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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 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: July 8, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: MP-214 low dose
Drug: MP-214 middle dose
Drug: MP-214 high dose
Drug: Risperidone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-Term Extension Study of MP-214 in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 60 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: June 2012
Arms Assigned Interventions
Experimental: MP-214 low dose 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
Experimental: MP-214 middle dose 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
Experimental: MP-214 high dose 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
Active Comparator: Risperidone 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

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626872

Contacts
Contact: Clinical Trials Information Desk cti-inq-ml@ml.mt-pharma.co.jp

Locations
Japan
Recruiting
Sapporo, Hokkaido, Japan
Korea, Republic of
Recruiting
Seoul, Korea, Republic of
Taiwan
Recruiting
Taipei, Taiwan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01626872     History of Changes
Other Study ID Numbers: A002-A5
Study First Received: June 19, 2012
Last Updated: July 8, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
Korea: Food and Drug Administration
Taiwan : Food and Drug Administration

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Schizophrenia
Antipsychotic Agents
Mental Disorder
Psychotropic Drugs
Dopamine Agents
Risperidone
Central Nervous System Agents

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014