A Long-Term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia

• Sponsor: Mitsubishi Tanabe Pharma Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01625897
• Collaborator: (none)
• Enrollment: 125
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with chronic phase or elderly schizophrenia.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: MP-214; Drug: Risperidone	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Long-term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MP-214 1.5-9mg	Drug: MP-214; 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
Active Comparator: Risperidone 2-12mg	Drug: Risperidone; 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

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [Up to 60 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 74 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 who meet at least one of the following:

• current diagnosis of schizophrenia of chronic phase

• between 65 and 74 years of age

• 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		Aizuwakamatsu	Fukushima	Japan

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: NCT01625897
• Other Study ID Numbers: A002-A7
• First Posted: Jun 22, 2012
• Last Update Posted: Apr 13, 2021
• Last Verified: Apr 1, 2021

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

Study Results

Participant Flow

Arm/Group Title	MP-214 1.5-9mg	Risperidone 2-12mg
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	83	42
COMPLETED	31	28
NOT COMPLETED	52	14

Baseline Characteristics

Arm/Group Title	MP-214 1.5-9mg	Risperidone 2-12mg	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	83	42	125
Age, Customized (Count of Participants)
>=20 and <65 years	66 79.5%	32 76.2%	98 78.4%
>=65 and <74 years	17 20.5%	10 23.8%	27 21.6%
Sex: Female, Male (Count of Participants)
Female	44 53%	18 42.9%	62 49.6%
Male	39 47%	24 57.1%	63 50.4%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame	Up to 60 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MP-214 1.5-9mg	Risperidone 2-12mg
Arm/Group Description	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	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
Measure Participants	83	42
Count of Participants [Participants]	78 94%	42 100%

Adverse Events

Arm/Group Title	MP-214 1.5-9mg		Risperidone 2-12mg
Arm/Group Description	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		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
All Cause Mortality
	MP-214 1.5-9mg		Risperidone 2-12mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	MP-214 1.5-9mg		Risperidone 2-12mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/83 (15.7%)		4/42 (9.5%)
Hepatobiliary disorders
Cholangitis	0/83 (0%)		1/42 (2.4%)
Infections and infestations
Diverticulitis	1/83 (1.2%)		0/42 (0%)
Injury, poisoning and procedural complications
Toxicity to various agents	1/83 (1.2%)		0/42 (0%)
Metabolism and nutrition disorders
Diabetes mellitus inadequate control	1/83 (1.2%)		0/42 (0%)
Nervous system disorders
Brain stem haemorrhage	1/83 (1.2%)		0/42 (0%)
Psychiatric disorders
Schizophrenia	9/83 (10.8%)		3/42 (7.1%)
Other (Not Including Serious) Adverse Events
	MP-214 1.5-9mg		Risperidone 2-12mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	72/83 (86.7%)		39/42 (92.9%)
Endocrine disorders
Hyperprolactinaemia	6/83 (7.2%)		16/42 (38.1%)
Gastrointestinal disorders
Constipation	7/83 (8.4%)		3/42 (7.1%)
Dental caries	2/83 (2.4%)		4/42 (9.5%)
Diarrhoea	6/83 (7.2%)		2/42 (4.8%)
Nausea	15/83 (18.1%)		5/42 (11.9%)
Vomiting	8/83 (9.6%)		3/42 (7.1%)
General disorders
Malaise	3/83 (3.6%)		4/42 (9.5%)
Hepatobiliary disorders
Hepatic function abnormal	8/83 (9.6%)		0/42 (0%)
Infections and infestations
Influenza	1/83 (1.2%)		3/42 (7.1%)
Nasopharyngitis	26/83 (31.3%)		14/42 (33.3%)
Investigations
Blood creatine phosphokinase increased	8/83 (9.6%)		4/42 (9.5%)
Blood prolactin increased	9/83 (10.8%)		12/42 (28.6%)
Blood urine present	5/83 (6%)		1/42 (2.4%)
Weight increased	6/83 (7.2%)		6/42 (14.3%)
Musculoskeletal and connective tissue disorders
Back pain	7/83 (8.4%)		4/42 (9.5%)
Nervous system disorders
Akathisia	5/83 (6%)		8/42 (19%)
Headache	5/83 (6%)		5/42 (11.9%)
Parkinsonism	2/83 (2.4%)		6/42 (14.3%)
Somnolence	8/83 (9.6%)		5/42 (11.9%)
Insomnia	14/83 (16.9%)		12/42 (28.6%)
Schizophrenia	28/83 (33.7%)		11/42 (26.2%)
Suicidal ideation	3/83 (3.6%)		4/42 (9.5%)
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation	0/83 (0%)		3/42 (7.1%)
Skin and subcutaneous tissue disorders
Eczema	3/83 (3.6%)		3/42 (7.1%)
Vascular disorders
Hypertension	6/83 (7.2%)		1/42 (2.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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