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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01626872
First Posted: June 25, 2012
Last Update Posted: April 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
  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: Quadruple (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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: June 19, 2012
First Posted: June 25, 2012
Last Update Posted: April 6, 2017
Last Verified: April 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