NCT01626872

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for phase_2 schizophrenia

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_2 schizophrenia

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

April 12, 2021

Completed
Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

4.1 years

First QC Date

June 19, 2012

Results QC Date

January 11, 2021

Last Update Submit

December 15, 2025

Conditions

Schizophrenia

Keywords

SchizophreniaAntipsychotic AgentsMental DisorderPsychotropic DrugsDopamine AgentsRisperidoneCentral Nervous System Agents

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    The Numbers show Subjects with at least one Adverse Event

    Up to 60 weeks (Treatment Period (48 weeks) and Follow-up Period (12 weeks))

Study Arms (4)

MP-214 3mg

EXPERIMENTAL
Drug: MP-214 3mg

MP-214 6mg

EXPERIMENTAL
Drug: MP-214 6mg

MP-214 9mg

EXPERIMENTAL
Drug: MP-214 9mg

Risperidone 4mg

ACTIVE COMPARATOR
Drug: Risperidone 4mg

Interventions

MP-214 3mgDRUG

In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts 3mg or 6mg of MP-214). In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).

MP-214 3mg
MP-214 6mgDRUG

In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts 3mg or 6mg of MP-214). In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).

MP-214 6mg
MP-214 9mgDRUG

In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts 3mg or 6mg of MP-214). In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).

MP-214 9mg
Risperidone 4mgDRUG

In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4. In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).

Risperidone 4mg

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who are experiencing ongoing, uncontrolled, clinically significant adverse events (AEs), as judged by the investigator (or subinvestigator)
  • The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Taipei, Taiwan

Location

MeSH Terms

Conditions

SchizophreniaMental Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Clinical Trials, Information Desk
Organization
Tanabe Pharma Corporation
cti-inq-ml.JP@ml.tanabe-pharma.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2012

First Posted

June 25, 2012

Study Start

September 1, 2012

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

January 5, 2026

Results First Posted

April 12, 2021

Record last verified: 2025-12

Locations

JP(1)KR(1)TW(1)