Clinical Trials Register

Summary
EudraCT Number:	2011-003006-25
Sponsor's Protocol Code Number:	SPD489-323
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-11-22
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Poland - Office for Medicinal Products

A.2

EudraCT number

2011-003006-25

A.3

Full title of the trial

The SPD489-323, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination with an Antidepressant in the Treatment of Adults with Major Depressive Disorder with Inadequate Response to Prospective Treatment with an Antidepressant.

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 subjects with major depressive disorder (MDD) who are taking certain types of antidepressants and continuing to have MDD symptoms.

A.3.2

Name or abbreviated title of the trial where available

SPD489-323

A.4.1

Sponsor's protocol code number

SPD489-323

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 Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Shire Development Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Shire Pharmaceuticals 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, Hampshire
B.5.3.3	Post code	RG24 8EP
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+440800 0556614
B.5.5	Fax number	+4401256894714
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	608137-33-3
D.3.9.2	Current sponsor code	SPD489
D.3.9.3	Other descriptive name	NRP104
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	20
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	608137-33-3
D.3.9.2	Current sponsor code	SPD489
D.3.9.3	Other descriptive name	NRP104
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: 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	608137-33-3
D.3.9.2	Current sponsor code	SPD489
D.3.9.3	Other descriptive name	NRP104
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	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	608137-33-3
D.3.9.2	Current sponsor code	SPD489
D.3.9.3	Other descriptive name	NRP104
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
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
D.8 Placebo: 2
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
D.8 Placebo: 3
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
D.8 Placebo: 4
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

Major Depressive Disorder

E.1.1.1

Medical condition in easily understood language

Depression

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

The primary objective is to demonstrate the efficacy of SPD489 when used as augmentation therapy in the treatment of major depressive disorder (MDD) in inadequate responders following an 8-week course of treatment with an antidepressant, as measured by the mean change in Montgomery-Ǻsberg Depression Rating Scale (MADRS) total scores.

E.2.2

Secondary objectives of the trial

The key secondary objective is to demonstrate the effect of SPD489, when used as augmentation therapy in the treatment of MDD in inadequate responders following an 8-week course of treatment with an antidepressant, on quality of life (QoL) as measured by the Sheehan Disability Scale (SDS).

Additional secondary objectives are described in the Protocol.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subject has a primary diagnosis of non-psychotic major depressive disorder (single or recurrent) as defined by the Structured Clinical Interview for DSM-IV-TR disorders – Axis-I (SCID-CT) that has lasted ≥8 weeks prior to the Screening Visit (Visit 1).

Subject has a Montgomery Asburg Depression Rating Scale (MADRS) total score ≥24 at the Lead-in Baseline Visit (Visit 2).

E.4

Principal exclusion criteria

- Subject whose current episode of MDD has not responded to an adequate treatment regimen (at least 6 weeks of treatment at the maximum tolerated adult dose approved for the indication) with 2 or more approved single antidepressant agents. Any subject whose current episode of MDD has not responded to an approved adjunctive treatment strategy is to be excluded.

- Subject who has a lifetime history of treatment-resistant depression, defined as having not responded to adequate treatment (at least 8 weeks of treatment at the maximum tolerated adult dose approved for the indication) with 2 or more treatment regimens, including, distinct classes of approved single antidepressant agents and adjunctive treatment strategies.

- Subject is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt within the past 3 years, or is currently demonstrating active suicidal ideation.

- Subject has any current co-morbid psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms. Excluded are: any significant Axis II disorders, any bipolar disorder, any current or lifetime psychosis, post-traumatic stress disorder, anorexia nervosa, and bulimia nervosa.

A history of serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant medication, a history of moderate to severe hypertension or an average (of 3 readings) resting sitting systolic blood pressure >139mmHg or an average (of 3 readings) diastolic blood pressure >89mmHg at the Screening Visit (Visit 1) and/or Lead-in Baseline Visit (Visit 2), or a concurrent chronic or acute illness or unstable medical condition that may deteriorate that could confound the results of safety assessments, increase risk to the subject, or lead to difficulty complying with the protocol.

E.5 End points

E.5.1

Primary end point(s)

Change from Augmentation Baseline Visit (Visit 8 [Week 8]) to Visit 14 (Week 16/Any) in Montgomery-Asberg Depression Rating Scale (MADRS) total score.

E.5.1.1

Timepoint(s) of evaluation of this end point

• Randomized Subjects: Week -4 to -1, 0, 6, 8, 9, 10, 11, 12, 14, 16/Any
• Non-Randomized Subjects: Week -4 to -1, 0, 6, 8, 10, 12, 16/Any

E.5.2

Secondary end point(s)

1) Change from the Augmentation Baseline Visit (Visit 8 [Week 8]) to Visit 14 (Week 16/Any) in Sheehan Disabillity Scale (SDS) total score.
2) Safety and tolerability as based on a) occurrence of treatment-emergent adverse events (TEAEs), b) response to Columbia Suicide Severity Rating Scale (C-SSRS), evaluations of blood pressure and pulse, c) clinical laboratory evalutions, and d) electrocardiograms (ECG)
3) Percent of Participants Achieving a 25% Response on the MADRS at Visit 14 (Week 16/Any)
4) Percent of Participants Achieving a 50% Response on the MADRS at Visit 14 (Week 16/Any)
5) Percent of Participants Achieving Remission on the MADRS at Visit 14 (Week 16/Any)
6) Change from Augmentation Baseline Visit (Visit 8 [Week 8]) over time in MADRS total score.
7) Change in Abbreviated Brief Assessment of Cognition Affective Disorders (ABAC-A)
8) Change from the Augmentation Baseline Visit (Visit 8 [Week 8]) to Visit 14 (Week 16/Any) in Short Form-12 Health Survey V2 (SF-12V2)
9) Change from the Augmentation Baseline Visit (Visit 8 [Week 8]) to Visit 14 (Week 16/Any) in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L index score)
10) Change from the Augmentation Baseline Visit (Visit 8 [Week 8]) to Visit 14 (Week 16/Any) in Changes in Sexual Functioning Questionnaire - 14 item Scale (CSFQ-14)
11) Clinical Global Impressions - Severity of Illness (CGI-S) at Visit 2 (Week 0) and Visit 8 (Week 8)
12) Change in Clinical Global Impressions - Global Improvement (CGI-I) at Visit 14 (Week 16/Any)
13) Change from the Augmentation Baseline Visit (Visit 8 [Week 8]) to Visit 14 (Week 16/Any) in Global Fatigue Index (GFI) in the Multidimensional Assessment of Fatigue (MAF)
14) Amphetamine Cessation Symptom Assessment (ACSA) at Visit 15 (Week 17/Any)

E.5.2.1

Timepoint(s) of evaluation of this end point

1 )
• Randomized (R): Week (Wk) 0, 8, 9, 10, 11, 12, 14, 16/Any
• Non-randomized (NR): 0, 8, 10, 12, 16/Any
2a)
• R: Wk 8, 9, 10, 11, 12, 14, 16/Any, 17/Any
• NR: 8, 10, 12, 16/Any, 17/Any
2b)
• R: Wk -1 to -4, 0, 1, 2, 3, 4, 6, 8, 9, 10, 11, 12, 14, 16/Any, 17/Any
• NR: Wk -1 to -4, 0, 1, 2, 3, 4, 6, 8, 10, 12, 16/Any, 17/Any
2c)
• R & NR: Wk -4 to -1, 0, 8, 12, 16/Any
2d)
• R & NR: Wk -4 to -1, 0, 8, 16/Any
3-6)
• R: Wk -4 to -1, 0, 6, 8, 9, 10, 11, 12, 14, 16/Any
• NR: Wk -4 to -1, 0, 6, 8, 10, 12, 16/Any
7-10+13) R & NR: Wk 0, 8, 16/Any
11) R & NR: Wk 0 and 8
12)
• R: Wk 1, 2, 3, 4, 6, 8, 9, 10, 11, 12, 14, 16/Any
• NR: Wk 1, 2, 3, 4, 6, 8, 10, 12, and 16/Any
14) R & NR: Wk 17/Any

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

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Withdrawal symptoms

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Flexible Dose Titration

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

Czech Republic

Germany

Hungary

Poland

Romania

South Africa

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

Last Subject Last Visit

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

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:

1012

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

101

F.4.2

For a multinational trial

F.4.2.1

In the EEA

536

F.4.2.2

In the whole clinical trial

1034

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)

Eligible subjects will have the option to enter a 12-month extension safety and tolerability study.

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

2012-03-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-02-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-12-10

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Clinical trials