Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia. (PEARL 3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00790192
First received: November 10, 2008
Last updated: April 9, 2013
Last verified: April 2013

November 10, 2008
April 9, 2013
October 2008
July 2010   (final data collection date for primary outcome measure)
Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
  • Primary Efficacy Endpoint: Mean change from baseline in total PANSS score at endpoint (Week 6). [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Primary Safety Endpoints: The proportion of subjects with: • Adverse Events (AEs) • Discontinuations due to AEs • Serious Adverse Events (SAEs) [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00790192 on ClinicalTrials.gov Archive Site
Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment [ Time Frame: 6-Weeks ] [ Designated as safety issue: No ]
Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).
  • Key Secondary Efficacy Endpoint: • Mean change from baseline in CGI-S score [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Key Secondary Efficacy Endpoint: • Mean change from baseline in PANSS total score on Day 4 [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.
A Phase 3 Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Two Doses of Lurasidone in Acutely Psychotic Subjects With Schizophrenia (PEARL 3)

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR short term among acutely psychotic patients with chronic schizophrenia.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Lurasidone
    Lurasidone 80 mg tablets
  • Drug: Lurasidone
    Lurasidone 4 40 mg tablets
  • Drug: Quetiapine XR
    Quetiapine XR 600mg
  • Drug: Placebo
    Matching Placebo to Lurasidone or Quetiapine
  • Experimental: Lurasidone 80mg
    Intervention: Drug: Lurasidone
  • Experimental: Lurasidone 160mg
    Intervention: Drug: Lurasidone
  • Active Comparator: Quetiapine XR
    Intervention: Drug: Quetiapine XR
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
488
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provide written informed consent and aged between 18 and 75 years of age.
  • Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.
  • Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
  • Able and agrees to remain off prior antipsychotic medication for the duration of study.
  • Good physical health on the basis of medical history, physical examination, and laboratory screening.
  • Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion Criteria:

  • Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
  • Any chronic organic disease of the CNS (other than schizophrenia).
  • Used investigational compound within 30 days.
  • Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   India,   Romania,   Russian Federation,   Ukraine
 
NCT00790192
D1050233
Yes
Sunovion
Sunovion
Not Provided
Study Director: Medical Director, MD Sunovion
Sunovion
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP