- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01626859
A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia
April 8, 2021 updated by: Mitsubishi Tanabe Pharma Corporation
A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia (12 Weeks Treatment Study)
The objective of this study is to evaluate the pharmacokinetics, safety and efficacy of MP-214 in patients with schizophrenia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Osaka
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Sakai, Osaka, Japan
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MP-214 3mg
|
Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.
|
Experimental: MP-214 6mg
|
Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks.
|
Experimental: MP-214 9mg
|
Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: Up to 24 weeks
|
Up to 24 weeks
|
Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84
Time Frame: On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.
|
On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.
|
Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84
Time Frame: On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.
|
On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.
|
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 84
Time Frame: On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.
|
On Day 84 samples were taken pre-dose and 3, 4, 6 and 8 hours post-dose.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
June 19, 2012
First Submitted That Met QC Criteria
June 20, 2012
First Posted (Estimate)
June 25, 2012
Study Record Updates
Last Update Posted (Actual)
April 12, 2021
Last Update Submitted That Met QC Criteria
April 8, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A002-A11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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