Clinical Trials Register

Summary
EudraCT Number:	2016-000061-23
Sponsor's Protocol Code Number:	D1001067
National Competent Authority:	Slovakia - SIDC (Slovak)
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-06-01
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

Slovakia - SIDC (Slovak)

A.2

EudraCT number

2016-000061-23

A.3

Full title of the trial

A 12-Week, Open-Label Extension Study of Lurasidone (SM-13496) in Subjects with Schizophrenia

A.3.1

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

A 12-Week Extension Study looking at the effects of Lurasidone (SM-13496) in Subjects with Schizophrenia

A.4.1

Sponsor's protocol code number

D1001067

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	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 S Goldman
B.5.3	Address:
B.5.3.1	Street Address	84 Waterford Drive
B.5.3.2	Town/ city	Marlborough
B.5.3.3	Post code	MA 01752
B.5.3.4	Country	United States
B.5.4	Telephone number	+1201592 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
D.3.9.1	CAS number	367514-88-3
D.3.9.2	Current sponsor code	SM-13496
D.3.9.3	Other descriptive name	LURASIDONE HYDROCHLORIDE
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	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.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	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
D.3.9.1	CAS number	367514-88-3
D.3.9.2	Current sponsor code	SM-13496
D.3.9.3	Other descriptive name	LURASIDONE HYDROCHLORIDE
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	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

Schizophrenia

E.1.1.1

Medical condition in easily understood language

Schizophrenia

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10039626
E.1.2	Term	Schizophrenia
E.1.2	System Organ Class	10037175 - Psychiatric disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to evaluate the long-term safety of lurasidone (40 and 80 mg/day) in subjects with schizophrenia who have completed participation in Study D1001066.

E.2.2

Secondary objectives of the trial

The secondary objective is to evaluate the long-term effectiveness of lurasidone (40 and 80 mg/day) in subjects with schizophrenia who have completed participation in Study D1001066.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subject must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study-related activities. If the subject is considered a minor per local regulations at the time of collection of the informed consent, written consent will be obtained from a legally acceptable representative (guardian) in addition to that obtained from the subject.
2. Subject has completed the 6-week double-blind phase of study D1001066 and has completed all required assessments on the final study visit.
3. Subject is judged to be suitable for participation in a 12-week clinical study involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.
4. Female subjects must not be pregnant (must have a negative urine pregnancy test at Visit 1E [Study Visit Number 9 in Study D1001066]) nor nursing (must not be lactating) and not planning to become pregnant within the projected duration of the study.
5. Female subjects who are of childbearing potential and male subjects whose partners are of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for 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 or injury to self or others, or subject answers “yes” to “Suicidal Ideation” item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at Visit 1E (Study Visit Number 9 in Study D1001066). Subjects who answer “yes” to this question must be referred by the Investigator for appropriate follow-up evaluation and treatment.
2. Subject exhibits evidence of severe tardive dyskinesia, severe dystonia, or any other severe movement disorder. Severity is to be determined by the Investigator.
3. Subject requires treatment with any potent CYP3A4 inhibitors or inducers during the study.
4. Subject is otherwise considered ineligible for the study by the Investigator.

E.5 End points

E.5.1

Primary end point(s)

Safety Endpoint
• Frequency of adverse events (AEs) or treatment-related AEs, extrapyramidal AEs, SAEs, and AEs leading to study discontinuation;
• Absolute values and changes from Open-label and Double-blind Baseline in:
− Laboratory test values including: measures of glycemic control and lipids;
− Vital signs;
− Body weight, waist circumference, and body mass index (BMI);
− Electrocardiogram (ECG) parameters including corrected QT (QTc) interval.
• Proportions of subjects using concomitant antiparkinsonian drugs;
• Change from Open-label and Double-blind Baseline in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) total score (excluding the overall severity) at each post-baseline visit;
• Frequency of subjects with suicidal behaviour and suicidal ideation measured by Columbia-Suicide Severity Rating Scale (C-SSRS).

E.5.1.1

Timepoint(s) of evaluation of this end point

Various time points throughout the study

E.5.2

Secondary end point(s)

Efficacy Endpoint
• Change from Open-label and Double-blind Baseline in Positive and Negative Syndrome Scale (PANSS) total score at each post-baseline visit;
• Change from Open-label and Double-blind Baseline in Clinical Global Impression-Severity Scale (CGI-S) score at each post-baseline visit;
• Change from Open-label and Double-blind Baseline in PANSS subscale scores at each post-baseline visit;
• Change from Open-label and Double-blind Baseline in PANSS five-factor model scores at each post-baseline visit. The PANSS five-factor model is defined as follows:
− Negative symptoms: Blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of spontaneity and flow of conversation, and active social avoidance;
− Excitement: Excitement, hostility, tension, and poor impulse control;
− Cognitive disorders: Conceptual disorganization, difficulty in abstract thinking, mannerisms and posturing, disorientation, and poor attention;
− Positive symptoms: Delusions, grandiosity, suspiciousness/persecution, and unusual thought content;
− Anxiety/depression: Somatic concern, anxiety, guilt feelings, depression, and preoccupation.
• Change from Open-label and Double-blind Baseline in Calgary Depression Scale for Schizophrenia (CDSS) total scores at each post-baseline visit.
• Time to all-cause discontinuation from Open-label Baseline.

Other Endpoint
• Change from Open-label and Double-blind Baseline in Euroqol-5 Dimensions-3 Levels (EQ-5D-3L) index score at Week 12.

E.5.2.1

Timepoint(s) of evaluation of this end point

Various time points 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.8.3

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

India

Japan

Romania

Russian Federation

Slovakia

Ukraine

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

LVLS

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:

273

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

283

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)

Normal treatment

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

2016-07-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-03-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-01-31

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