SchizophreniaPhase 2/3NCT01626872
Long-Term Study of MP-214 in Patients With Schizophrenia
A Phase 2/3 study testing MP-214 3mg, MP-214 6mg and MP-214 9mg in people with Schizophrenia, run by Tanabe Pharma Corporation at 3 sites in 3 countries.
Trial summary
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- MP-214 3mg, MP-214 6mg and MP-214 9mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Sep 2012to Oct 2016
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained from the patient before the completion of Study A002-A4
- Patients who have completed the A002-A4 study
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Long-Term Extension Study of MP-214 in Patients With Schizophrenia
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- MP-214 3mg, MP-214 6mg, MP-214 9mg, Risperidone 4mg
- Keywords
- Schizophrenia, Antipsychotic Agents, Mental Disorder, Psychotropic Drugs, Dopamine Agents, Risperidone, Central Nervous System Agents
- Medical subject headings
- Schizophrenia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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 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).
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).
| Study group | Role | What they receive |
|---|---|---|
| MP-214 3mg | Experimental | Not described Receives: Drug: MP-214 3mg |
| MP-214 6mg | Experimental | Not described Receives: Drug: MP-214 6mg |
| MP-214 9mg | Experimental | Not described Receives: Drug: MP-214 9mg |
| Risperidone 4mg | Active comparator | Not described Receives: Drug: Risperidone 4mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
The Numbers show Subjects with at least one Adverse Event
Measured: Up to 60 weeks (Treatment Period (48 weeks) and Follow-up Period (12 weeks))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626872
- Sponsor's protocol ID
- A002-A5
- Status last verified
- Dec 2025
- First submitted
- 19 Jun 2012
- Last updated
- 5 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Extension Study of MP-214 in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01626872
- Acronym / sponsor ID
- A002-A5
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Antipsychotic Agents, Mental Disorder, Psychotropic Drugs, Dopamine Agents, Risperidone, Central Nervous System Agents
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 25 Jun 2012 (estimated)
- Results
- Posted 12 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent obtained from the patient before the completion of Study A002-A4
- Patients who have completed the A002-A4 study
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MP-214 3mgIn 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). | Drug | MP-214 3mg |
| MP-214 6mgIn 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). | Drug | MP-214 6mg |
| MP-214 9mgIn 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). | Drug | MP-214 9mg |
| Risperidone 4mgIn 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). | Drug | Risperidone 4mg |
Primary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 60 weeks (Treatment Period (48 weeks) and Follow-up Period (12 weeks))
The Numbers show Subjects with at least one Adverse Event
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MP-214 3mg, MP-214 6mg and MP-214 9mg in people with Schizophrenia, run by Tanabe Pharma Corporation at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (time frame: Up to 60 weeks (Treatment Period (48 weeks) and Follow-up Period (12 weeks))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.