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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01626872
First received: June 19, 2012
Last updated: April 5, 2017
Last verified: April 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 ]

Enrollment: 254
Study Start Date: June 2012
Study Completion Date: October 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
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   (Adult)
Sexes Eligible for Study:   All
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

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

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: April 5, 2017

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
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 25, 2017