A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01529515
First received: February 6, 2012
Last updated: May 18, 2015
Last verified: May 2015
Results First Received: April 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: PP3M 175 mg eq.
Drug: PP3M 263 mg eq.
Drug: PP3M 350 mg eq.
Drug: PP3M 525 mg eq.
Drug: Placebo (20% Intralipid emulsion)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 509 participants were enrolled in to the study and 506 participants were entered the Open-label Transition and received at least one dose of study drug (PP1M). 2 participants were enrolled but not received study drug and 1 participant was screen failure.

Reporting Groups
  Description
Open-Label Transition Phase: Paliperidone Palmitate 1-Month Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64.
Open-Label Maintenance Phase: Paliperidone Palmitate 3-Month Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 3.5-fold multiple of the PP1M dose received on Day 92 during the Transition Phase.
Double-Blind Phase: Placebo Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M) Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.

Participant Flow for 3 periods

Period 1:   TRANSITION PHASE
    Open-Label Transition Phase: Paliperidone Palmitate 1-Month     Open-Label Maintenance Phase: Paliperidone Palmitate 3-Month     Double-Blind Phase: Placebo     Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)  
STARTED     506     0     0     0  
COMPLETED     379     0     0     0  
NOT COMPLETED     127     0     0     0  
Adverse Event                 16                 0                 0                 0  
Death                 1                 0                 0                 0  
Lack of Efficacy                 19                 0                 0                 0  
Lost to Follow-up                 19                 0                 0                 0  
Protocol Violation                 4                 0                 0                 0  
Withdrawal by Subject                 51                 0                 0                 0  
Failed Maintenance Phase Criteria                 8                 0                 0                 0  
Unspecified                 9                 0                 0                 0  

Period 2:   MAINTENANCE PHASE
    Open-Label Transition Phase: Paliperidone Palmitate 1-Month     Open-Label Maintenance Phase: Paliperidone Palmitate 3-Month     Double-Blind Phase: Placebo     Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)  
STARTED     0     379     0     0  
COMPLETED     0     305     0     0  
NOT COMPLETED     0     74     0     0  
Adverse Event                 0                 10                 0                 0  
Lack of Efficacy                 0                 9                 0                 0  
Lost to Follow-up                 0                 5                 0                 0  
Protocol Violation                 0                 12                 0                 0  
Withdrawal by Subject                 0                 15                 0                 0  
Failed Randomization Criteria                 0                 13                 0                 0  
Unspecified                 0                 10                 0                 0  

Period 3:   DOUBLE BLIND PHASE
    Open-Label Transition Phase: Paliperidone Palmitate 1-Month     Open-Label Maintenance Phase: Paliperidone Palmitate 3-Month     Double-Blind Phase: Placebo     Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)  
STARTED     0     0     145     160  
COMPLETED     0     0     122     148  
NOT COMPLETED     0     0     23     12  
Adverse Event                 0                 0                 1                 0  
Lost to Follow-up                 0                 0                 1                 3  
Pregnancy                 0                 0                 1                 0  
Withdrawal by Subject                 0                 0                 10                 7  
Protocol Violation                 0                 0                 1                 0  
Unspecified                 0                 0                 9                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Double-Blind Phase: Placebo Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M) Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
Total Total of all reporting groups

Baseline Measures
    Double-Blind Phase: Placebo     Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)     Total  
Number of Participants  
[units: participants]
  145     160     305  
Age  
[units: years]
Mean (Standard Deviation)
  38.5  (11.16)     37.1  (10.87)     37.8  (11.01)  
Gender  
[units: participants]
     
Female     35     42     77  
Male     110     118     228  
Region of Enrollment  
[units: participants]
     
Colombia     12     13     25  
Malaysia     11     12     23  
Mexico     10     8     18  
Romania     14     13     27  
South Korea     4     2     6  
Turkey     5     6     11  
Ukraine     63     74     137  
United States     26     32     58  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Relapse During the Double-Blind Phase   [ Time Frame: Approximately Week 60 ]

2.  Secondary:   Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase   [ Time Frame: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60) ]

3.  Secondary:   Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase   [ Time Frame: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60) ]

4.  Secondary:   Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase   [ Time Frame: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director Clinical Research
Organization: Janssen Research & Development, LLC
e-mail: ClinicalTrialDisclosure@its.jnj.com


No publications provided


Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01529515     History of Changes
Other Study ID Numbers: CR100717, R092670PSY3012, 2011-004676-11, U1111-1135-1969
Study First Received: February 6, 2012
Results First Received: April 7, 2015
Last Updated: May 18, 2015
Health Authority: United States: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health
Turkey: Ministry of Health