4.1

Sponsor's protocol code number

CAFQ056A2222

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01385592

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	NOVARTIS FARMA
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	Novartis
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Farma
B.5.2	Functional name of contact point	Drug Regulatory Affairs
B.5.3	Address:
B.5.3.1	Street Address	Largo Umberto Boccioni, 1
B.5.3.2	Town/ city	Origgio
B.5.3.3	Post code	21040
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 02 96541
B.5.5	Fax number	+39 02 9659066
B.5.6	E-mail	info.studiclinici@novartis.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	AFQ056
D.3.2	Product code	AFQ056
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	NA
D.3.9.1	CAS number	543906-09-8
D.3.9.2	Current sponsor code	AFQ056
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	AFQ056
D.3.2	Product code	AFQ056
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	NA
D.3.9.1	CAS number	543906-09-8
D.3.9.2	Current sponsor code	AFQ056
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	AFQ056
D.3.2	Product code	AFQ056
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	NA
D.3.9.1	CAS number	543906-09-8
D.3.9.2	Current sponsor code	AFQ056
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
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	50
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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: 4
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	AFQ056
D.3.2	Product code	AFQ056
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	NA
D.3.9.1	CAS number	543906-09-8
D.3.9.2	Current sponsor code	AFQ056
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
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	75
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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: 5
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	AFQ056
D.3.2	Product code	AFQ056
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	NA
D.3.9.1	CAS number	543906-09-8
D.3.9.2	Current sponsor code	AFQ056
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
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	100
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

L-dopa induced dyskinesias in patients with Parkinson's disease

L-dopa induce discinesie in pazienti con malattia di Parkinson.

E.1.1.1

Medical condition in easily understood language

Parkinson's Patients With L-dopa Induced Dyskinesias

Pazienti con malattia di Parkinson con discinesie da L-dopa

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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10043118
E.1.2	Term	Tardive dyskinesia
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 assess how titration of AFQ056 at 2-week intervals affects the tolerability profile To demonstrate the anti-dyskinetic efficacy, as measured by the modified AIMS (Abnormal Involuntary Movement Scale) total score

• Valutare come AFQ056, somministrato con dose incrementale ad intervalli di due settimane fino a raggiungere il dosaggio finale di 100 mg b.i.d, influenza il profilo di tollerabilita' in pazienti con PD-LID di grado da moderato a severo rispetto a placebo. • Dimostrare l’efficacia anti-discinetica, misurata come modificazione del punteggio totale della scala AISM (Abnormal Involuntary Movement Scale) alla settimana 12 rispetto al basale, di AFQ056 somministrato con dose incrementale ad intervalli di due settimane fino a raggiungere il dosaggio finale di 100 mg b.i.d rispetto a placebo in pazienti con PD-LID di grado da moderato a severo.

E.2.2

Secondary objectives of the trial

- To assess the anti-dyskinetic efficacy as measured by the Revised Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) - To evaluate change from baseline on patient's disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC) - To evaluate the Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary) - To evaluate anti-dyskinetic efficacy as measured by items 32, 33 and 34 of Part IV of the UPDRS (Unified Parkinson's Disease Rating Scale) - To evaluate the safety of AFQ056 as measured by changes in vital signs, laboratory values and ECGs and number of adverse events Other secondary objectives may be defined in the protocol

• Valutare l’efficacia anti-discinetica sulla base della scala LFADLDS (Revised Lang-Fahn Activities of Daily Living Dyskinesia Scale) compilata dal paziente e dalla persona incaricata alla cura dello stesso • Valutare il cambiamento rispetto al basale della disabilita' legata alla discinesia del paziente sulla base dell’impressione globale della variazione stimata dal clinico (CGIC) • Valutare i periodi ON e OFF totali e il periodo ON con discinesie o discinesie complicate (diario del paziente) • Valutare l’efficacia anti-discinetica sulla base dei parametri 32, 33 e 34 della sezione IV della scala UPDRS (Unified Parkinson’s Disease Rating Scale) • Valutare la sicurezza di AFQ056 sulla base del cambiamento dei segni vitali, dei parametri di ... PER FAVORE VEDERE SINOSSI

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Outpatients with Parkinson`s disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months • Outpatients who are on a stable anti-parkinsonian treatment regimen for at least four weeks Other protocol-defined inclusion criteria may apply

􀁹 Uomini e donne di eta' compresa tra 30 e 80 anni (estremi inclusi) 􀁹 Pazienti ambulatoriali 􀁹 Diagnosi clinica di malattia di Parkinson secondo i criteri diagnostici clinici della UK Parkinson’s Disease Society Brain Bank. 􀁹 Punteggio ≥ 2 al parametro 32 e ≥ 2 al parametro 33 della scala UPDRS. 􀁹 Esordio delle discinesie almeno 3 mesi prima della prima visita basale (BL1) 􀁹 Trattamento stabile con L-dopa e altri trattamenti antiparkinsoniani per almeno 4 settimane prima della prima visita basale (BL1) 􀁹 Dimostrazione di capacita' di completare accuratamente le valutazioni sul diario.

E.4

Principal exclusion criteria

• Surgical treatment for PD • Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated) • Advanced, severe or unstable disease (other than PD) or evidence of dementia that may interfere with the study outcome evaluations Other protocol-defined exclusion criteria may apply

􀁹 Forma atipica o secondaria di malattia di Parkinson 􀁹 Storia di trattamento chirurgico per la malattia di Parkinson, inclusa la stimolazione dei nuclei cerebrali profondi 􀁹 Punteggio = 5 della scala Modified Hoehn and Yahr Staging nella fase ON 􀁹 Qualsiasi malattia avanzata, grave o instabile (oltre alla malattia di Parkinson) 􀁹 Demenza (o MMSE ≤ 26), disturbo depressivo maggiore, allucinazioni o psicosi che richiedano un trattamento antipsicotico, stati confusionali (DSM-IV, revisione) 􀁹 Trattamento precedente alla prima visita basale (BL1) con uno dei seguenti 􀁹 AFQ056 􀁹 Inibitori forti o moderati del CYP3A4 (entro una settimana) 􀁹 Induttori forti o moderati del CYP3A4 (entro una settimana) 􀁹 Warfarin e digossina (entro una settimana) 􀁹 Farmaci anti-colinergici attivi a livello centrale (entro una settimana) 􀁹 Amantadina (entro tre settimane) 􀁹 Metoclopramide (entro quattro settimane) 􀁹 Domperidone, antidepressivi e ansiolitici a regime non stabile (entro sei settimane) 􀁹 Agenti neurolettici tipici o atipici (entro tre mesi) 􀁹 Pompe di duodopa o apomorfina durante l’intera durata dello studio Per maggiori dettagli consultare i paragrafi 4.1 e 4.2 del protocollo originale.

E.5 End points

E.5.1

Primary end point(s)

- Anti-dyskinetic efficacy as measured by the modified AIMS (Abnormal Involuntary Movement Scale) total score - To assess how titration of AFQ056 at 2-week intervals affects tolerability profile

• Dimostrare l’efficacia anti-discinetica, misurata come modificazione del punteggio totale della scala AISM (Abnormal Involuntary Movement Scale) • L’effetto di un lento incremento del dosaggio di AFQ056 sul profilo di tollerabilita'

E.5.1.1

Timepoint(s) of evaluation of this end point

Timeframe 12 weeks

12 settimane

E.5.2

Secondary end point(s)

- Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) - Change from baseline on patient's disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC) - Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary) - Anti-dyskinetic efficacy as measured by items 32, 33 and 34 of Part IV of the Unified Parkinson's Disease Rating Scale (UPDRS ) - Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events

• Valutare l’efficacia anti-discinetica sulla base della scala LFADLDS (Revised Lang-Fahn Activities of Daily Living Dyskinesia Scale) • Valutare il cambiamento rispetto al basale della disabilita' legata alla discinesia del paziente sulla base dell’impressione globale della variazione stimata dal clinico (CGIC) • Valutare i periodi ON e OFF totali e il periodo ON con discinesie o discinesie complicate (diario del paziente) • Valutare l’efficacia anti-discinetica sulla base dei parametri 32, 33 e 34 della sezione IV della scala UPDRS (Unified Parkinson’s Disease Rating Scale) • Valutare la sicurezza di AFQ056 sulla base del cambiamento dei segni vitali, dei parametri di laboratorio, elettrocardiogramma e numero degli eventi avversi

E.5.2.1

Timepoint(s) of evaluation of this end point

- LFADLDS: Weeks -2, 0, 6, 8, 12 - CGIC: Weeks 6, 8, 12 - patient diary: Weeks -2, 0, 8, 12 - UPDRS Part IV:Weeks -6 to -3, -2, 0, 8, 12 - Vital signs: Weeks -6 to -3, -2, 0, 2, 4, 6, 8, 12 - laboratory values: Weeks -6 to -3, -2, 0, 6, 8, 12 - electrocardiogram: Weeks 6 to -3, -2, 6, 8, 12 - Adverse Events: all visits

- LFADLDS: Settimane -2, 0, 6, 8, 12 - CGIC: Settimane 6, 8, 12 - Diario del Paziente: Settimane -2, 0, 8, 12 - UPDRS Part IV:Settimane -6 to -3, -2, 0, 8, 12 - Segni Vitali: Settimane -6 to -3, -2, 0, 2, 4, 6, 8, 12 - Parametri di Laboratorio: Settimane -6 a -3, -2, 0, 6, 8, 12 - elettrocardiograma: Settimane 6 a -3, -2, 6, 8, 12 - Eventi Avversi: tutte le visite

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

tolerability

tollerabilita'

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

Yes

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

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

European Union

Canada

Switzerland

United States

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

LPLV : 06/JULY/2012

LPLV : 06/07/2012

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

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

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

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)

A long-term open-label extension study with AFQ056 will be initiated. Patients who have completed the current study and who meet the inclusion/exclusion criteria for the open-label treatment study will be eligible to enter that study.

Uno studio di estensione in aperto a lungo termine con AFQ056 sarà iniziato. Pazienti che hanno terminato il presente studio e che incontrano i criteri di inclusione/esclusione per lo studio saranno ellegibili per entrare nello studio di estensione.

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

2011-11-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-10-06

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-09-14

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IMP with orphan designation in the indication
Orphan Designation Number:
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