Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02477020 | A Phase 2 Efficacy and Safety Study of TAK-063 in Participants With an Acute Exacerbation of Schizophrenia | PHASE2 | COMPLETED | 164 | — | — | Jul 1, 2015 | Jul 27, 2016 | May 8, 2026 | 15 | United States |
| NCT01879722 | Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of TAK- 063 in Participants With Stable Schizophrenia and Healthy Participants | PHASE1 | COMPLETED | 77 | — | — | Jun 1, 2013 | Jun 1, 2014 | May 8, 2026 | 1 | United States |
PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity. Least square mean and standard error values were determined using a mixed model for repeated measures (MMRM). A negative change from Baseline indicates improvement.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period.
The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse, and resting blood pressure and after standing
The percentage of participants who meet markedly abnormal criteria specified by the protocol and statistical analysis plan during the treatment period.
| Arm | Type | Description |
|---|---|---|
| TAK-063 20 mg | EXPERIMENTAL | TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks. Dose may be titrated down to 10 mg/day, if intolerable. |
| Placebo | PLACEBO_COMPARATOR | TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks. |
| TAK-063 3 mg | EXPERIMENTAL | TAK-063 3 mg, tablets, orally, once daily for 7 days. |
| TAK-063 10 mg | EXPERIMENTAL | TAK-063 10 mg, tablets, orally, once daily for 7 days. |
| TAK-063 30 mg | EXPERIMENTAL | TAK-063 30 mg, tablets, orally, once daily for 7 days. |
| TAK-063 100 mg | EXPERIMENTAL | TAK-063 100 mg, tablets, orally, once daily for 7 days. |
| Name | Type | Description |
|---|---|---|
| TAK-063 20 mg | DRUG | TAK-063 tablet. |
| Placebo | DRUG | TAK-063 matching-placebo tablet. |
| TAK-063 | DRUG | TAK-063 tablets |
| TAK-063 Placebo | DRUG | TAK-063 placebo-matching tablets |
Inclusion Criteria: 1. Is capable of understanding and complying with protocol requirements. 2. The participants or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation o...