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Prevention of Relapse With Injectable Paliperidone Palmitate Versus Oral Antipsychotics (PROSIPAL)

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ClinicalTrials.gov Identifier: NCT01081769
Recruitment Status : Completed
First Posted : March 5, 2010
Results First Posted : February 18, 2015
Last Update Posted : February 18, 2015
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: paliperidone palmitate injection
Drug: oral antipsychotics

  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
After randomization patients enrolled in a 2-week oral treatment phase and were considered part of the whole Intent-to-Treat population (Whole ITT). Five patients did not receive study medication after randomization and were excluded from the whole ITT. Only responders were considered for continuation in the Core treatment phase (Core ITT).

Reporting Groups
  Description
Paliperidone Palmitate 2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter
Oral Antipsychotics Oral antipsychotics daily treatment according to local label for maximally 24 months

Participant Flow for 2 periods

Period 1:   Whole Intent-to-Treat
    Paliperidone Palmitate   Oral Antipsychotics
STARTED   376   388 
COMPLETED   352   363 
NOT COMPLETED   24   25 
Missing Responder Assessment                10                12 
Stopped; non-responder after 2 weeks                6                6 
Deviation; non-responder after 2 weeks                6                7 
Responder after 2 weeks, but stopped                2                0 

Period 2:   CORE Intent-To-Treat
    Paliperidone Palmitate   Oral Antipsychotics
STARTED   352   363 
COMPLETED   272   266 
NOT COMPLETED   80   97 
Adverse Event                14                11 
Death                1                1 
Lack of Efficacy                2                6 
Lost to Follow-up                4                5 
Pregnancy                1                0 
Withdrawal by Subject                52                60 
Noncompliance With Study Drug                0                5 
Other                0                1 
Ineligibility                3                4 
Visit Schedule Issues                1                2 
Patient Moved                2                2 



  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.
Whole Intent-to-Treat population: All randomized patients who received at least 1 dose of study medication during the screening or treatment phase

Reporting Groups
  Description
Paliperidone Palmitate 2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter
Oral Antipsychotics Oral antipsychotics daily treatment according to local label for maximally 24 months
Total Total of all reporting groups

Baseline Measures
   Paliperidone Palmitate   Oral Antipsychotics   Total 
Overall Participants Analyzed 
[Units: Participants]
 376   388   764 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.5  (10.73)   32.4  (10)   32.5  (10.36) 
Gender 
[Units: Participants]
     
Female   147   171   318 
Male   229   217   446 
Region of Enrollment 
[Units: Participants]
     
AUSTRIA   0   1   1 
BELGIUM   7   5   12 
BULGARIA   15   15   30 
CROATIA   12   12   24 
CZECH REPUBLIC   14   21   35 
EGYPT   16   14   30 
ESTONIA   2   3   5 
FRANCE   4   4   8 
GERMANY   3   2   5 
HUNGARY   15   16   31 
ISRAEL   6   5   11 
ITALY   10   11   21 
JORDAN   15   11   26 
KOREA, REPUBLIC OF KOREA   2   4   6 
LITHUANIA   13   14   27 
POLAND   11   11   22 
ROMANIA   13   14   27 
RUSSIAN FEDERATION   90   90   180 
SLOVAKIA   13   14   27 
SOUTH AFRICA   26   24   50 
SPAIN   3   4   7 
TAIWAN, PROVINCE OF CHINA   4   5   9 
TURKEY   11   9   20 
UKRAINE   71   79   150 


  Outcome Measures

1.  Primary:   Time to First Relapse Event   [ Time Frame: from baseline (Day 1 of core phase) up to maximally 24 months. ]

2.  Primary:   Number of Participants With a Relapse Event   [ Time Frame: from baseline (Day 1 of core phase) up to maximally 24 months ]

3.  Secondary:   Percentage of Treatment Responders   [ Time Frame: from baseline (day 1 of core phase) up to maximally 24 months ]

4.  Secondary:   Change From Baseline in PANSS Total Score   [ Time Frame: Baseline, day 8, month 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, 24 ]

5.  Secondary:   Change From Baseline in PANSS Subscale Score   [ Time Frame: Baseline (day 1 of core phase), day 8, month 12, 24 ]

6.  Secondary:   Change From Baseline in PANSS Marder Factor Scores   [ Time Frame: Baseline (day 1 of core phase), day 8, month 12 and 24 ]

7.  Secondary:   Change From Baseline in Clinical Global Impression Severity (CGI-S) Score   [ Time Frame: Baseline (day 1 of core phase), day 8, month 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, 24 ]

8.  Secondary:   Clinical Global Impression-Change (CGI-C)   [ Time Frame: Month 24 and endpoint ]

9.  Secondary:   Changes From Baseline in Personal and Social Performance (PSP) Total Score   [ Time Frame: baseline (day 1 of core phase), month 1, 3, 6, 9, 12, 15, 18, 21 and 24 ]

10.  Secondary:   Change From Baseline in Short Form-36 Health Survey (SF-36)   [ Time Frame: baseline (day 1 of core phase), month 6, 12 and 24 ]

11.  Secondary:   Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) VAS Score   [ Time Frame: baseline (day 1 of core phase), month 6, 12 and 24 ]

12.  Secondary:   Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score   [ Time Frame: baseline (day 1 of core phase), month 6, 12 and 24 ]

13.  Secondary:   Change From Baseline in Subjective Well-Being Under Neuroleptics-Short Form (SWN-S) Total Score   [ Time Frame: baseline (day 1 of core phase), month 6, 12 and 24 ]

14.  Secondary:   Change From Baseline in Patient’s Treatment Satisfaction   [ Time Frame: baseline (day 1 of core phase), month 12 and 24 ]

15.  Secondary:   Change From Baseline in Physician’s Treatment Satisfaction   [ Time Frame: baseline (day 1 of core phase), month 12 and 24 ]


  Serious Adverse Events


  Other Adverse Events


  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

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: EMEA Medical Affairs Director Psychiatry
Organization: Janssen-Cilag Germany
e-mail: ClinicalTrialDisclosure@its.jnj.com



Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT01081769     History of Changes
Obsolete Identifiers: NCT01359293
Other Study ID Numbers: CR015199
R092670SCH3005 ( Other Identifier: Janssen CTMS ID )
2008-002247-16 ( EudraCT Number )
First Submitted: March 4, 2010
First Posted: March 5, 2010
Results First Submitted: November 17, 2014
Results First Posted: February 18, 2015
Last Update Posted: February 18, 2015