Clinical Trials Register

Summary
EudraCT Number:	2013-001694-24
Sponsor's Protocol Code Number:	D1050302
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-09-10
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

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2013-001694-24

A.3

Full title of the trial

A 104-WEEK, FLEXIBLE-DOSE, OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF LURASIDONE IN PEDIATRIC SUBJECTS

A.3.1

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

A 104-WEEK, FLEXIBLE-DOSE, OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF LURASIDONE IN PEDIATRIC SUBJECTS

A.4.1

Sponsor's protocol code number

D1050302

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/145/2012

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	SUNOVION PHARMACEUTICALS 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	Sunovion Pharmaceuticals 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	Sunovion Pharmaceuticals Inc.
B.5.2	Functional name of contact point	Robert Goldman
B.5.3	Address:
B.5.3.1	Street Address	One Bridge Plaza Suite 510
B.5.3.2	Town/ city	Fort Lee,
B.5.3.3	Post code	NJ 07024
B.5.3.4	Country	United States
B.5.4	Telephone number	1201-592-2050
B.5.6	E-mail	Robert.Goldman@sunovion.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	LATUDA
D.2.1.1.2	Name of the Marketing Authorisation holder	Sunovion Pharmaceuticals 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	LURASIDONE
D.3.2	Product code	SM-13496
D.3.4	Pharmaceutical form	Film-coated tablet
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	Lurasidone Hydrochloride
D.3.9.1	CAS number	367514-88-3
D.3.9.3	Other descriptive name	SM-13496
D.3.9.4	EV Substance Code	SUB34204
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	LATUDA
D.2.1.1.2	Name of the Marketing Authorisation holder	Sunovion Pharmaceuticals 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	LURASIDONE
D.3.2	Product code	SM-13496
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Yes
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	Lurasidone Hydrochloride
D.3.9.1	CAS number	367514-87-2
D.3.9.3	Other descriptive name	LURASIDONE
D.3.9.4	EV Substance Code	SUB32185
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	40
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

Extension study for the D1050301 Adolescent Schizophrenia study, the D1050325 Children and Adolescent autistic disorder and the D1050326 Children and Adolescent Bioplar I Depression

E.1.1.1

Medical condition in easily understood language

Subjects who completed participation in preceding studies with lurasidone will be eligible in this study.

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10004936
E.1.2	Term	Bipolar depression
E.1.2	System Organ Class	10037175 - Psychiatric disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	HLGT
E.1.2	Classification code	10039628
E.1.2	Term	Schizophrenia and other psychotic disorders
E.1.2	System Organ Class	10037175 - Psychiatric disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10003808
E.1.2	Term	Autistic disorder
E.1.2	System Organ Class	100000004852

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, tolerability, and effectiveness of lurasidone (20, 40, 60 or 80 mg/day, flexibly dosed) in pediatric subjects who have completed a prior lurasidone study.

E.2.2

Secondary objectives of the trial

• Proportions of subjects with adverse events (AEs), discontinuations due to AEs, and serious AEs (SAEs). Subjects from D1050301: • Change in Positive and Negative Syndrome, general psychopathology, and excitability; in the Clinical Global Impression; in the Clinician-rated Children’s Global Assessment Scale; in the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire. Subjects from D1050325: • Change in Aberrant Behavior;in the Clinical Global Impression – Severity; in Children's Yale-Brown Obsessive Compulsive Scales modified for pervasive developmental disorders; in the Caregiver Strain Questionnaire. Subjects from D1050326: • Change in the Children's Depression Rating Scale, the Clinical Global Impression Bipolar Version ; in the Clinician-rated Children’s Global Assessment Scale; in the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire; in anxiety symptoms as measured by the Pediatric Anxiety Rating Scale; in attention-deficit/hyperactivity

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects’ participation in the study procedures must be obtained for subjects who are not emancipated. In accordance with Institutional Review Board (IRB) or Independent Ethics Committee (IEC) requirements, the subject will complete an informed assent when developmentally appropriate, to participate in the study before conduct of any study-specific procedures. 2. Subject has completed Study D1050301 or 325 (Visit 9); OR Subject has completed Study D1050326 (Visit 8). 3. Subject is judged by the investigator to be appropriate for participation in a 104-week clinical trial in an outpatient setting involving open-label lurasidone treatment, and is able to comply with the protocol. 4. A reliable informant (eg, parent, legal guardian, or caregiver) must be available to accompany the subject at each visit. For subjects entering from Study D1050325, the reliable caregiver must also oversee the administration of the study drug throughout the study. 5. Females who participate in this study: • are unable to become pregnant (eg, premenarchal, surgically sterile, etc.) -OR- • practices true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent to at least 7 days after the last dose of study drug has been taken; -OR- • are sexually active and willing to use a medically effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken. 6. Males must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken

E.4

Principal exclusion criteria

1. Subject is considered by the investigator to be at imminent risk of suicide.
2. Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardive dyskinesia, or any other moderate or severe movement disorder. Severity to be determined by the investigator

E.5 End points

E.5.1

Primary end point(s)

6.1. Safety Assessments All Subjects: • Treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation and serious AEs (SAEs); • Laboratory tests, vital signs, body weight and body mass index (BMI), waist circumference, physical examination, height (as measured by stadiometer), electrocardiogram (ECG), hormonal parameters; • Movement disorders as assessed by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and the Simpson-Angus Scale (SAS); • Tanner staging, and menstrual cyclicity (female subjects). For subjects continued from Study D1050301 and D1050326: • Columbia Suicide Severity Rating Scale (C-SSRS); • Composite Score of the CogState Computerized Cognitive Test Battery; • Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU). For subjects continued from Study D1050326: • Young Mania Rating Scale (YMRS) score. 6.2. Effectiveness Assessments For subjects continued from Study D1050301: • Positive and Negative Syndrome Scale (PANSS); • Clinical Global Impression-Severity (CGI-S) scale; • Clinician-rated Children’s Global Assessment Scale (CGAS); • Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q). For subjects continued from Study D1050325: • Aberrant Behavior Checklist (ABC); • Clinical Global Impression-Severity (CGI-S) scale; • Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for pervasive developmental disorders (PDDs); • Caregiver Strain Questionnaire (CGSQ). For subjects continued from Study D1050326: • Children's Depression Rating Scale, Revised (CDRS-R); • Clinical Global Impression Bipolar Version -Severity (CGI-BP-S) scale; Clinician-rated Children’s Global Assessment Scale (CGAS); • Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q); • Pediatric Anxiety Rating Scale (PARS); • Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS

E.5.1.1

Timepoint(s) of evaluation of this end point

throughout the study

E.5.2

Secondary end point(s)

see all listed under E.5.1 above

E.5.2.1

Timepoint(s) of evaluation of this end point

throughout the study

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

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

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

Belgium

Bulgaria

China

Colombia

Finland

France

Germany

Hungary

Italy

Korea, Republic of

Malaysia

Mexico

Philippines

Poland

Puerto Rico

Romania

Serbia

Spain

Ukraine

United Kingdom

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

Visit 29E EOS/ET (Week 104)

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

Yes

F.1.1

Number of subjects for this age range:

574

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

114

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

460

F.1.2

Adults (18-64 years)

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

121

F.4.2.2

In the whole clinical trial

574

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)

Please ref to:
Section 11.4.30 of the protocol: 'Follow-Up: Visit 30 Week 105' (pages 60-61)
2nd paragraph of the section 12.2 (of the protocol): 'Follow-up Procedures Upon Discontinuation or Withdrawal' (page 62)

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

2014-11-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-11-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-10-17

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