Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00549718
First received: October 24, 2007
Last updated: June 5, 2014
Last verified: June 2014
Results First Received: November 8, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: Lurasidone HCl

  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
Lurasidone 40mg Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
Lurasidone 80mg lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
Lurasidone 120mg Lurasidone 40 mg tablets taken once/day
Placebo Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.

Participant Flow:   Overall Study
    Lurasidone 40mg     Lurasidone 80mg     Lurasidone 120mg     Placebo  
STARTED     125     123     124     128  
COMPLETED     84     86     85     73  
NOT COMPLETED     41     37     39     55  
Insufficient clinical response                 20                 7                 18                 32  
Adverse Event                 6                 8                 7                 3  
Lost to Follow-up                 4                 2                 0                 6  
Withdrawal by Subject                 9                 18                 12                 13  
Administrative                 2                 2                 2                 1  



  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.
No text entered.

Reporting Groups
  Description
Lurasidone 40mg Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
Lurasidone 80mg lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
Lurasidone 120mg Lurasidone 40 mg tablets taken once/day
Placebo Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
Total Total of all reporting groups

Baseline Measures
    Lurasidone 40mg     Lurasidone 80mg     Lurasidone 120mg     Placebo     Total  
Number of Participants  
[units: participants]
  122     119     124     124     489  
Age  
[units: years]
Mean ± Standard Deviation
  40.7  ± 11.1     38.6  ± 9.5     37.7  ± 11.2     38.2  ± 9.9     38.8  ± 10.5  
Gender  
[units: participants]
         
Female     40     43     32     34     149  
Male     82     76     92     90     340  
Region of Enrollment  
[units: participants]
         
France     0     1     1     1     3  
United States     70     64     70     67     271  
Malaysia     2     2     2     2     8  
Ukraine     13     12     12     14     51  
Romania     9     9     9     9     36  
Russian Federation     14     15     13     15     57  
India     14     16     17     16     63  



  Outcome Measures
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1.  Primary:   Change in Total PANSS Score From Baseline to the End of the Double Blind Phase   [ Time Frame: 6 weeks ]

2.  Secondary:   CGI-S From Baseline to the End of the Double-blind Treatment   [ Time Frame: 6 weeks ]


  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: Josephine Cucchiaro
Organization: Sunovion Pharmaceuticals Inc.
phone: 201-592-2050
e-mail: josephine.cucchiaro@sunovion.com


Publications of Results:

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00549718     History of Changes
Other Study ID Numbers: D1050229, 2007-003819-31
Study First Received: October 24, 2007
Results First Received: November 8, 2010
Last Updated: June 5, 2014
Health Authority: United States: Food and Drug Administration