Trial Outcomes & Findings for Long-Term Study of MP-214 in Patients With Schizophrenia (NCT NCT01626872)
NCT ID: NCT01626872
Last Updated: 2026-01-05
Results Overview
The Numbers show Subjects with at least one Adverse Event
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
254 participants
Primary outcome timeframe
Up to 60 weeks (Treatment Period (48 weeks) and Follow-up Period (12 weeks))
Results posted on
2026-01-05
Participant Flow
Six patients who did not receive MP-214 during the open-label phase were excluded from the analysis population.
Participant milestones
| Measure |
MP-214 3mg
|
MP-214 6mg
|
MP-214 9mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
81
|
109
|
58
|
|
Overall Study
COMPLETED
|
29
|
43
|
34
|
|
Overall Study
NOT COMPLETED
|
52
|
66
|
24
|
Reasons for withdrawal
| Measure |
MP-214 3mg
|
MP-214 6mg
|
MP-214 9mg
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
13
|
9
|
6
|
|
Overall Study
Withdrawal by Subject
|
19
|
27
|
8
|
|
Overall Study
Adverse Event (including Death)
|
20
|
28
|
8
|
|
Overall Study
Protocol Violation (including Pregnancy)
|
0
|
2
|
2
|
Baseline Characteristics
Long-Term Study of MP-214 in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
MP-214 3mg
n=81 Participants
|
MP-214 6mg
n=109 Participants
|
MP-214 9mg
n=58 Participants
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 11.1 • n=9 Participants
|
40.8 years
STANDARD_DEVIATION 11.3 • n=32 Participants
|
42.5 years
STANDARD_DEVIATION 8.9 • n=18 Participants
|
40.3 years
STANDARD_DEVIATION 10.8 • n=78 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=9 Participants
|
56 Participants
n=32 Participants
|
20 Participants
n=18 Participants
|
116 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=9 Participants
|
53 Participants
n=32 Participants
|
38 Participants
n=18 Participants
|
132 Participants
n=78 Participants
|
PRIMARY outcome
Timeframe: Up to 60 weeks (Treatment Period (48 weeks) and Follow-up Period (12 weeks))The Numbers show Subjects with at least one Adverse Event
Outcome measures
| Measure |
MP-214 3mg
n=81 Participants
|
MP-214 6mg
n=109 Participants
|
MP-214 9mg
n=58 Participants
|
|---|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
|
67 Participants
|
92 Participants
|
50 Participants
|
Adverse Events
MP-214 3mg
Serious events: 14 serious events
Other events: 55 other events
Deaths: 0 deaths
MP-214 6mg
Serious events: 33 serious events
Other events: 72 other events
Deaths: 0 deaths
MP-214 9mg
Serious events: 14 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MP-214 3mg
n=81 participants at risk
|
MP-214 6mg
n=109 participants at risk
|
MP-214 9mg
n=58 participants at risk
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.2%
1/81
|
0.00%
0/109
|
0.00%
0/58
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.2%
1/81
|
0.00%
0/109
|
0.00%
0/58
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/81
|
0.92%
1/109
|
0.00%
0/58
|
|
Injury, poisoning and procedural complications
Scar
|
1.2%
1/81
|
0.00%
0/109
|
0.00%
0/58
|
|
Injury, poisoning and procedural complications
Skin scar contracture
|
1.2%
1/81
|
0.00%
0/109
|
0.00%
0/58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/81
|
0.92%
1/109
|
0.00%
0/58
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/81
|
0.00%
0/109
|
1.7%
1/58
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/81
|
0.00%
0/109
|
1.7%
1/58
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/81
|
0.92%
1/109
|
3.4%
2/58
|
|
Psychiatric disorders
Mania
|
1.2%
1/81
|
0.00%
0/109
|
0.00%
0/58
|
|
Psychiatric disorders
Psychiatric symptom
|
0.00%
0/81
|
0.92%
1/109
|
0.00%
0/58
|
|
Psychiatric disorders
Schizophrenia
|
11.1%
9/81
|
23.9%
26/109
|
19.0%
11/58
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
1.2%
1/81
|
0.92%
1/109
|
1.7%
1/58
|
|
Psychiatric disorders
Somatoform disorder
|
1.2%
1/81
|
0.00%
0/109
|
0.00%
0/58
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/81
|
0.92%
1/109
|
0.00%
0/58
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/81
|
1.8%
2/109
|
0.00%
0/58
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/81
|
0.92%
1/109
|
0.00%
0/58
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/81
|
0.92%
1/109
|
0.00%
0/58
|
Other adverse events
| Measure |
MP-214 3mg
n=81 participants at risk
|
MP-214 6mg
n=109 participants at risk
|
MP-214 9mg
n=58 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.2%
1/81
|
2.8%
3/109
|
5.2%
3/58
|
|
Gastrointestinal disorders
Constipation
|
11.1%
9/81
|
4.6%
5/109
|
10.3%
6/58
|
|
Gastrointestinal disorders
Dental caries
|
3.7%
3/81
|
0.92%
1/109
|
6.9%
4/58
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
3/81
|
3.7%
4/109
|
8.6%
5/58
|
|
Gastrointestinal disorders
Nausea
|
4.9%
4/81
|
1.8%
2/109
|
6.9%
4/58
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
5/81
|
2.8%
3/109
|
6.9%
4/58
|
|
Infections and infestations
Nasopharyngitis
|
25.9%
21/81
|
11.9%
13/109
|
22.4%
13/58
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/81
|
2.8%
3/109
|
10.3%
6/58
|
|
Injury, poisoning and procedural complications
Contusion
|
3.7%
3/81
|
4.6%
5/109
|
5.2%
3/58
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.2%
1/81
|
0.92%
1/109
|
5.2%
3/58
|
|
Investigations
Blood creatine phosphokinase increased
|
1.2%
1/81
|
6.4%
7/109
|
0.00%
0/58
|
|
Investigations
Weight increased
|
4.9%
4/81
|
10.1%
11/109
|
3.4%
2/58
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
3/81
|
2.8%
3/109
|
6.9%
4/58
|
|
Nervous system disorders
Akathisia
|
18.5%
15/81
|
13.8%
15/109
|
3.4%
2/58
|
|
Nervous system disorders
Dizziness
|
4.9%
4/81
|
5.5%
6/109
|
3.4%
2/58
|
|
Nervous system disorders
Extrapyramidal disorder
|
9.9%
8/81
|
6.4%
7/109
|
6.9%
4/58
|
|
Nervous system disorders
Headache
|
11.1%
9/81
|
6.4%
7/109
|
6.9%
4/58
|
|
Nervous system disorders
Somnolence
|
2.5%
2/81
|
5.5%
6/109
|
1.7%
1/58
|
|
Nervous system disorders
Tremor
|
0.00%
0/81
|
4.6%
5/109
|
6.9%
4/58
|
|
Psychiatric disorders
Anxiety
|
3.7%
3/81
|
6.4%
7/109
|
3.4%
2/58
|
|
Psychiatric disorders
Insomnia
|
4.9%
4/81
|
11.0%
12/109
|
13.8%
8/58
|
|
Psychiatric disorders
Restlessness
|
1.2%
1/81
|
3.7%
4/109
|
5.2%
3/58
|
|
Psychiatric disorders
Schizophrenia
|
14.8%
12/81
|
11.0%
12/109
|
19.0%
11/58
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.2%
1/81
|
0.00%
0/109
|
5.2%
3/58
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.2%
1/81
|
4.6%
5/109
|
10.3%
6/58
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/81
|
0.00%
0/109
|
5.2%
3/58
|
|
Vascular disorders
Hypertension
|
3.7%
3/81
|
3.7%
4/109
|
5.2%
3/58
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER