urasidone extension study for the treatment of schizophrenia in paediatric patients

• Conditions: Schizophrenia; MedDRA version: 16.1Level: LLTClassification code 10001064Term: Acute schizophreniaSystem Organ Class: 100000004873; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-001694-24-Outside-EU/EEA
• Lead Sponsor: Sunovion Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-14
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 295

Inclusion Criteria

1. Subjects must provide written informed assent and be willing to participate in the study.
Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects’ adherence to the study procedures.
2. Male or female subjects 13 to 17 years of age
3. Subject has completed Study D1050301 (Visit 9), inclusive and all required assessments.
4. Willing and able to adhere to protocol-specified meal requirements during dosing.
5. Willing and able to swallow the size and number of lurasidone tablets specified per protocol.

Are the trial subjects under 18? yes
Number of subjects for this age range: 295
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subject is considered by the investigator to be at imminent risk of suicide.
2. Subject has evidence of any chronic organic disease of the CNS.

Study & Design

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