Long-Term Study of MP-214 in Patients With Schizophrenia

This study is currently recruiting participants.
Verified January 2014 by Mitsubishi Tanabe Pharma Corporation
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01626872
First received: June 19, 2012
Last updated: January 6, 2014
Last verified: January 2014

June 19, 2012
January 6, 2014
June 2012
Not Provided
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 60 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01626872 on ClinicalTrials.gov Archive Site
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Long-Term Study of MP-214 in Patients With Schizophrenia
Long-Term Extension Study of MP-214 in Patients With Schizophrenia

The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with schizophrenia.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: MP-214 low dose
    Participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts low or middle dose of MP-214) and will be re-randomized after Week 6 to low dose or middle dose of MP-214
  • Drug: MP-214 middle dose
    Participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts low or middle dose of MP-214) and will be re-randomized after Week 6 to low dose or middle dose of MP-214
  • Drug: MP-214 high dose
    Participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts low or middle dose of MP-214) and will be re-randomized after Week 6 to low dose or middle dose of MP-214
  • Drug: Risperidone
    Participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts low or middle dose of MP-214) and will be re-randomized after Week 6 to low dose or middle dose of MP-214
  • Experimental: MP-214 low dose
    Intervention: Drug: MP-214 low dose
  • Experimental: MP-214 middle dose
    Intervention: Drug: MP-214 middle dose
  • Experimental: MP-214 high dose
    Intervention: Drug: MP-214 high dose
  • Active Comparator: Risperidone
    Intervention: Drug: Risperidone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
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Inclusion Criteria:

  • Written informed consent obtained from the patient before the completion of Study A002-A4
  • Patients who have completed the A002-A4 study

Exclusion Criteria:

  • Patients who are experiencing ongoing, uncontrolled, clinically significant adverse events (AEs), as judged by the investigator (or subinvestigator)
Both
20 Years to 64 Years
No
Contact: Clinical Trials Information Desk cti-inq-ml@ml.mt-pharma.co.jp
Japan,   Korea, Republic of,   Taiwan
 
NCT01626872
A002-A5
Not Provided
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
Not Provided
Not Provided
Mitsubishi Tanabe Pharma Corporation
January 2014

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