Trial Outcomes & Findings for Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia (NCT NCT00862992)
NCT ID: NCT00862992
Last Updated: 2026-01-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Up to 7 weeks
Results posted on
2026-01-05
Participant Flow
Participant milestones
| Measure |
Cariprazine 3 mg
|
Cariprazine 6 mg
|
Cariprazine 12.5 mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
12
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
3
|
Reasons for withdrawal
| Measure |
Cariprazine 3 mg
|
Cariprazine 6 mg
|
Cariprazine 12.5 mg
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
Baseline Characteristics
Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Cariprazine 3 mg
n=12 Participants
|
Cariprazine 6 mg
n=10 Participants
|
Cariprazine 12.5 mg
n=12 Participants
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
0 Participants
n=31 Participants
|
|
Age, Customized
>=18 and =<30 years
|
2 Participants
n=9667 Participants
|
2 Participants
n=6597 Participants
|
2 Participants
n=16264 Participants
|
6 Participants
n=31 Participants
|
|
Age, Customized
>=31 and =<40 years
|
2 Participants
n=9667 Participants
|
4 Participants
n=6597 Participants
|
3 Participants
n=16264 Participants
|
9 Participants
n=31 Participants
|
|
Age, Customized
>=41 and =<55 years
|
6 Participants
n=9667 Participants
|
3 Participants
n=6597 Participants
|
5 Participants
n=16264 Participants
|
14 Participants
n=31 Participants
|
|
Age, Customized
>55 years
|
2 Participants
n=9667 Participants
|
1 Participants
n=6597 Participants
|
2 Participants
n=16264 Participants
|
5 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=9667 Participants
|
4 Participants
n=6597 Participants
|
4 Participants
n=16264 Participants
|
14 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=9667 Participants
|
6 Participants
n=6597 Participants
|
8 Participants
n=16264 Participants
|
20 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Up to 7 weeksOutcome measures
| Measure |
Cariprazine 3 mg
n=12 Participants
|
Cariprazine 6 mg
n=10 Participants
|
Cariprazine 12.5 mg
n=12 Participants
|
|---|---|---|---|
|
Number of Participants With Adverse Event and Adverse Drug Reaction
Number of Participants With Adverse event
|
9 Participants
|
9 Participants
|
11 Participants
|
|
Number of Participants With Adverse Event and Adverse Drug Reaction
Number of Participants With Adverse drug Reaction
|
5 Participants
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.Population: Of the 34 participants, 7 subjects who prematurely discontinued during the titration period, 1 subject used prohibited concomitant medication and 1 subject did not take the test product on Day 12 of the fixed-dose period were excluded from the pharmacokinetic analysis.
Outcome measures
| Measure |
Cariprazine 3 mg
n=9 Participants
|
Cariprazine 6 mg
n=8 Participants
|
Cariprazine 12.5 mg
n=8 Participants
|
|---|---|---|---|
|
Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14
Unchanged MP-214
|
9.19 ng/mL
Standard Deviation 3.47
|
19.43 ng/mL
Standard Deviation 4.80
|
36.39 ng/mL
Standard Deviation 8.53
|
|
Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14
M7 (desmethyl cariprazine)
|
3.14 ng/mL
Standard Deviation 1.26
|
5.83 ng/mL
Standard Deviation 1.87
|
11.37 ng/mL
Standard Deviation 3.00
|
|
Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14
M6 (didesmethyl cariprazine)
|
13.79 ng/mL
Standard Deviation 5.74
|
28.08 ng/mL
Standard Deviation 14.52
|
54.99 ng/mL
Standard Deviation 14.97
|
SECONDARY outcome
Timeframe: Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.Population: Of the 34 participants, 7 subjects who prematurely discontinued during the titration period, 1 subject used prohibited concomitant medication and 1 subject did not take the test product on Day 12 of the fixed-dose period were excluded from the pharmacokinetic analysis.
Outcome measures
| Measure |
Cariprazine 3 mg
n=9 Participants
|
Cariprazine 6 mg
n=8 Participants
|
Cariprazine 12.5 mg
n=8 Participants
|
|---|---|---|---|
|
Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14
M6 (didesmethyl cariprazine)
|
4.79 hour
Standard Deviation 2.23
|
5.37 hour
Standard Deviation 2.14
|
5.22 hour
Standard Deviation 2.08
|
|
Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14
Unchanged MP-214
|
3.71 hour
Standard Deviation 0.99
|
3.48 hour
Standard Deviation 1.11
|
3.22 hour
Standard Deviation 0.45
|
|
Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14
M7 (desmethyl cariprazine)
|
5.25 hour
Standard Deviation 1.99
|
5.10 hour
Standard Deviation 1.94
|
4.36 hour
Standard Deviation 1.80
|
SECONDARY outcome
Timeframe: Pre-dose, 3, 4, 6, 8, 24, 48, 72, 96 and 168 hours post-dose of Day 14.Population: Of the 34 participants, 7 subjects who prematurely discontinued during the titration period, 1 subject used prohibited concomitant medication and 1 subject did not take the test product on Day 12 of the fixed-dose period were excluded from the pharmacokinetic analysis.
Outcome measures
| Measure |
Cariprazine 3 mg
n=9 Participants
|
Cariprazine 6 mg
n=8 Participants
|
Cariprazine 12.5 mg
n=8 Participants
|
|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Last of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14
Unchanged MP-214
|
298.36 ng*hr/mL
Standard Deviation 128.04
|
522.38 ng*hr/mL
Standard Deviation 194.61
|
1017.96 ng*hr/mL
Standard Deviation 419.24
|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Last of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14
M7 (desmethyl cariprazine)
|
135.25 ng*hr/mL
Standard Deviation 64.80
|
232.38 ng*hr/mL
Standard Deviation 113.31
|
437.64 ng*hr/mL
Standard Deviation 131.76
|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Last of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14
M6 (didesmethyl cariprazine)
|
1884.24 ng*hr/mL
Standard Deviation 785.73
|
3397.12 ng*hr/mL
Standard Deviation 2395.44
|
5950.73 ng*hr/mL
Standard Deviation 1928.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at baseline, and on Day 14 or a last observation carried forward (LOCF)PANSS score is a 30-item rating scale to assess both the positive and negative symptom syndromes of patients with schizophrenia. Each item is scored on a 7-point scale, from 1 (absent) to 7 (extreme). The PANSS total score of the 30 PANSS items ranges from 30 to 210. High scores indicate greater severity of symptoms.
Outcome measures
| Measure |
Cariprazine 3 mg
n=12 Participants
|
Cariprazine 6 mg
n=10 Participants
|
Cariprazine 12.5 mg
n=12 Participants
|
|---|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 14 (Last Observation Carried Forward; LOCF)
|
-0.2 units on a scale
Standard Deviation 12.8
|
-0.6 units on a scale
Standard Deviation 15.6
|
-3.9 units on a scale
Standard Deviation 10.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at baseline, and on Day 14 or a last observation carried forward (LOCF)CGI-S is a 7-point scale to assess the global severity of the participant's illness. CGI-S scores range from 1 (normal, not ill at all) to 7 (extremely ill).
Outcome measures
| Measure |
Cariprazine 3 mg
n=12 Participants
|
Cariprazine 6 mg
n=10 Participants
|
Cariprazine 12.5 mg
n=12 Participants
|
|---|---|---|---|
|
Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Day 14 (Last Observation Carried Forward; LOCF)
|
0.3 units on a scale
Standard Deviation 0.8
|
-0.1 units on a scale
Standard Deviation 0.9
|
-0.1 units on a scale
Standard Deviation 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: on Day 14 or a last observation carried forward (LOCF)CGI-I is a 7-point scale to assess the global improvement of the participant's illness relative to baseline. CGI-I scores range from 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
Cariprazine 3 mg
n=12 Participants
|
Cariprazine 6 mg
n=10 Participants
|
Cariprazine 12.5 mg
n=12 Participants
|
|---|---|---|---|
|
The Clinical Global Impression-Improvement (CGI-I) Score at Day 14 (Last Observation Carried Forward; LOCF)
|
4.1 units on a scale
Standard Deviation 1.3
|
3.7 units on a scale
Standard Deviation 1.2
|
3.8 units on a scale
Standard Deviation 1.1
|
Adverse Events
Cariprazine 3 mg
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Cariprazine 6 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Cariprazine 12.5 mg
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cariprazine 3 mg
n=12 participants at risk
|
Cariprazine 6 mg
n=10 participants at risk
|
Cariprazine 12.5 mg
n=12 participants at risk
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Tibia fracture
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/12
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/12
|
10.0%
1/10
|
0.00%
0/12
|
|
Nervous system disorders
Neuroleptic malignant syndrome
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Psychiatric disorders
Schizophrenia
|
16.7%
2/12
|
10.0%
1/10
|
8.3%
1/12
|
Other adverse events
| Measure |
Cariprazine 3 mg
n=12 participants at risk
|
Cariprazine 6 mg
n=10 participants at risk
|
Cariprazine 12.5 mg
n=12 participants at risk
|
|---|---|---|---|
|
Social circumstances
Poor personal hygiene
|
0.00%
0/12
|
10.0%
1/10
|
0.00%
0/12
|
|
Vascular disorders
Orthostatic hypotension
|
8.3%
1/12
|
10.0%
1/10
|
8.3%
1/12
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/12
|
10.0%
1/10
|
0.00%
0/12
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/12
|
10.0%
1/10
|
0.00%
0/12
|
|
Eye disorders
Dry eye
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/12
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12
|
10.0%
1/10
|
8.3%
1/12
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12
|
10.0%
1/10
|
25.0%
3/12
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/12
|
10.0%
1/10
|
0.00%
0/12
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/12
|
10.0%
1/10
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12
|
10.0%
1/10
|
0.00%
0/12
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12
|
20.0%
2/10
|
0.00%
0/12
|
|
General disorders
Feeling abnormal
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/12
|
|
General disorders
Malaise
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/12
|
|
General disorders
Pyrexia
|
0.00%
0/12
|
0.00%
0/10
|
16.7%
2/12
|
|
General disorders
Thirst
|
0.00%
0/12
|
0.00%
0/10
|
16.7%
2/12
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
2/12
|
30.0%
3/10
|
8.3%
1/12
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12
|
10.0%
1/10
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12
|
10.0%
1/10
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Hand fracture
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Injury, poisoning and procedural complications
Skin laceration
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Thermal burn
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/12
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12
|
0.00%
0/10
|
25.0%
3/12
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12
|
10.0%
1/10
|
16.7%
2/12
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Investigations
Blood creatine phosphokinase increased
|
8.3%
1/12
|
10.0%
1/10
|
25.0%
3/12
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Investigations
Blood potassium increased
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Investigations
Blood pressure decreased
|
0.00%
0/12
|
10.0%
1/10
|
0.00%
0/12
|
|
Investigations
Blood pressure increased
|
0.00%
0/12
|
10.0%
1/10
|
0.00%
0/12
|
|
Investigations
Blood prolactin increased
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Investigations
Blood uric acid increased
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Investigations
Blood urine present
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/12
|
|
Investigations
Glucose urine present
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Investigations
Hepatic enzyme increased
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/12
|
|
Investigations
White blood cell count decreased
|
0.00%
0/12
|
10.0%
1/10
|
0.00%
0/12
|
|
Investigations
White blood cell count increased
|
0.00%
0/12
|
0.00%
0/10
|
25.0%
3/12
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/12
|
0.00%
0/10
|
16.7%
2/12
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12
|
10.0%
1/10
|
0.00%
0/12
|
|
Nervous system disorders
Akathisia
|
8.3%
1/12
|
10.0%
1/10
|
25.0%
3/12
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Nervous system disorders
Headache
|
8.3%
1/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/12
|
10.0%
1/10
|
8.3%
1/12
|
|
Nervous system disorders
Sleep paralysis
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/12
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Nervous system disorders
Tremor
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Psychiatric disorders
Insomnia
|
33.3%
4/12
|
30.0%
3/10
|
8.3%
1/12
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Renal and urinary disorders
Pollakiuria
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/12
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/12
|
10.0%
1/10
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/12
|
10.0%
1/10
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Eczema
|
8.3%
1/12
|
0.00%
0/10
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/12
|
0.00%
0/10
|
8.3%
1/12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER