Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
D1050234
Study information
Scientific title
Acronym
PEARL 3 Extension Study
Study hypothesis
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 long-term among schizophrenic outpatients with chronic schizophrenia.
Ethics approval
USA: Copernicus Group IRB, approved on 05/09/2008.
All other centres will seek ethics approval before recruitment of the first participant.
Study design
Randomised double-blind active comparator-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Schizophrenia
Intervention
Subjects who meet entry criteria will continue treatment with either flexibly dosed lurasidone or quetiapine XR based on their treatment assignment in Study D1050233 in a double-blinded fashion. Subjects treated with placebo in Study D1050233 will be treated with lurasidone.
Arm 1: Lurasidone HCI 40-160 mg/day orally for 12 months
Arm 2: Quetiapine XR 200-800 mg/day orally for 12 months
Intervention type
Drug
Phase
Phase III
Drug names
Lurasidone HCl, quetiapine XR
Primary outcome measure
1. Primary efficacy endpoint:
1.1. Time to relapse of psychotic symptoms in subjects to measure the long-term maintenance of antipsychotic efficacy of lurasidone compared with quetiapine XR.
2. Primary safety endpoints:
The proportion of subjects with:
2.1. Adverse Events (AEs)
2.2. Discontinuations due to AEs
2.3. Serious Adverse Events (SAEs)
AEs will be monitored throughout the study until Month 12.
Secondary outcome measures
Efficacy endpoints of interest:
Time to relapse of psychotic symptoms. Mean change from D1050233 baseline in the Positive and Negative Syndrome Scale (PANSS): positive score, negative score, and excitability score. PANSS will be carried out at Month 3, 6, 9, 12 in this extension study.
Overall trial start date
01/12/2008
Overall trial end date
01/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Screening for the present study will take place after subjects' participation in Study D1050233 has been completed, and after providing informed consent.
Principal inclusion criteria:
1. Males and females 18-75 years of age inclusive
2. Provide written informed consent
3. Completed all required assessments on the final study visit in Study D1050233
4. Suitable for treatment in an outpatient setting
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Approximately 240
Participant exclusion criteria
1. Any chronic organic disease of the central nervous system (CNS) (other than schizophrenia)
2. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property
Recruitment start date
01/12/2008
Recruitment end date
01/12/2010
Locations
Countries of recruitment
Colombia, Germany, India, Philippines, Romania, Russian Federation, Ukraine, United States of America
Trial participating centre
Dainippon Sumitomo Pharma America Inc.
New Jersey
07024
United States of America
Sponsor information
Organisation
Dainippon Sumitomo Pharma America Inc. (USA)
Sponsor details
One Bridge Plaza
Suite 510
Fort Lee
New Jersey
07024
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Dainippon Sumitomo Pharma Co. Ltd. (Japan)
Alternative name(s)
Dainippon Sumitomo Pharma Co., Ltd.
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
Japan
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list