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Pharmacokinetics and Tolerability Study of Risperidone ISM® in Schizophrenia (PRISMA-2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02086786
First Posted: March 13, 2014
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rovi Pharmaceuticals Laboratories
Results First Submitted: October 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: Risperidone ISM

  Participant Flow
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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
No text entered.

Reporting Groups
  Description
Gluteus (Risperidone ISM)

Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals

Risperidone ISM

Deltoid (Risperdione ISM)

Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals

Risperidone ISM


Participant Flow:   Overall Study
    Gluteus (Risperidone ISM)   Deltoid (Risperdione ISM)
STARTED   35   35 
COMPLETED   17   19 
NOT COMPLETED   18   16 



  Baseline Characteristics
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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.
Three of the randomized patients (70) were not dosed. Two of them due to withdrawal of consent and the third due to fulfilment of one of the study exclusion criteria (take prohibited medication). Thus, the number of patients receiving the study medication were 67; 34 in the gluteal injection group and 33 in the deltoid injection group.

Reporting Groups
  Description
Gluteus (Risperidone ISM)

Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals

Risperidone ISM

Deltoid (Risperdione ISM)

Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals

Risperidone ISM

Total Total of all reporting groups

Baseline Measures
   Gluteus (Risperidone ISM)   Deltoid (Risperdione ISM)   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   33   67 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      34 100.0%      33 100.0%      67 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 41  (11.1)   44  (9.8)   43  (10.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7  20.6%      5  15.2%      12  17.9% 
Male      27  79.4%      28  84.8%      55  82.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   2.9%      0   0.0%      1   1.5% 
Asian      1   2.9%      1   3.0%      2   3.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      25  73.5%      28  84.8%      53  79.1% 
White      7  20.6%      4  12.1%      11  16.4% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   34   33   67 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Peak Plasma Concentration (Cmax) for Active Moiety   [ Time Frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose. ]

2.  Primary:   Trough Plasma Concentration (Cmin) for Active Moiety   [ Time Frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose. ]

3.  Primary:   Area Under the Curve to the Last Quantified Concentration (AUClast) for Active Moiety   [ Time Frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose. ]

4.  Primary:   Area Under the Curve Extrapolated to Infinity (AUC∞) for Active Moiety   [ Time Frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose. ]

5.  Primary:   AUCτ for Active Moiety   [ Time Frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose. ]

6.  Primary:   Time to Peak Concentration (Tmax) for Active Moiety   [ Time Frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose. ]

7.  Primary:   Terminal Half-life (t1/2) for Active Moiety   [ Time Frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose. ]

8.  Primary:   PTF for Active Moiety   [ Time Frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose. ]

9.  Secondary:   Accumulation Ratio (RA) for Active Moiety   [ Time Frame: Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose. ]

10.  Other Pre-specified:   Positive and Negative Syndrome Scale (PANSS) Total Score   [ Time Frame: Baseline, Days 5, 7, 10, 14, 18, and 21 post Dose 1; Dose 2, 3 and 4 post dose; Days 5, 7, 10, 14, 18, and 21 post Dose 2, 3, and 4; Days 25, 28, 32, 37, 42, 60, 75, 90, and 105 post Dose 4; Day 120 post Dose 4 or early termination. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Jordi Llaudó Garín ( Clinical Development Manager)
Organization: Rovi S.A. Laboratorios Farmacéuticos
phone: +34913756230
e-mail: jllaudo@rovi.es



Responsible Party: Rovi Pharmaceuticals Laboratories
ClinicalTrials.gov Identifier: NCT02086786     History of Changes
Other Study ID Numbers: ROV-RISP-2011-02
First Submitted: February 10, 2014
First Posted: March 13, 2014
Results First Submitted: October 13, 2016
Results First Posted: July 13, 2017
Last Update Posted: July 13, 2017