Clinical Trials Register

Summary
EudraCT Number:	2012-003313-34
Sponsor's Protocol Code Number:	SPD489-345
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-03-06
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

Spain - AEMPS

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

Estudio de extensión de fase III, multicéntrico, abierto, de 12 meses de duración para evaluar la seguridad y tolerabilidad de SPD489 en adultos con trastorno por atracón

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

Estudio para evaluar el fármaco del ensayo, SPD489, en sujetos adultos con trastorno por atracón.

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.

El trastorno por atracón se caracteriza por episodios recurrentes y angustiosos de consumo incontrolado de grandes cantidades de alimentos (atracón), sin ir acompañados por la conducta compensatoria para perder peso asociada a la bulimia nerviosa. Aunque actualmente se incluye en el anexo del manual DSM-IV como un trastorno propuesto para estudios posteriores, se ha recomendado que el TPA se incluya formalmente como un trastorno alimentario en el manual DSM-V.

E.1.1.1

Medical condition in easily understood language

Binge eating disorder

Trastorno por atracón

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.

Evaluar la seguridad y tolerabilidad a largo plazo de SPD489 (50 y 70 mg/día) para el tratamiento del TPA en adultos (de entre 18 y 55 años, inclusive, en el momento del consentimiento del anterior estudio sobre el TPA con SPD489). La seguridad a largo plazo se describirá mediante:
1. Aparición de acontecimientos adversos aparecidos durante el tratamiento (AAT).
2. Escala de valoración de gravedad de la conducta suicida de la Universidad de Columbia (C-SSRS)
3. Evaluación específica de la presión arterial y el pulso, el peso y el perímetro de cintura, las evaluaciones de las analíticas clínicas y los resultados del electrocardiograma (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.

Los objetivos secundarios son evaluar el efecto de SPD489 en los siguientes criterios de valoración de la experiencia clínica (incluidas la eficacia y la calidad de vida [CdV]):
1. Impresión de global de la mejoría del TPA, evaluada mediante la Escala de impresión clínica global de la mejoría (CGI-I).
2. La respuesta a la conducta de atracón, evaluada mediante el Cuestionario examen de trastornos de la conducta alimentaria (EDE-Q).
3. CdV según el Cuestionario autoadministrado de 5 niveles y 5 dimensiones del grupo EuroQoL (EQ-5D-5L).
Objetivos exploratorios:
1. Estudiar el uso de los recursos sanitarios en pacientes con TPA moderado o grave, utilizando el Cuestionario de utilización de recursos de pacientes para el trastorno por atracón (PRUQ-BED).
2. Estudiar el papel de parámetros de interés adicionales en el tratamiento del TPA. Los posibles parámetros que pueden estudiarse pueden ser, entre otros, la proteína C-reactiva (PCR), la leptina y 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:

1.-Subject has completed 1 of the respective antecedent SPD489 BED trials.
2.- 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.
3.- Subject is able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures.
4.- 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.
5.- Subject has an understanding, ability, and willingness to fully comply with study related procedures and restrictions.

No se podrá incluir a un paciente en el estudio hasta que no se cumplan todos los criterios de inclusión (incluyendo los resultados de las pruebas): Todos los pacientes deben cumplir los siguientes criterios:
1.- Pacientes que hayan completado uno de los estudios anteriores sobre TPA con SPD489.
2.- Pacientes que tengan entre 18 (o, si las leyes locales fijan la mayoría de edad en una edad superior, la edad a la que se alcance la mayoría) y 55 años de edad, ambos inclusive, en el momento del consentimiento del estudio anterior.
3.- Pacientes capaces de otorgar por escrito, firmar personalmente y fechar el consentimiento informado para participar en el estudio antes de realizar cualquier procedimiento relacionado con el estudio.
4.- Pacientes con una evaluación médica satisfactoria sin anomalías clínicamente significativas o importantes, según los resultados de la exploración física, los análisis clínicos, el ECG o las constantes vitales que impidan el tratamiento con SPD489.
5.- Pacientes que comprendan, puedan y deseen cumplir todos los procedimientos y restricciones relacionados con el estudio.

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:

1.- Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa, confirmed by SCID-I Module H.
2.- 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).
3.- Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
4.- 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.
5.- 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.
6.- 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.
7.- Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
8.- 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.
9.- 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.

Se excluyen a los pacientes que hayan tenido un lapso de participación de 30 días o más en el estudio previo a este de seguimiento y si cumple alguno de los siguientes criterios

1.- El paciente tiene síntomas concomitantes de bulimia nerviosa o anorexia nerviosa, según lo definido en el módulo H de la SCID-I.
2.- Pacientes que padecen un trastorno psiquiátrico asociado del Eje I o del Eje II que está controlado con medicamentos prohibidos en este estudio o no está controlado y se asocia a síntomas significativos (nota: se puede incluir a pacientes con síntomas de trastorno del estado de ánimo o ansiedad leves que no cumplan los criterios para trastornos del Eje I, que no requieran tratamiento según la evaluación del investigador y que no interfieran en las evaluaciones de la eficacia o la seguridad según la opinión del investigador).
3.- Pacientes con antecedentes de psicosis, manía, hipomanía, demencia o trastorno de déficit de atención/hiperactividad.
4.- Pacientes con riesgo de suicidio, en opinión del investigador, que hayan realizado previamente un intento de suicidio o que demuestren ideas suicidas activas. No es necesario excluir a los pacientes con ideas suicidas intermitentes según la evaluación del investigador.
5.- Pacientes con antecedentes recientes (en los últimos 6 meses) de sospecha de abuso de sustancias o trastorno de dependencia, según los criterios del Manual diagnóstico y estadístico de los trastornos mentales, 4.ª edición, texto revisado. Se excluirá a los pacientes con antecedentes de abuso y/o dependencia de anfetaminas, cocaína u otros estimulantes. La dependencia de la nicotina no se considera motivo de exclusión
6.- Pacientes con antecedentes conocidos de enfermedad cardiovascular sintomática, arterioesclerosis avanzada, anomalías cardíacas estructurales, miocardiopatía, anomalías graves del ritmo cardíaco, arteriopatía coronaria u otros problemas cardíacos graves que puedan hacer que se aumente la vulnerabilidad a los efectos simpaticomiméticos de un medicamento estimulante.
7.- Pacientes con antecedentes familiares conocidos de muerte súbita cardíaca o arritmia ventricular.
8.- Pacientes con antecedentes de hipertensión moderada o grave o que tengan una presión arterial sistólica media en sedestación y en descanso (3 lecturas) > 139 mmHg o una presión arterial diastólica media (3 lecturas) > 89 mmHg en la visita de admisión (visita 0). Nota: se permite la inclusión de pacientes con hipertensión leve (nivel 1) bien controlada con una tratamiento antihipertensor estable, definido como el mantenimiento de la dosis actual durante un periodo de al menos 3 meses o más en el momento de la visita de selección (visita -1).
9.- Pacientes con una enfermedad concurrente aguda o crónica (como rinitis alérgica intensa, un proceso infeccioso que requiera antibióticos o diabetes), discapacidad u otras enfermedades que pudieran interferir en los resultados de las evaluaciones de seguridad realizadas en el estudio o que pudieran aumentar el riesgo del paciente. Se excluirá a los pacientes que padezcan alguna otra enfermedad que, en opinión del investigador, impediría al paciente completar el estudio o que haría que la participación en el estudio no fuera lo mejor para el paciente. Esto incluiría, cualquier enfermedad significativa o trastorno médico inestable que pudiera dificultar el cumplimiento del protocolo. El asma leve y estable no se considera un motivo de exclusión.

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.

- Número y porcentaje de AAT.
- Respuesta a la escala C-SSRS
- Evaluación específica de la presión arterial y el pulso, el peso y el perímetro de cintura, el IMC, las evaluaciones de las analíticas clínicas y los resultados del 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

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

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

Abierto, de optimización de dosis seguido de mantenimiento

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.8.3

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.

El final del estudio está definido por la fecha de la última visita del último paciente del ensayo (visita de seguimiento)

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

Ninguno

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

2013-06-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-05-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-10-28

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IMP with orphan designation in the indication
Orphan Designation Number:
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