Clinical Trials Register

Summary
EudraCT Number:	2007-000576-16
Sponsor's Protocol Code Number:	R076477PSZ3001
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2012-03-09
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
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

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A. Protocol Information

A.2

EudraCT number

2007-000576-16

A.3

Full title of the trial

A Randomized, Multicenter, Double-Blind, Weight-Based, Fixed-Dose,
Parallel-Group, Placebo-Controlled Study of the Efficacy and Safety of
Extended Release Paliperidone for the Treatment of Schizophrenia in
Adolescent Subjects, 12 to 17 Years of Age

A.3.1

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

A Double-blind, Placebo-controlled Study of the Safety and Efficacy of
Paliperidone Extended Release (ER) in the Treatment of Schizophrenia in
Adolescent Patients

A.4.1

Sponsor's protocol code number

R076477PSZ3001

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00518323

A.5.4

Other Identifiers

Name:

Original Study ID:

Number:

CR002368

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/154/2011

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Janssen-Cilag International NV
B.1.3.4	Country	Belgium
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	Janssen-Cilag International NV
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Janssen-Cilag International NV, Turnhoutseweg 30, Belgium
B.5.2	Functional name of contact point	Michael B Emanuel
B.5.3	Address:
B.5.3.1	Street Address	50-100 Holmers Farm Way
B.5.3.2	Town/ city	Buckinghamshire
B.5.3.3	Post code	HP12 4DP
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	441494658336
B.5.5	Fax number	441494658499
B.5.6	E-mail	memanuel@gcogb.jnj.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	INVEGA prolonged release tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag International, NV
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	paliperidone ER
D.3.2	Product code	F067
D.3.4	Pharmaceutical form	Prolonged-release 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	Paliperidone
D.3.9.1	CAS number	144598-75-4
D.3.9.2	Current sponsor code	R076477
D.3.9.3	Other descriptive name	PALIPERIDONE
D.3.9.4	EV Substance Code	SUB23268
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	1.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Paliperidone
D.3.9.1	CAS number	144598-75-4
D.3.9.2	Current sponsor code	R076477
D.3.9.3	Other descriptive name	PALIPERIDONE
D.3.9.4	EV Substance Code	SUB23268
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	3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Paliperidone
D.3.9.1	CAS number	144598-75-4
D.3.9.2	Current sponsor code	R076477
D.3.9.3	Other descriptive name	PALIPERIDONE
D.3.9.4	EV Substance Code	SUB23268
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	6
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Paliperidone
D.3.9.1	CAS number	144598-75-4
D.3.9.2	Current sponsor code	R076477
D.3.9.3	Other descriptive name	PALIPERIDONE
D.3.9.4	EV Substance Code	SUB23268
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	12
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
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

Adolescent Schizophrenia

E.1.1.1

Medical condition in easily understood language

Adolescent 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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10008525
E.1.2	Term	Childhood 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 of this study is to evaluate the efficacy, safety and tolerability of three weight-based, fixed-dose groups of paliperidone ER (to fully explore the tolerability range) as
compared with placebo in adolescent subjects 12 to 17 years of age, inclusive, with schizophrenia.

E.2.2

Secondary objectives of the trial

The secondary objectives are to:
• Assess the change in the global impression of severity of illness
associated with the use of paliperidone ER compared with placebo as measured by the Clinical Global Impression Severity (CGI-S) scale.
• Assess the benefits in psychological, social, and school functioning associated with treatment with paliperidone ER compared with placebo as measured by the Children's Global Assessment Scale (CGAS).
• Explore the pharmacokinetics of paliperidone ER and the relationship between its pharmacokinetics and the results of the efficacy parameters (e.g., Positive and Negative Syndrome Scale [PANSS]) and safety parameters (e.g., extrapyramidal symptoms
[EPS], adverse events) of interest.

An exploratory secondary objective is to assess the effect on sleep
associated with treatment with paliperidone ER as measured by the sleep Visual Analog Scale (VAS).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Males or females between 12 and 17 years of age, inclusive, with a
body weight of at least 29 kg, who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) criteria for schizophrenia at least 1 year before screening and who had a PANSS total score between 60 and 120, inclusive, at screening and baseline. Eligible subjects were otherwise physically healthy based on medical history, physical examination, electrocardiogram (ECG), and laboratory
test results.

E.4

Principal exclusion criteria

• Subjects who, at screening, met the DSM-IV criteria for dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance-induced psychotic disorder.
• Subjects with mild, moderate, or severe mental retardation (ie,
documented intelligence quotient [IQ] <70), established by previous IQ testing or history;
• History or presence of circumstances that could have increased the risk of the occurrence of torsade de pointes or sudden death in
association with the use of drugs that prolong the QT interval corrected for heart rate (QTc)

E.5 End points

E.5.1

Primary end point(s)

Primary Outcome Measures:
•Change in the PANSS Total Score From Baseline to the Last
Postrandomization Assessment in the Double-blind Period of the
Study. The Positive and Negative Syndrome Scale (PANSS) measures the severity of psychotic symptoms of schizophrenia. Scores range from 30 to 210, where 30=best and 210=worst. The change in PANSS total score for all eligible subjects was measured from the beginning of the study to the end.

E.5.1.1

Timepoint(s) of evaluation of this end point

According to time and events schedule over 6 week duration of study

E.5.2

Secondary end point(s)

Secondary Outcome Measures:
•Change From Baseline to End Point in Clinical Global Impression-
Severity (CGI-S) Scale
The CGI-S rating scale was used to assess the severity of a subject's overall clinical condition. Scores range from 1 to 7, where 1=best and 7=worst.
•Change From Baseline to End Point in Children's Global Assessment (CGAS) Score
The CGAS score assesses psychological, social, and school functioning for children 6 to 17 years of age. Scores range from 1 to 100, where 100=best and 1=worst.
•Change From Baseline to End Point in Sleep Visual Analog Scale (VAS) for Quality of Sleep.
The sleep VAS for sleep quality is a scale for measuring the quality of sleep experienced by a patient. Scores range from 0 to 100, where 100=best and 0=worst.
•Change From Baseline to End Point in Sleep VAS for Daytime
Drowsiness
The sleep VAS for daytime drowsiness is a scale for measuring the
drowsiness experienced by a patient. Scores range from 0 to 100,
where 100=best and 0=worst.

E.5.2.1

Timepoint(s) of evaluation of this end point

According to time and events schedule over 6 week duration of 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

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

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

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

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

Will this trial be conducted at a single site globally?

E.8.4

Will this trial be conducted at multiple sites globally?

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

India

Russian Federation

Ukraine

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 visit of last subject undergoing trial

E.8.9 Initial estimate of the duration of the trial

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:

201

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

201

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Subject must give an assent to participate before screening procedures began. Subjects who did not give assent to participate were not to be included in the study;

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

201

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)

For subjects not entering the open-label study, a follow-up visit will be scheduled 1 week after completion of the study or upon early discontinuation to monitor for adverse events.

G. Investigator Networks to be involved in the Trial

H.4 Third Country in which the Trial was first authorised
H.4.1	Third Country in which the trial was first authorised:	India

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