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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04334317 | A Study of TAK-071 in People With Parkinson Disease | PHASE2 | COMPLETED | 64 | — | — | Oct 21, 2020 | Feb 27, 2023 | May 14, 2024 | 21 | United States |
Stride time (or gait) is defined as the time elapsed between the first contact of two consecutive footsteps of the same foot and is expressed in seconds. The standard deviation (SD) of the stride time, recorded for each foot during the 2-minutes, is averaged to obtain stride time (gait) variability. The 2-minute walk was performed with and without simultaneous performance of serial 3 subtraction, which adds a cognitive load to the task. Data are reported with and without cognitive load.
| Arm | Type | Description |
|---|---|---|
| Placebo + TAK-071 (PD Participants) | EXPERIMENTAL | TAK-071 placebo-matching tablets, orally, once daily for up to first 6 weeks in Period 1, followed by ≥3 weeks washout period, followed by TAK-071 tablets, orally, once daily for up to next 6 weeks in Period 2. |
| TAK-071 + Placebo (PD Participants) | EXPERIMENTAL | TAK-071 tablets, orally, once daily for up to first 6 weeks in Period 1, followed by ≥3 weeks washout period, followed by TAK-071 placebo-matching tablets, orally, once daily for up to next 6 weeks in Period 2. |
| Sentinel Cohort: Placebo (Healthy Participants) | EXPERIMENTAL | A single dose of TAK-071 placebo-matching mg, tablet, orally, on Day 1. |
| Sentinel Cohort: TAK-071 7.5 mg (Healthy Participants) | EXPERIMENTAL | A single dose of TAK-071 ≤ 7.5 milligrams (mg), tablet, orally, on Day 1. |
| Name | Type | Description |
|---|---|---|
| TAK-071 | DRUG | TAK-071 tablet. |
| Placebo | DRUG | TAK-071 placebo-matching tablet. |
Key Inclusion Criteria: 1. Is an outpatient of any sex aged between 40 and ≤ 85 years, inclusive, at the time of consent. 2. Has a diagnosis of PD according to Movement Disorders Society (MDS) clinical diagnostic criteria for PD. Participants with DLB (i.e., dementia diagnosed before onset of motor...