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CompletedNCT01626872Updated Jan 5, 2026Results posted

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

A Phase 2/3 interventional study of MP-214 3mg and MP-214 6mg in Schizophrenia, sponsored by Tanabe Pharma Corporation. Completed at 3 sites in 3 countries. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-05.

Sponsored by Tanabe Pharma Corporation · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
254
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Schizophrenia

Keywords

  • Schizophrenia
  • Antipsychotic Agents
  • Mental Disorder
  • Psychotropic Drugs
  • Dopamine Agents
  • Risperidone
  • Central Nervous System Agents
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 254 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Tanabe Pharma Corporation is the lead sponsor of 91 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • 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.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
254 participants (actual)

Study arms

  • Experimental
    MP-214 3mg

    Drug: MP-214 3mg

  • Experimental
    MP-214 6mg

    Drug: MP-214 6mg

  • Experimental
    MP-214 9mg

    Drug: MP-214 9mg

  • Active comparator
    Risperidone 4mg

    Drug: Risperidone 4mg

Interventions

  • DrugMP-214 3mg

    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).

  • DrugMP-214 6mg

    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).

  • DrugMP-214 9mg

    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).

  • DrugRisperidone 4mg

    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).

06

What researchers measure

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

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

07

Results

Posted Apr 12, 2021

Participant flow

Participant flow — Overall Study
MilestoneMP-214 3mgMP-214 6mgMP-214 9mg
Started8110958
Completed294334
Not completed526624
Withdrew: Physician decision1396
Withdrew: Withdrawal by subject19278
Withdrew: Adverse event (including death)20288
Withdrew: Protocol violation (including pregnancy)022

Outcome measures

PrimaryNumber of Participants With Adverse Events as a Measure of Safety and Tolerability

The Numbers show Subjects with at least one Adverse Event

Time frame:
Up to 60 weeks (Treatment Period (48 weeks) and Follow-up Period (12 weeks))
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
ParticipantsMP-214 3mgMP-214 6mgMP-214 9mg
Number of Participants With Adverse Events as a Measure of Safety and Tolerability679250

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MP-214 3mg—14/81 (17.3%)55/81 (67.9%)
MP-214 6mg—33/109 (30.3%)72/109 (66.1%)
MP-214 9mg—14/58 (24.1%)42/58 (72.4%)
Most frequent serious events
Showing 10 of 18
Most frequent serious events
EventMP-214 3mgMP-214 6mgMP-214 9mg
SchizophreniaPsychiatric disorders9/8126/10911/58
InsomniaPsychiatric disorders0/811/1092/58
Suicide attemptPsychiatric disorders0/812/1090/58
Abortion spontaneousPregnancy, puerperium and perinatal conditions0/810/1091/58
Completed suicidePsychiatric disorders0/810/1091/58
Schizophrenia, paranoid typePsychiatric disorders1/811/1091/58
Ankle fractureInjury, poisoning and procedural complications1/810/1090/58
Ligament sprainInjury, poisoning and procedural complications1/810/1090/58
ScarInjury, poisoning and procedural complications1/810/1090/58
Skin scar contractureInjury, poisoning and procedural complications1/810/1090/58
Most frequent other events
Showing 10 of 27
Most frequent other events
EventMP-214 3mgMP-214 6mgMP-214 9mg
NasopharyngitisInfections and infestations21/8113/10913/58
SchizophreniaPsychiatric disorders12/8112/10911/58
AkathisiaNervous system disorders15/8115/1092/58
InsomniaPsychiatric disorders4/8112/1098/58
ConstipationGastrointestinal disorders9/815/1096/58
HeadacheNervous system disorders9/817/1094/58
Tinea pedisInfections and infestations0/813/1096/58
EczemaSkin and subcutaneous tissue disorders1/815/1096/58
Weight increasedInvestigations4/8111/1092/58
Extrapyramidal disorderNervous system disorders8/817/1094/58

Baseline characteristics

Age, Continuous
Age, Continuous(years)MP-214 3mgMP-214 6mgMP-214 9mgTotal
Mean38.0 ± 11.140.8 ± 11.342.5 ± 8.940.3 ± 10.8
Sex: Female, Male
Sex: Female, Male(Participants)MP-214 3mgMP-214 6mgMP-214 9mgTotal
Female405620116
Male415338132
08

Study locations

3 sites
  • Sapporo, Hokkaido, Japan
  • Seoul, South Korea
  • Taipei, Taiwan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01626872
Lead sponsor
Tanabe Pharma Corporation
Responsible party
Sponsor
First posted
Jun 25, 2012
Start date
Sep 2012
Primary completion
Oct 2016
Completion
Oct 2016
Results posted
Apr 12, 2021
Last update
Jan 5, 2026
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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