A 12-WEEK, MULTICENTER, OPEN-LABEL EXTENSION STUDY IN SUBJECTS WITH SCHIZOPHRENIA

• Conditions: schizophrenia; MedDRA version: 14.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-004790-90-SK
• Lead Sponsor: Sunovion Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-30
• Last Update Posted: 18 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Subject provides written informed consent and is willing and able to comply with the protocol, in the opinion of the Investigator.

2. Subject has completed the 28 week Double-blind Phase of Study D1050238 and all required assessments on the final study visit (visit 42); OR
Subject has experienced a protocol-defined relapse during the Double-blind Phase of Study D1050238 and has completed all required assessments on the final study visit; OR
Subject had at least entered the Open-label Phase of Study D1050238 when the Sponsor stopped the study and has completed all required assessments on the final study visit.

3. Subject is judged by the Investigator to be suitable for participation in a 12-week clinical study involving open-label lurasidone treatment.

4. Subject is not pregnant at the extension baseline visit (must have a negative urine pregnancy test at the final study visit in Study D1050238) or nursing (must not be lactating) and is not planning pregnancy within the projected duration of the study.

5. Males and female subjects who are of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after the last dose of lurasidone has been taken. In the Investigator’s judgment, the subject will adhere to this requirement.
- Adequate contraception is defined as continuous use of either two barrier methods (eg, condom and spermicide or diaphragm with spermicide) or acceptable hormonal contraceptive. Acceptable hormonal contraceptives include the following: a) contraceptive implant (such as Norplant®); b) injectable contraception (such as medroxyprogesterone acetate injection); or c) oral contraception.
- Female subjects who are of non-reproductive potential, ie, a subject who is surgically sterile, has undergone tubal ligation, or is postmenopausal (defined as at least 12 months of spontaneous amenorrhea or between 6 and 12 months of spontaneous amenorrhea with follicle stimulating hormone concentrations within postmenopausal range as determined by laboratory analysis) are not required to remain abstinent or use adequate contraception.

6. Subject is in good physical health on the basis of physical examination at the extension baseline visit (performed at the final study visit in Study D1050238).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Subject is considered by the Investigator to be at imminent risk of suicide, injury to self or to others, or damage to property.

2. Subject answers yes to Suicidal Ideation item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the Columbia Suicide Severity Rating Scale (C-SSRS) at the extension baseline visit (final study visit in Study D1050238). Subjects who answer yes to this question must be referred to the Investigator for follow-up evaluation.

3. Subject requires treatment with any potent CYP3A4 inhibitors or inducers during the study. Subject requires treatment with a drug that consistently prolongs the QTc interval.

4. Subject currently has a clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder such as unstable angina, congestive heart failure (uncontrolled), or central nervous system (CNS) infection that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study. Subjects with human immunodeficiency virus (HIV) seropositivity (or history of seropositivity) will be excluded. Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if under control) must be discussed with the Medical Monitor before being enrolled in the study.

5. Subject exhibits evidence of severe tardive dyskinesia, severe dystonia, or any other severe movement disorder. Severity is to be determined by the Investigator.

6. Subject has presence of abnormal electrocardiogram (ECG) at the extension baseline visit (final study visit in Study D1050238), which in the Investigator’s opinion is clinically significant (Medical Monitor may be consulted to determine clinical significance).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified