Trial Outcomes & Findings for A Long-Term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia (NCT NCT01625897)
NCT ID: NCT01625897
Last Updated: 2026-01-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
125 participants
Primary outcome timeframe
Up to 60 weeks
Results posted on
2026-01-05
Participant Flow
Participant milestones
| Measure |
MP-214 1.5-9mg
Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214
|
Risperidone 2-12mg
Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
42
|
|
Overall Study
COMPLETED
|
31
|
28
|
|
Overall Study
NOT COMPLETED
|
52
|
14
|
Reasons for withdrawal
| Measure |
MP-214 1.5-9mg
Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214
|
Risperidone 2-12mg
Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone
|
|---|---|---|
|
Overall Study
Adverse Event
|
27
|
10
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
25
|
3
|
Baseline Characteristics
A Long-Term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia
Baseline characteristics by cohort
| Measure |
MP-214 1.5-9mg
n=83 Participants
Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214
|
Risperidone 2-12mg
n=42 Participants
Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>=20 and <65 years
|
66 Participants
n=9667 Participants
|
32 Participants
n=6597 Participants
|
98 Participants
n=16264 Participants
|
|
Age, Customized
>=65 and <74 years
|
17 Participants
n=9667 Participants
|
10 Participants
n=6597 Participants
|
27 Participants
n=16264 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=9667 Participants
|
18 Participants
n=6597 Participants
|
62 Participants
n=16264 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=9667 Participants
|
24 Participants
n=6597 Participants
|
63 Participants
n=16264 Participants
|
PRIMARY outcome
Timeframe: Up to 60 weeksOutcome measures
| Measure |
MP-214 1.5-9mg
n=83 Participants
Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214
|
Risperidone 2-12mg
n=42 Participants
Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone
|
|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
|
78 Participants
|
42 Participants
|
Adverse Events
MP-214 1.5-9mg
Serious events: 13 serious events
Other events: 72 other events
Deaths: 0 deaths
Risperidone 2-12mg
Serious events: 4 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MP-214 1.5-9mg
n=83 participants at risk
Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214
|
Risperidone 2-12mg
n=42 participants at risk
Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone
|
|---|---|---|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/83
|
2.4%
1/42
|
|
Infections and infestations
Diverticulitis
|
1.2%
1/83
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
1.2%
1/83
|
0.00%
0/42
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
1.2%
1/83
|
0.00%
0/42
|
|
Nervous system disorders
Brain stem haemorrhage
|
1.2%
1/83
|
0.00%
0/42
|
|
Psychiatric disorders
Schizophrenia
|
10.8%
9/83
|
7.1%
3/42
|
Other adverse events
| Measure |
MP-214 1.5-9mg
n=83 participants at risk
Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214
|
Risperidone 2-12mg
n=42 participants at risk
Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone
|
|---|---|---|
|
Endocrine disorders
Hyperprolactinaemia
|
7.2%
6/83
|
38.1%
16/42
|
|
Gastrointestinal disorders
Constipation
|
8.4%
7/83
|
7.1%
3/42
|
|
Gastrointestinal disorders
Dental caries
|
2.4%
2/83
|
9.5%
4/42
|
|
Gastrointestinal disorders
Diarrhoea
|
7.2%
6/83
|
4.8%
2/42
|
|
Gastrointestinal disorders
Nausea
|
18.1%
15/83
|
11.9%
5/42
|
|
Gastrointestinal disorders
Vomiting
|
9.6%
8/83
|
7.1%
3/42
|
|
General disorders
Malaise
|
3.6%
3/83
|
9.5%
4/42
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
9.6%
8/83
|
0.00%
0/42
|
|
Infections and infestations
Influenza
|
1.2%
1/83
|
7.1%
3/42
|
|
Infections and infestations
Nasopharyngitis
|
31.3%
26/83
|
33.3%
14/42
|
|
Investigations
Blood creatine phosphokinase increased
|
9.6%
8/83
|
9.5%
4/42
|
|
Investigations
Blood prolactin increased
|
10.8%
9/83
|
28.6%
12/42
|
|
Investigations
Blood urine present
|
6.0%
5/83
|
2.4%
1/42
|
|
Investigations
Weight increased
|
7.2%
6/83
|
14.3%
6/42
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.4%
7/83
|
9.5%
4/42
|
|
Nervous system disorders
Akathisia
|
6.0%
5/83
|
19.0%
8/42
|
|
Nervous system disorders
Headache
|
6.0%
5/83
|
11.9%
5/42
|
|
Nervous system disorders
Parkinsonism
|
2.4%
2/83
|
14.3%
6/42
|
|
Nervous system disorders
Somnolence
|
9.6%
8/83
|
11.9%
5/42
|
|
Nervous system disorders
Insomnia
|
16.9%
14/83
|
28.6%
12/42
|
|
Nervous system disorders
Schizophrenia
|
33.7%
28/83
|
26.2%
11/42
|
|
Nervous system disorders
Suicidal ideation
|
3.6%
3/83
|
9.5%
4/42
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/83
|
7.1%
3/42
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.6%
3/83
|
7.1%
3/42
|
|
Vascular disorders
Hypertension
|
7.2%
6/83
|
2.4%
1/42
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER