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TAK-071

Phase 2

Parkinson Disease | Small molecule | Neurology |Takeda Pharmaceutical Company Limited|Last Updated: May 14, 2024

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

TAK-071 · 1 trial · 2 indications

Phase 2 1
NCT04334317A Study of TAK-071 in People With Parkinson DiseaseParkinson Disease
COMPLETED64 Analytics
PHASE2COMPLETED
A Study of TAK-071 in People With Parkinson Disease
Parkinson DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Main Cohort: Change From Baseline in Stride Time (Gait) Variability During a 2-minute Dual-Task Walking Test After 6-week Treatment With TAK-071 Compared With Placebo
Baseline and Week 6 (for each study period)

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.

Sentinel Cohort, Cmax: Maximum Observed Plasma Concentration for TAK-071 in Healthy Participants
Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours)
Sentinel Cohort, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-071 in Healthy Participants
Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours)
Sentinel Cohort, AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours for TAK-071 in Healthy Participants
Day 1: Predose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours post dose
Sentinel Cohort, AUClast: Area Under The Concentration-Time Curve From Time 0 To The Last Quantifiable Concentration in Healthy Participants
Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours)
Sentinel Cohort, AUCinf: Area Under The Concentration-Time Curve From Time 0 To Infinity in Healthy Participants
Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours)

Secondary Endpoints

Main Cohort: Change From Baseline in Global Cognition Z-score
Baseline and Week 6 (for each study period)
Main Cohort: Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-071 in Parkinson Disease (PD) Participants
Day 42 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose
Main Cohort, Cmax: Maximum Observed Plasma Concentration for TAK-071 in PD Participants
Day 1 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Placebo + TAK-071 (PD Participants)EXPERIMENTALTAK-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)EXPERIMENTALTAK-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)EXPERIMENTALA single dose of TAK-071 placebo-matching mg, tablet, orally, on Day 1.
Sentinel Cohort: TAK-071 7.5 mg (Healthy Participants)EXPERIMENTALA single dose of TAK-071 ≤ 7.5 milligrams (mg), tablet, orally, on Day 1.

Interventions

NameTypeDescription
TAK-071DRUGTAK-071 tablet.
PlaceboDRUGTAK-071 placebo-matching tablet.
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Eligibility Criteria

Age Range40 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites21

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...

Countries:United States
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Frequently asked questions about TAK-071

What is TAK-071 used for in Parkinson Disease?

TAK-071 is an investigational small molecule being studied for the treatment of Parkinson Disease. It is a Phase 2 drug candidate developed by Takeda Pharmaceutical Company Limited. The drug is being evaluated in a clinical trial involving participants with Parkinson Disease and healthy participants.

How does TAK-071 work?

TAK-071 is a small molecule being developed for Parkinson Disease. Its specific molecular target has not been disclosed in the available information. The drug is being studied for its potential effects in people with Parkinson Disease, though the exact mechanism of action is not publicly detailed.

Who makes TAK-071?

TAK-071 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical research on this investigational drug for Parkinson Disease. TAK-071 is currently in Phase 2 development.

What phase is TAK-071 in?

TAK-071 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for Parkinson Disease, and one Phase 2 trial has been completed.

What clinical trials is TAK-071 in?

TAK-071 has been studied in a Phase 2 clinical trial with the identifier NCT04334317. This trial, titled "A Study of TAK-071 in People With Parkinson Disease," was conducted in the United States and enrolled 64 participants. The trial included both people with Parkinson Disease and healthy participants.

Is TAK-071 the same as any other drug?

TAK-071 is the primary name for this investigational drug candidate. No alternative names have been reported for this compound. It is being developed by Takeda Pharmaceutical Company Limited for the treatment of Parkinson Disease.