Safety and Efficacy of MP-214 in Patients With Schizophrenia

• Sponsor: Mitsubishi Tanabe Pharma Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01625000
• Collaborator: (none)
• Enrollment: 512
• Locations: 3
• Arms: 5
• Duration (Months): 41
• Patients Per Site: 170.7
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214 relative to placebo in patients with acute exacerbation of schizophrenia.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: MP-214 3mg; Drug: MP-214 6mg; Drug: MP-214 9mg; Drug: Risperidone 4mg; Drug: Placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 512 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Placebo-Controlled Study of MP-214 in Patients With Schizophrenia
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MP-214 3mg	Drug: MP-214 3mg; Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.
Experimental: MP-214 6mg	Drug: MP-214 6mg; Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.
Experimental: MP-214 9mg	Drug: MP-214 9mg; Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.
Active Comparator: Risperidone 4mg	Drug: Risperidone 4mg; Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
Placebo Comparator: Placebo	Drug: Placebo; Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.

Outcome Measures

Primary Outcome Measures

1. Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 [Baseline and Week 6]

   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.

Secondary Outcome Measures

1. Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6 [Baseline and Week 6]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Written informed consent obtained from the patient before the initiation of any study-specific procedures

• Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia

• Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria:

• Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Sapporo	Hokkaido	Japan
2		Seoul		Korea, Republic of
3		Taipei		Taiwan

Sponsors and Collaborators

• Mitsubishi Tanabe Pharma Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mitsubishi Tanabe Pharma Corporation
• ClinicalTrials.gov Identifier: NCT01625000
• Other Study ID Numbers: A002-A4
• First Posted: Jun 21, 2012
• Last Update Posted: Apr 12, 2021
• Last Verified: Apr 1, 2021

• Keywords provided by Mitsubishi Tanabe Pharma Corporation: Schizophrenia; Antipsychotic Agents; Acute Schizophrenia; Mental Disorder; Psychotropic Drugs; Dopamine Agents; Risperidone; Central Nervous System Agents
• Additional relevant MeSH terms: Schizophrenia; Risperidone

Study Results

Participant Flow

Pre-assignment Detail	Four subjects withdrew from the study before the start of the study medication after being assigned to the treatment.

Arm/Group Title	MP-214 3mg	MP-214 6mg	MP-214 9mg	Risperidone 4mg	Placebo
Arm/Group Description	MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.	MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.	MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.	Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.	Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
Period Title: Overall Study
STARTED	126	133	67	56	126
COMPLETED	74	81	34	37	71
NOT COMPLETED	52	52	33	19	55

Baseline Characteristics

Arm/Group Title	MP-214 3mg	MP-214 6mg	MP-214 9mg	Risperidone 4mg	Placebo	Total
Arm/Group Description	MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.	MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.	MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.	Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.	Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.	Total of all reporting groups
Overall Participants	126	133	67	56	126	508
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.6 (10.6)	40.2 (11.4)	43.0 (9.7)	39.5 (10.2)	40.1 (11.1)	40.6 (10.8)
Sex: Female, Male (Count of Participants)
Female	60 47.6%	60 45.1%	34 50.7%	25 44.6%	66 52.4%	245 48.2%
Male	66 52.4%	73 54.9%	33 49.3%	31 55.4%	60 47.6%	263 51.8%

Outcome Measures

1. Primary Outcome

Title	Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
Description	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.
Time Frame	Baseline and Week 6

Outcome Measure Data

Analysis Population Description

For OC (Observed Case) analysis, the Missing Values were Not included.

Arm/Group Title	MP-214 3mg	MP-214 6mg	MP-214 9mg	Risperidone 4mg	Placebo
Arm/Group Description	MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.	MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.	MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.	Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.	Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
Measure Participants	78	80	36	36	71
Least Squares Mean (Standard Error) [units on a scale]	-10.4 (2.0)	-13.8 (2.0)	-14.0 (2.9)	-20.2 (3.0)	-9.5 (2.1)

2. Secondary Outcome

Title	Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6
Description	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).
Time Frame	Baseline and Week 6

Outcome Measure Data

Analysis Population Description

For OC (Observed Case) analysis, the Missing Values were Not included.

Arm/Group Title	MP-214 3mg	MP-214 6mg	MP-214 9mg	Risperidone 4mg	Placebo
Arm/Group Description	MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.	MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.	MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.	Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.	Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
Measure Participants	78	80	36	36	71
Least Squares Mean (Standard Error) [units on a scale]	-0.7 (0.1)	-0.8 (0.1)	-0.7 (0.2)	-1.2 (0.2)	-0.6 (0.1)

Adverse Events

Arm/Group Title	MP-214 3mg		MP-214 6mg		MP-214 9mg		Risperidone 4mg		Placebo
Arm/Group Description	MP-214 3mg: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.		MP-214 6mg: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.		MP-214 9mg: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.		Risperidone 4mg: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.		Placebo: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
All Cause Mortality
	MP-214 3mg		MP-214 6mg		MP-214 9mg		Risperidone 4mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	MP-214 3mg		MP-214 6mg		MP-214 9mg		Risperidone 4mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/126 (9.5%)		16/133 (12%)		4/67 (6%)		2/56 (3.6%)		14/126 (11.1%)
General disorders
Sudden death	0/126 (0%)		1/133 (0.8%)		0/67 (0%)		0/56 (0%)		0/126 (0%)
Infections and infestations
Infection masked	0/126 (0%)		0/133 (0%)		0/67 (0%)		0/56 (0%)		1/126 (0.8%)
Pneumonia	1/126 (0.8%)		0/133 (0%)		0/67 (0%)		0/56 (0%)		0/126 (0%)
Investigations
Blood creatine phosphokinase increased	0/126 (0%)		1/133 (0.8%)		0/67 (0%)		0/56 (0%)		0/126 (0%)
Musculoskeletal and connective tissue disorders
Rhabdomyolysis	0/126 (0%)		1/133 (0.8%)		0/67 (0%)		0/56 (0%)		0/126 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/126 (0.8%)		0/133 (0%)		0/67 (0%)		0/56 (0%)		0/126 (0%)
Nervous system disorders
Akathisia	0/126 (0%)		0/133 (0%)		0/67 (0%)		1/56 (1.8%)		0/126 (0%)
Altered state of consciousness	0/126 (0%)		0/133 (0%)		0/67 (0%)		0/56 (0%)		1/126 (0.8%)
Extrapyramidal disorder	0/126 (0%)		0/133 (0%)		0/67 (0%)		1/56 (1.8%)		0/126 (0%)
Neuroleptic malignant syndrome	0/126 (0%)		0/133 (0%)		0/67 (0%)		0/56 (0%)		1/126 (0.8%)
Psychiatric disorders
Agitation	0/126 (0%)		0/133 (0%)		1/67 (1.5%)		0/56 (0%)		0/126 (0%)
Schizophrenia	9/126 (7.1%)		14/133 (10.5%)		3/67 (4.5%)		0/56 (0%)		12/126 (9.5%)
Suicidal behaviour	0/126 (0%)		0/133 (0%)		1/67 (1.5%)		0/56 (0%)		0/126 (0%)
Suicidal ideation	0/126 (0%)		0/133 (0%)		1/67 (1.5%)		0/56 (0%)		0/126 (0%)
Suicide attempt	1/126 (0.8%)		0/133 (0%)		0/67 (0%)		1/56 (1.8%)		1/126 (0.8%)
Other (Not Including Serious) Adverse Events
	MP-214 3mg		MP-214 6mg		MP-214 9mg		Risperidone 4mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	95/126 (75.4%)		100/133 (75.2%)		52/67 (77.6%)		36/56 (64.3%)		72/126 (57.1%)
Gastrointestinal disorders
Constipation	21/126 (16.7%)		20/133 (15%)		12/67 (17.9%)		5/56 (8.9%)		15/126 (11.9%)
Diarrhoea	6/126 (4.8%)		8/133 (6%)		4/67 (6%)		1/56 (1.8%)		3/126 (2.4%)
Dyspepsia	3/126 (2.4%)		4/133 (3%)		4/67 (6%)		2/56 (3.6%)		3/126 (2.4%)
Nausea	15/126 (11.9%)		9/133 (6.8%)		7/67 (10.4%)		4/56 (7.1%)		5/126 (4%)
Vomiting	18/126 (14.3%)		12/133 (9%)		5/67 (7.5%)		1/56 (1.8%)		7/126 (5.6%)
Infections and infestations
Nasopharyngitis	10/126 (7.9%)		15/133 (11.3%)		9/67 (13.4%)		8/56 (14.3%)		6/126 (4.8%)
Injury, poisoning and procedural complications
Contusion	4/126 (3.2%)		3/133 (2.3%)		2/67 (3%)		2/56 (3.6%)		8/126 (6.3%)
Investigations
Blood creatine phosphokinase increased	7/126 (5.6%)		5/133 (3.8%)		0/67 (0%)		2/56 (3.6%)		5/126 (4%)
Liver function test abnormal	1/126 (0.8%)		1/133 (0.8%)		5/67 (7.5%)		0/56 (0%)		1/126 (0.8%)
Metabolism and nutrition disorders
Decreased appetite	6/126 (4.8%)		7/133 (5.3%)		2/67 (3%)		0/56 (0%)		4/126 (3.2%)
Musculoskeletal and connective tissue disorders
Myalgia	2/126 (1.6%)		1/133 (0.8%)		2/67 (3%)		3/56 (5.4%)		1/126 (0.8%)
Nervous system disorders
Akathisia	28/126 (22.2%)		19/133 (14.3%)		2/67 (3%)		9/56 (16.1%)		10/126 (7.9%)
Dizziness	4/126 (3.2%)		6/133 (4.5%)		3/67 (4.5%)		4/56 (7.1%)		4/126 (3.2%)
Extrapyramidal disorder	11/126 (8.7%)		19/133 (14.3%)		11/67 (16.4%)		6/56 (10.7%)		12/126 (9.5%)
Headache	19/126 (15.1%)		14/133 (10.5%)		7/67 (10.4%)		4/56 (7.1%)		14/126 (11.1%)
Somnolence	3/126 (2.4%)		2/133 (1.5%)		5/67 (7.5%)		1/56 (1.8%)		3/126 (2.4%)
Tremor	7/126 (5.6%)		13/133 (9.8%)		1/67 (1.5%)		0/56 (0%)		4/126 (3.2%)
Psychiatric disorders
Insomnia	12/126 (9.5%)		16/133 (12%)		5/67 (7.5%)		2/56 (3.6%)		9/126 (7.1%)
Restlessness	3/126 (2.4%)		5/133 (3.8%)		4/67 (6%)		3/56 (5.4%)		5/126 (4%)
Schizophrenia	16/126 (12.7%)		15/133 (11.3%)		13/67 (19.4%)		7/56 (12.5%)		23/126 (18.3%)
Vascular disorders
Hypertension	0/126 (0%)		5/133 (3.8%)		6/67 (9%)		0/56 (0%)		2/126 (1.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.