Phase 2
N=34
Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00862992 ↗Enrolled (actual)
34
Serious AEs
17.7%
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants With Adverse Event and Adverse Drug Reaction — 9; 9; 11; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cariprazine 3 mg (Drug); Cariprazine 6 mg (Drug); Cariprazine 12.5 mg (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Tanabe Pharma Corporation
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Event and Adverse Drug Reaction |
9; 9; 11; 5; 6; 10 | — |
| SECONDARY Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14 |
9.19; 19.43; 36.39; 3.14; 5.83; 11.37 | — |
| SECONDARY Time to Maximum Plasma Concentration of Unchanged MP-214, M7 (Desmethyl Cariprazine) and M6 (Didesmethyl Cariprazine) at Day 14 |
3.71; 3.48; 3.22; 5.25; 5.10; 4.36 | — |
| SECONDARY 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 |
298.36; 522.38; 1017.96; 135.25; 232.38; 437.64 | — |
Summary
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of 3 fixed doses of MP-214 orally administered once daily to patients with schizophrenia. MP-214 tablets will be administered to patients starting at an initial dose, followed by up-titration to a fixed dose (low, medium or high) for 14 days.
Eligibility Criteria
Inclusion Criteria
- Patients meeting DSM-IV-TR criteria for schizophrenia
- PANSS total score <= 120 during the observation period
- Patients who have been treated with oral antipsychotics within 4 weeks before informed consent
- Patients whose consent is obtained from themselves in written form
Exclusion Criteria
- Patients who have defined as any mental disorder other than "Schizophrenia" based on the criteria of DSM-IV-TR
- History of drug or alcohol abuse
- Concurrent Parkinson's disease
- History of, or concurrent spastic disorders like epilepsy, cerebrovascular disease, anuresis or adynamic(= paralytic) ileus, malignant syndrome, diabetes, hepatic disorder
- Patients who exhibit abnormalities on Physical Examination, have abnormal vital signs, ECG, or clinical laboratory values
- Current cataract during the observation period
- History of shock or anaphylactoid symptoms to drugs
The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT00862992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.