Clinical Trials Register

Summary
EudraCT Number:	2012-003313-34
Sponsor's Protocol Code Number:	SPD489-345
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2013-02-06
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

2012-003313-34

A.3

Full title of the trial

A Phase 3, Multicenter, Open-label, 12-month Extension Safety and Tolerability Study of SPD489 in the Treatment of Adults with Binge Eating Disorder

Studio di estensione di 12 mesi in aperto, di fase III, multicentrico, per valutare la sicurezza e la tollerabilità di SPD489 nel trattamento di pazienti adulti affetti da disturbo da alimentazione incontrollata

A.3.1

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

A study to examine the study drug, SPD489, in adults subjects who are suffering from Binge Eating Disorder

Uno studio per valutare il farmaco SPD489, in pazienti adulti affetti da disturbo da alimentazione incontrollata

A.3.2

Name or abbreviated title of the trial where available

SPD489-345

A.4.1

Sponsor's protocol code number

SPD489-345

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01657019

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	Shire Development LLC
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	Shire Development LLC
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	Shire Pharmaceutical Ltd
B.5.2	Functional name of contact point	Medical Communications
B.5.3	Address:
B.5.3.1	Street Address	Hampshire International Business Park
B.5.3.2	Town/ city	Chineham, Basingstoke
B.5.3.3	Post code	RG24 8EP
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+448000556614
B.5.5	Fax number	+441256894714
B.5.6	E-mail	medinfoglobal@shire.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Vyvanse
D.2.1.1.2	Name of the Marketing Authorisation holder	Shire US Inc
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Lisdexamfetamine dimesylate (LDX)
D.3.2	Product code	SPD489
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	Lisdexamfetamine dimesylate
D.3.9.1	CAS number	608137-32-2
D.3.9.2	Current sponsor code	SPD489
D.3.9.3	Other descriptive name	LISDEXAMFETAMINE DIMESYLATE
D.3.9.4	EV Substance Code	SUB32146
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	30
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	Yes
D.2.1.1.1	Trade name	Vyvanse
D.2.1.1.2	Name of the Marketing Authorisation holder	Shire US Inc
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Lisdexamfetamine dimesylate (LDX)
D.3.2	Product code	SPD489
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	Lisdexamfetamine dimesylate
D.3.9.1	CAS number	608137-32-2
D.3.9.2	Current sponsor code	SPD489
D.3.9.3	Other descriptive name	LISDEXAMFETAMINE DIMESYLATE
D.3.9.4	EV Substance Code	SUB32146
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: 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	Vyvanse
D.2.1.1.2	Name of the Marketing Authorisation holder	Shire US Inc
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Lisdexamfetamine dimesylate (LDX)
D.3.2	Product code	SPD489
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	Lisdexamfetamine dimesylate
D.3.9.1	CAS number	608137-32-2
D.3.9.2	Current sponsor code	SPD489
D.3.9.3	Other descriptive name	LISDEXAMFETAMINE DIMESYLATE
D.3.9.4	EV Substance Code	SUB32146
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	70
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Binge eating disorder is characterized by recurrent, distressing episodes of uncontrolled consumption of large amounts of food (binge eating) without the inappropriate compensatory weight loss behaviors of bulimia nervosa. Though currently listed in the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) appendix as a disorder provided for further study, it has been recommended that BED be formally included as an eating disorder in DSM-V.

il disturbo da alimentazione incontrollata è caratterizzato da episodi ricorrenti angoscianti di consumo incontrollato di grandi quantità di cibo(abbuffate)senza l’inappropriata compensativa perdita di peso caratteristica della bulimia nervosa.Sebbene attualmente elencata nell’appendice del “Diagnostic and Statistical Manual of Mental Disorders-IV(DSM-IV)”come un disturbo contemplato per ulteriori studi, è stato raccomandato che BED sia formalmente incluso come un disturbo dell’alim.nel DSM-V.

E.1.1.1

Medical condition in easily understood language

Binge eating disorder

disturbo da alimentazione incontrollata

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

MedDRA Classification

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 evaluate the long-term safety and tolerability of SPD489 (50 and 70mg/day) for the treatment of BED in adults 18-55 years of age (inclusive at the time of consent for the respective antecedent SPD489 BED trial). Long-term safety will be described using:
1. Occurrence of TEAEs.
2. Response to the Columbia Suicide Severity Rating Scale (C-SSRS).
3. Specific evaluation of blood pressure and pulse, weight and waist circumference, clinical laboratory evaluations, and ECG results.

valutare la sicurezza e la tollerabilità a lungo termine di SPD489 (50 e 70 mg/die) nel trattamento del BED in pazienti adulti di età compresa tra i 18 e i 55 anni compiuti all’epoca del consenso al precedente studio SPD489 sul BED. La sicurezza a lungo termine verrà descritta come segue:
1. Comparsa di eventi avversi correlati al trattamento (TEAE).
2. Risposta alla scala C-SSRS (Columbia-Suicide Severity Rating Scale) sul rischio di suicidio.
3. Analisi specifiche di pressione sanguigna, frequenza cardiaca, peso e circonferenza della vita, valutazione delle analisi di laboratorio e risultati dell’elettrocardiogramma (ECG).

E.2.2

Secondary objectives of the trial

The secondary objectives are to evaluate the effect of SPD489 on the following clinical experience outcomes (including efficacy and quality of life [QoL]):
1. The global impressions of BED improvement as measured by the Clinical Global Impressions of Improvement (CGI-I) scale.
2. The response in binge eating behavior as measured by Eating Disorder Questionnaire (EDE-Q).
3. QoL as measured by the EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L).
Exploratory Objectives:
1. To explore the utilization of healthcare resources in subjects with moderate to severe BED using the Patient Resource Utilization Questionnaire for Binge Eating Disorder (PRUQ BED).
2. To explore the role of additional parameters of interest in the treatment of BED. Potential parameters that may be studied include, but are not limited to, C-reactive protein (CRP), leptin, and ghrelin.

gli obiettivi secondari comprendono la valutazione degli effetti di SPD489 sui seguenti risultati dell’esperienza clinica (inclusa l’efficacia e la qualità della vita [QoL]).
1.Impressione globale relativa al miglioramento del BED misurata per mezzo della scala dell’impressione clinica globale di miglioramento (CGI-I).2.Risposta a comportamenti di alimentazione incontrollata sulla base del questionario per la valutazione dei disturbi alimentari (EDE-Q).3. Qualità della vita misurata mediante il questionario di autovalutazione EQ-5D-5L (Gruppo EuroQoL,vers.a 5 dimensioni e 5 livelli).Obiettivi esplorativi 1.Utilizzo delle risorse dell’assistenza sanitaria in soggetti affetti da BED da moderato a grave mediante il questionario PRUQ-BED (Patient Resource Utilization Questionnaire for BED).2.Ruolo di eventuali ulteriori parametri di interesse nel trattamento del BED. Potenziali parametri di studio includono, a titolo esempl.,la proteina C-reattiva,la leptina e la grelina.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

The subject cannot be enrolled in the study before all inclusion criteria (including test results) are confirmed.

All subjects must meet the following criteria:

• Subject has completed 1 of the respective antecedent SPD489 BED trials.
• Subject is between 18-55 years of age (or age of majority if greater than 18 years of age, as defined by local regulations), inclusive, at the time of consent from the antecedent trial.
• Subject is able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures.
• Subject has a satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by physical examination findings, clinical laboratory test results, ECG results, or vital sign results that would preclude treatment with SPD489.
• Subject has an understanding, ability, and willingness to fully comply with study related procedures and restrictions.

• Soggetti che hanno completato uno dei rispettivi studi SPD489 precedenti sul BED.
• Soggetti di età compresa tra i 18 e i 55 anni compiuti (o in ogni caso soggetti che hanno raggiunto la maggior età, se superiore ai 18 anni, come prescritto dalle normative locali) al momento del consenso allo studio precedente.
• Soggetti in grado di fornire un consenso informato scritto, firmato e datato, alla partecipazione allo studio prima di effettuare qualsiasi procedura prevista dallo studio.
• Soggetti la cui valutazione medica è risultata soddisfacente e per i quali né l’esame obiettivo, né i risultati delle analisi cliniche di laboratorio, dell’elettrocardiogramma e dei segni vitali hanno evidenziato alcuna anomalia clinica significativa o rilevante che potrebbe precludere il trattamento con SPD489.
• Soggetti disposti a e in grado di comprendere e seguire pienamente le procedure e le restrizioni associate allo studio.

E.4

Principal exclusion criteria

Subjects that have a gap in participation of 30 days or more from completion of the antecedent study Follow-up Visit are excluded from the study if any of the following criteria are met:

• Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa, confirmed by SCID-I Module H.
• Subject has a current comorbid Axis I or Axis II psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms (note: subjects with mild mood or anxiety symptoms that do not meet criteria for Axis I disorder, do not require treatment based on the Investigator’s assessment, and do not confound efficacy or safety assessments in the opinion of the examining Investigator may be included).

Subjects are excluded from the study if any of the following exclusion criteria are met:

• Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
• Subject is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator.
• Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder in accordance with Diagnostic Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Subjects with a lifetime history of amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded. Nicotine dependence is not exclusionary.
• Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant medication.
• Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
• Subjects with a history of moderate to severe hypertension or an average (of 3 readings) resting systolic blood pressure >139mmHg or an average (of 3 readings) diastolic blood pressure >89mmHg at study entry. Note: subjects with mild (Stage 1), well-controlled hypertension on a stable antihypertensive treatment regimen, defined as having maintained the current dose for a period of at least 3 months or more at the time of the Screening Visit (Visit -1) are allowed.
• Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious disease process requiring antibiotics or diabetes), disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Subject will be excluded if he or she has any additional condition(s) that in the Investigator’s opinion would prohibit the subject from completing the study or would not be in the best interest of the subject to participate in the study. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.

I soggetti per i quali sono trascorsi ≥30 dal completamento della precedente visita di follow-up verranno esclusi dallo studio nei seguenti casi:
• Soggetti con sintomi concomitanti di bulimia nervosa o anoressia nervosa come confermato dal modulo H dell’SCID-I.
• Soggetti affetti da comorbidità quali disturbi psichiatrici di asse I o II, controllati mediante l’uso di farmaci vietati nell'ambito del presente studio o non controllati ed associati a sintomi significativi. Nota: potranno essere inclusi nello studio soggetti caratterizzati da lievi sintomi dell’umore o di ansietà insufficienti per una diagnosi del disturbo di asse I e che, secondo lo sperimentatore, non necessitano trattamento, né comportano alcun rischio di inficiare le valutazioni di efficacia o sicurezza.
I soggetti che soddisfino uno qualsiasi dei seguenti criteri di esclusione non potranno prender parte allo studio:
• Soggetti con precedenti di lunga data di psicosi, mania, ipomania, demenza o ADHD.
• Soggetti considerati a rischio di suicidio secondo lo sperimentatore, o soggetti che hanno tentato il suicidio o manifestano al momento ideazioni suicidarie attive. Soggetti con ideazioni suicidarie passive e intermittenti non vanno necessariamente esclusi, sempre sulla base della valutazione dello sperimentatore.
• Soggetti con precedenti recenti (entro gli ultimi sei mesi) di sospetto abuso di stupefacenti o disturbi da dipendenza in accordo con i criteri del DSM-IV-TR. Soggetti con precedenti di lunga data di uso di amfetamine e cocaina, o di abuso e/o di dipendenza da altri stimolanti. La dipendenza da nicotina non è motivo di esclusione.
• Soggetti con precedenti noti di malattia cardiovascolare sintomatica, arteriosclerosi avanzata, anomalia cardiaca strutturale, cardiomiopatia, gravi anomalie del ritmo cardiaco, coronaropatia, o altre patologie cardiache gravi che potrebbero aumentarne la vulnerabilità agli effetti simpatico-mimetici degli stimolanti.
• Soggetti con precedenti familiari noti di morte cardiaca improvvisa o di aritmia ventricolare.
• Soggetti con precedenti di ipertensione moderata o grave o soggetti la cui pressione sistolica media a riposo (su tre letture) è >139 mmHg o la cui pressione diastolica media (su tre letture) è >89 mmHg all’ingresso nello studio (visita 0). Nota: potranno essere inclusi allo studio i soggetti con ipertensione lieve e controllata (stadio 1), che seguono una terapia con un regime di trattamento antiipertensivo stabile, ovvero la cui dose non ha subito modifiche per almeno tre mesi o più alla visita di screening (visita -1).
• Soggetti affetti da patologia concomitante cronica o acuta (ad es. grave rinite allergica, processo infettivo che richiede uso di antibiotici, diabete), disabilità o altra patologia che potrebbe inficiare i risultati della valutazione di sicurezza condotta nel corso dello studio o che potrebbe aumentare i rischi per il soggetto. Soggetti affetti da patologie che, secondo lo sperimentatore, potrebbero compromettere il completamento dello studio da parte del soggetto o rendere nulli i benefici dello stesso. Tali affezioni comprendono malattie gravi o patologie cliniche instabili che potrebbero ostacolare il rispetto del protocollo. Potranno invece essere inclusi pazienti affetti da asma lieve e controllata.

E.5 End points

E.5.1

Primary end point(s)

• The number and percentage of TEAEs
• Response to the C-SSRS
• Specific evaluation of blood pressure and pulse, weight and waist circumference, BMI, clinical laboratory evaluations, and ECG results.

• Numero e percentuale di TEAE
• Risposta alla scala C-SSRS
• Analisi specifiche di pressione sanguigna, frequenza cardiaca, peso e circonferenza della vita, IMC, valutazione delle analisi di laboratorio e risultati dell’elettrocardiogramma (ECG).

E.5.1.1

Timepoint(s) of evaluation of this end point

• TEAEs, C-SSRS, BP/Pulse, Weight: Visits Scr/0-17
• Waist Circumference: Visits Scr/0, 4, 8, 12, 16/ET
• BMI: Visits Scr/0
• Labs: Scr/0, 6, 9, 16/ET
• ECG: Scr/0-4, 8, 12, 16/ET-17

• TEAEs, C-SSRS, BP/Pulse, Weight: Visite Scr/0-17
• Waist Circumference: Visite Scr/0, 4, 8, 12, 16/Fine Studio
• BMI: Visite Scr/0
• Labs: Scr/0, 6, 9, 16/Fine studio
• ECG: Scr/0-4, 8, 12, 16/Fine studio-17

E.5.2

Secondary end point(s)

• CGI-I
• EDE-Q
• EQ-5D-5L

E.5.2.1

Timepoint(s) of evaluation of this end point

• CGI-I: Visits 1- 16/ET
• EDE-Q: Visits 5 – 16/ET
• EQ-5D-5L: Visits 0, 8 and 16/ET

• CGI-I: Visite 1- 16/Fine studio
• EDE-Q: Visite 5 – 16/ Fine studio
• EQ-5D-5L: Visite 0, 8 and 16/ Fine studio

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

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

Yes

E.6.12

Pharmacoeconomic

Yes

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

in aperto, ottimizzazione della dose seguita dal mantenimento della dose

Open-label, Dose Optimization followed by Maintenance

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

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

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

United States

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

The end of the trial is signified by the last patient finishing the last visit (the Follow-up Visit) of the trial.

La conclusione della sperimentazione è definita come l’ultimo paziente che finisce l’ultima visita (visita di follow-up) della sperimentazione.

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:

530

F.1.3

Elderly (>=65 years)

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

160

F.4.2.2

In the whole clinical trial

530

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)

None

Nessuno

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

2013-04-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-02-21

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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