Trial Outcomes & Findings for A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia (NCT NCT01626885)

Last Updated: 2026-01-06

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

42 participants

Primary outcome timeframe

Up to 60 weeks

Results posted on

2026-01-06

Participant milestones
Measure	MP-214 1.5-9 mg MP-214: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214
Overall Study STARTED	42
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	12

Reasons for withdrawal
Measure	MP-214 1.5-9 mg MP-214: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214
Overall Study Adverse Event	8
Overall Study Withdrawal by Subject	4

A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia

Baseline characteristics by cohort
Measure	MP-214 1.5-9 mg n=42 Participants MP-214: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214
Age, Continuous	40.4 years STANDARD_DEVIATION 10.7 • n=37 Participants
Sex: Female, Male Female	19 Participants n=37 Participants
Sex: Female, Male Male	23 Participants n=37 Participants

Timeframe: Up to 60 weeks

Outcome measures
Measure	MP-214 1.5-9 mg n=42 Participants MP-214: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	42 Participants

Serious events: 2 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events
Measure	MP-214 1.5-9 mg n=42 participants at risk MP-214: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214
Metabolism and nutrition disorders Type 2 diabetes mellitus	2.4% 1/42
Psychiatric disorders Schizophrenia	2.4% 1/42

Other adverse events
Measure	MP-214 1.5-9 mg n=42 participants at risk MP-214: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214
Gastrointestinal disorders Nausea	9.5% 4/42
Gastrointestinal disorders Vomiting	7.1% 3/42
Infections and infestations Nasopharyngitis	42.9% 18/42
Injury, poisoning and procedural complications Contusion	7.1% 3/42
Investigations Alanine aminotransferase increased	11.9% 5/42
Investigations Aspartate aminotransferase increased	7.1% 3/42
Investigations Blood creatine phosphokinase increased	14.3% 6/42
Investigations Gamma-glutamyltransferase increased	7.1% 3/42
Investigations Weight increased	14.3% 6/42
Musculoskeletal and connective tissue disorders Back pain	7.1% 3/42
Nervous system disorders Akathisia	7.1% 3/42
Nervous system disorders Dizziness	7.1% 3/42
Nervous system disorders Extrapyramidal disorder	14.3% 6/42
Nervous system disorders Headache	16.7% 7/42
Nervous system disorders Somnolence	16.7% 7/42
Psychiatric disorders Anxiety	7.1% 3/42
Psychiatric disorders Initial insomnia	7.1% 3/42
Psychiatric disorders Insomnia	11.9% 5/42
Psychiatric disorders Irritability	7.1% 3/42
Psychiatric disorders Schizophrenia	19.0% 8/42
Respiratory, thoracic and mediastinal disorders Asthma	7.1% 3/42

Tanabe Pharma Corporation

Restriction type: OTHER