A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia

• Register: EUCTR
• Last refreshed on: 5 June 2017
• Main ID: EUCTR2006-006434-17-RO
• Date of registration: 15/11/2016
• Prospective Registration: No
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia
• Date of first enrolment: 03/05/2007
• Target sample size: 644
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006434-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Romania

Key inclusion & exclusion criteria

Inclusion criteria:
Subject must have the capacity to consent and must have signed the study informed consent document indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study

Man or woman 18 years of age (or the minimum age to provide informed consent in the jurisdiction in which the study is taking place, whichever is older).

Met diagnostic criteria for schizophrenia according to DSM IV (disorganized type [295.10], catatonic type [295.20], paranoid type [295.30], residual type [295.60] or undifferentiated type [295.90]) for at least 1 year before screening

A total PANSS score at screening of between 70 and 120, inclusive and at baseline of between 60 and 120, inclusive
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Primary active DSM-IV Axis I diagnosis other than schizophrenia

Subjects who are unable to provide their own consent or who have been involuntarily committed to psychiatric hospitalization

DSM-IV diagnosis of active substance dependence within 3 months before the screening evaluation (nicotine and caffeine dependence are not exclusionary)

History of treatment resistance as defined by failure to respond to 2 adequate studies of different antipsychotic medications; an adequate study is defined as a minimum of 4 weeks at the subject’s maximum tolerated dose·

Treatment with any of the following disallowed therapies:
- LAI antipsychotic (including RISPERDAL CONSTA) within 2 injection cycles before screening
- ECT within 60 days before screening
- Currently taking 3 or more antipsychotic medications
- Use of clozapine within 60 days before screening
- Use of aripiprazole within 2 weeks before baseline
- Nonselective or irreversible MAOI antidepressants within 4 weeks before screening
- Other antidepressants unless subject has been on a stable dose for at least 30 days before screening (if less than 30 days and subject does not require the antidepressant it may be washed out before the baseline visit; if less than 30 days and subject requires antidepressant treatment, the subject should not be included in the study)
- Mood stabilizers including lithium and all anticonvulsants within 4 weeks of screening
- Beta-blockers, within 4 weeks of screening, unless used for control of hypertension and subject's blood pressure has been stabilized (see Section 8.1, Allowed Concomitant Medications)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Schizophrenia
MedDRA version: 19.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders

Intervention(s)

Product Name: Paliperidone Palmitate 25 mg eq.
Product Code: R092670
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Paliperidone Palmitate
CAS Number: 199739-10-1
Current Sponsor code: R092670
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use

Product Name: Paliperidone Palmitate 100 mg eq.
Product Code: R092670
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Paliperidone Palmitate
CAS Number: 199739-10-1
Current Sponsor code: R092670
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use

Product Name: Paliperidone Palmitate 150 mg eq.
Product Code: R092670
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Paliperidone Palmitate
CAS Number: 199739-10-1
Current Sponsor code: R092670
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use

Product Name: Paliperidone 6mg ER
Product Code: R076477
Pharmaceutical Form: Tablet
CAS Number: 144598-75-4
Current Sponsor code: R076477
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6-

Primary Outcome(s)

Main Objective: The primary objectives of this study are to evaluate the efficacy and safety of 3 fixed doses of paliperidone palmitate administered i.m. after an initial loading dose of 150 mg eq. for a total of 13 weeks of treatment as compared with placebo in subjects with schizophrenia.

Secondary Objective: Assess the benefits in personal and social functioning (key secondary endpoint) associated with the use of paliperidone palmitate compared with placebo

Assess the global improvement in severity of illness associated with the use of paliperidone palmitate compared with placebo

Assess the dose-response and exposure-response relationship of paliperidone palmitate

Primary end point(s): The primary endpoint will be the change in the total score of the PANSS from baseline to the end of the double-blind treatment period (i.e., on Day 92 or the last post-randomization assessment).(as defined on page 50 of the protocol )

Secondary ID(s)

R092670PSY3007