Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients with Schizophrenia

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2011-004889-15-BG
• Date of registration: 30/11/2012
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients with Schizophrenia
• Scientific title: A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects with Schizophrenia
• Date of first enrolment: 21/01/2013
• Target sample size: 1388
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004889-15
• 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: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Japan, Korea, Republic of, Luxembourg, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Sweden, Taiwan, Ukraine, United States

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

Key inclusion & exclusion criteria

Inclusion criteria:
- Patients with schizophrenia for more than 1 year and whose symptoms are worsening in the opinion of the investigator - A total score in the Positive and Negative Syndrome Scale (PANSS) between 70 and 120 - Signed informed consent - Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control - Men must agree to use a double-barrier method of birth control - Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG)
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 1375
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion criteria:
- A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis -Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc) - A diagnosis of substance dependence within 6 months before screening - History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia - Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness – Clinically significant findings in biochemistry, hematology, ECG or urinalysis results - Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments


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

Health Condition(s) or Problem(s) studied

Schizophrenia
MedDRA version: 14.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders

Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Intervention(s)

Trade Name: Xeplion
Product Name: paliperidone palmitate - extended release suspension for injection - 50 mg
Product Code: R092670
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: paliperidone palmitate
CAS Number: 199739101
Current Sponsor code: R092670
Other descriptive name: PALIPERIDONE PALMITATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: Xeplion
Product Name: paliperidone palmitate - extended release suspension for injection - 75 mg
Product Code: R092670
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: paliperidone palmitate
CAS Number: 199739101
Current Sponsor code: R092670
Other descriptive name: PALIPERIDONE PALMITATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: Xeplion
Product Name: paliperidone palmitate - extended release suspension for injection - 100 mg
Product Code: R092670
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: paliperidone palmitate
CAS Number: 199739101
Current Sponsor code: R092670
Other descriptive name: PALIPERIDONE PALMITATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: Xeplion
Product Name: paliperidone palmitate - extended release suspension for injection - 150 mg
Product Code: R092670
Ph

Primary Outcome(s)

Main Objective: To demonstrate, in patients stabilized on the paliperidone palmitate 1 month formulation (PP1M), that paliperidone palmitate 3 month formulation (PP3M) is not less effective than PP1M in the treatment of symptoms of schizophrenia, based on the Kaplan-Meier 48-week cumulative estimate of survival (ie, percentage of subjects remaining relapse free).

Primary end point(s): The primary efficacy endpoint of the study is the percentage of subjects who have not relapsed at the end of the 48-week Double-blind Phase based on the Kaplan-Meier 48-week cumulative estimate of survival (ie, percentage of subjects remaining relapse free).

Secondary Objective: • Evaluate the change from baseline in the positive and negative symptoms of schizophrenia associated with the use of PP3M compared with PP1M.
• Assess the change in the severity of illness associated with the use of PP3M compared with PP1M.
• Assess the change in functional status with the use of PP3M compared to PP1M.
• Assess symptomatic remission achieved during treatment with PP3M compared to PP1M.
• Assess the safety and tolerability of PP3M and PP1M.
• Assess the pharmacokinetics of PP3M, including its relationship with demographic and dose-related variables.

Timepoint(s) of evaluation of this end point: 48 weeks of the Double-blind Phase

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Baseline and 48 weeks of the Double-blind Phase

For the proportion of patients who meet criteria for symptomatic remission - Week 24 to 48 of the Double-blind Phase

Secondary end point(s): -The changes from baseline in the neuropsychiatric symptoms of schizophrenia using the Positive and Negative Syndrome Scale (PANSS) during the Double-blind Phase.
-The changes from baseline in the patient’s overall clinical condition measured by the change in Clinical Global Impression Severity (CGI-S) scale during the Double-blind Phase.
-The changes from baseline in the patient’s functional status, measured by the Personal and Social Performance (PSP) scale during the Double-blind Phase.
-The proportion of patients who meet criteria for symptomatic remission.

Secondary ID(s)

2011-004889-15-CZ

R092670PSY3011

Source(s) of Monetary Support

Janssen Research & Development

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 04/06/2016
• Date Completed: 02/03/2015
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-004889-15/results